U.S. patent application number 10/144641 was filed with the patent office on 2002-12-19 for food bars containing nutritional supplements and anti-constipation and regularity-maintaining agents.
This patent application is currently assigned to PBM Pharmaceuticals, Inc.. Invention is credited to Manning, Paul B., McGrath, James W. JR., Schramm, Jack H..
Application Number | 20020192265 10/144641 |
Document ID | / |
Family ID | 24934337 |
Filed Date | 2002-12-19 |
United States Patent
Application |
20020192265 |
Kind Code |
A1 |
Manning, Paul B. ; et
al. |
December 19, 2002 |
Food bars containing nutritional supplements and anti-constipation
and regularity-maintaining agents
Abstract
The present invention provides food bars for consumption by
pregnant women, lactating women or women of childbearing potential
that are attempting to become pregnant containing one or more
vitamins and/or minerals, and one or more anti-constipation and
regularity-maintaining agents, methods for preparing these food
bars, and methods for supplementing the dietary requirements of
pregnant women, lactating women or women of childbearing potential
that are attempting to become pregnant. The food bars of the
invention generally comprise one or more vitamins and minerals
recommended for consumption by pregnant women, lactating women or
women of childbearing potential that are attempting to become
pregnant in an amount that is effective for enhancing the nutrition
of pregnant women, lactating women or women of childbearing
potential that are attempting to become pregnant, and that is not
harmful to developing fetuses or breast-feeding babies, one or more
anti-constipation and regularity-maintaining agents in an amount
that is effective for reducing or eliminating constipation, and
that is not harmful to developing fetuses or breast-feeding babies,
from about 0 to about 99 weight percent of carbohydrates, from
about 0 to about 80 weight percent of proteins, and from about 0 to
about 60 weight percent of fats.
Inventors: |
Manning, Paul B.; (Keswick,
VA) ; Schramm, Jack H.; (Gordonsville, VA) ;
McGrath, James W. JR.; (Keswick, VA) |
Correspondence
Address: |
David G. Greene, Esq.
LORD, BISSELL & BROOK
1900 The Proscenium
1170 Peachtree Street NE
Atlanta
GA
30309
US
|
Assignee: |
PBM Pharmaceuticals, Inc.
|
Family ID: |
24934337 |
Appl. No.: |
10/144641 |
Filed: |
May 13, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10144641 |
May 13, 2002 |
|
|
|
09730194 |
Dec 5, 2000 |
|
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|
Current U.S.
Class: |
424/439 ;
426/72 |
Current CPC
Class: |
A23V 2250/704 20130101;
A23V 2250/702 20130101; A23V 2002/00 20130101; A23V 2002/00
20130101; A23G 3/368 20130101; A23L 33/40 20160801; A23V 2250/156
20130101; A23V 2002/00 20130101; A23V 2250/5114 20130101; A23V
2250/70 20130101; A23V 2250/71 20130101; A23V 2250/712 20130101;
A23V 2250/1868 20130101; A23V 2250/54252 20130101; A23V 2250/64
20130101; A23V 2250/156 20130101; A23V 2250/194 20130101; A23V
2250/708 20130101; A23V 2250/1868 20130101 |
Class at
Publication: |
424/439 ;
426/72 |
International
Class: |
A61K 047/00; A23L
001/30 |
Claims
What is claimed is:
1. A food bar comprising: (a) one or more vitamins and minerals
recommended for consumption by pregnant women, lactating women or
women of childbearing potential that are attempting to become
pregnant in an amount that is effective for enhancing the nutrition
of pregnant women, lactating women or women of childbearing
potential that are attempting to become pregnant, and that is not
harmful to developing fetuses or breast-feeding babies; and (b) one
or more anti-constipation and regularity-maintaining agents in an
amount that is effective for maintaining regularity of bowel
movements, or for reducing or eliminating constipation, and that is
not harmful to developing fetuses or breast-feeding babies; wherein
the food bar supplements the dietary requirements of pregnant
women, lactating women or women of childbearing potential that are
attempting to become pregnant.
2. The food bar of claim 1 wherein the food bar additionally
comprises: (a) from about 1 to about 99 weight percent of
carbohydrates; (b) from about 1 to about 80 weight percent of
proteins; and (c) from about 1 to about 60 weight percent of
fats.
3. The food bar of claim 1 wherein the one or more vitamins and
minerals are Vitamin A, Vitamin B.sub.1, Vitamin B.sub.2, Vitamin
B.sub.3, Vitamin B.sub.6, Folic Acid, Vitamin B.sub.12, Biotin,
Vitamin C, Vitamin D, Vitamin E, Vitamin K, Niacinamide,
Tocopheryl, Calcium, Iron, Folacin, Phosphorus, Pantothenic Acid,
Iodine, Magnesium, Zinc, Selenium, Copper, Manganese, Chromium,
Molybdenum, Choline, Fluoride, Chloride, Potassium or Sodium.
4. The food bar of claim 3 wherein the one or more
anti-constipation and regularity-maintaining agents are calcium
polycarbophyll, psyllium, methylcellulose or bran.
5. The food bar of claim 4 wherein the one or more vitamins and
minerals are present in an amount ranging from about 2.5 to about
50 weight percent of the food bar.
6. The food bar of claim 5 wherein the one or more
anti-constipation and regularity-maintaining agents are present in
an amount ranging from about 0.1 to about 80 weight percent of the
food bar.
7. The food bar of claim 6 wherein the one or more vitamins and
minerals are present in an amount ranging from about 5 to about 25
weight percent of the food bar.
8. The food bar of claim 7 wherein the one or more
anti-constipation and regularity-maintaining agents are present in
an amount ranging from about 1 to about 60 weight percent of the
food bar.
9. The food bar of claim 8 wherein the carbohydrates are present in
an amount ranging from about 1 to about 60 weight percent of the
food bar.
10. The food bar of claim 9 wherein the proteins are present in an
amount ranging from about 20 to about 60 weight percent of the food
bar.
11. The food bar of claim 10 wherein the fats are present in an
amount ranging from about 1 to about 40 weight percent of the food
bar.
12. The food bar of claim 11 wherein the food bar has a shelf life
of about six to twenty-four months at normal room temperature.
13. The food bar of claim 3 wherein the food bar contains calcium
in an amount ranging from about 1,000 mg to about 3,000 mg.
14. The food bar of claim 13 wherein the food bar contains about
1,300 mg of calcium.
15. The food bar of claim 3 wherein the food bar contains folic
acid in an amount ranging from about 1,000 mcg to about 2,000
mcg.
16. The food bar of claim 15 wherein the food bar contains about
1,000 mcg of folic acid.
17. The food bar of claim 2 wherein the food bar is partially or
fully produced without the use of heat.
18. The food bar of claim 17 wherein the food bar is fully produced
without the use of heat.
19. The food bar of claim 2 wherein the food bar is produced
without baking.
20. The food bar of claim 11 wherein the food bar does not contain
taurine.
21. The food bar of claim 11 wherein the food bar does not contain
more than one wafer stacked one above the other.
22. The food bar of claim 11 wherein the food bar does not contain
any marshmallow or flour.
23. The food bar of claim 11 wherein the food bar contains only one
layer.
24. The food bar of claim 11 wherein the food bar contains less
than 250 calories.
25. The food bar of claim 11 wherein the food bar additionally
comprises DHA.
26. The food bar of claim 11 wherein the food bar additionally
comprises from about 1 to about 3 weight percent of a
preservative.
27. The food bar of claim 26 wherein the preservative is sodium
benzolate.
28. The food bar of claim 11 wherein the food bar contains a
caramel layer.
29. The food bar of claim 28 wherein the food bar contains a
chocolate coating.
30. The food bar of claim 28 wherein the one or more vitamins and
minerals are present within the caramel.
31. The food bar of claim 11 wherein the food bar additionally
comprises from about 0.05 to about 2 weight percent of an agent
that masks bitter or off taste of other ingredients present in the
food bar.
32. The food bar of claim 11 wherein the food bar contains the
following vitamins and minerals, and quantities thereof: Vitamin
A--from about 0 to about 9,000 I.U. Vitamin B.sub.1--from about 0
to about 50 mg Vitamin B.sub.2--from about 0 to about 50 mg Vitamin
B.sub.3--from about 0 to about 60 mg Vitamin B.sub.6--from about 0
to about 50 mg Vitamin B.sub.9/M--from about 0 to about 2,000 mcg
Vitamin B.sub.12--from about 0 to about 1,000 mcg Biotin--from
about 0 to about 600 mcg Vitamin C--from about 0 to about 1,000 mg
Vitamin D--from about 0 to about 800 I.U. Vitamin E--from about 0
to about 1,500 I.U. Vitamin K--from about 0 to about 80 mcg
Calcium--from about 0 to about 3,000 mg Iron--from about 0 to about
100 mg Phosphorus--from about 0 to about 2,000 mg Pantothenic
Acid--from about 0 to about 20 mg Iodine--from about 0 to about 200
mcg Magnesium--from about 0 to about 600 mg Zinc--from about 0 to
about 30 mg Selenium--from about 0 to about 400 mcg Copper--from
about 0 to about 2 mg Manganese--from about 0 to about 5 mg
Chromium--from about 0 to about 150 mcg Molybdenum--from about 0 to
about 75 mcg Choline--from about 0 to about 1,000 mg Fluoride--from
about 0 to about 5 mg Chloride--from about 0 to about 3,400 mg
Potassium--from about 0 to about 80 mg Sodium--from about 0 to
about 2,400 mg.
33. The food bar of claim 32 wherein the food bar contains the
following vitamins and minerals, and quantities thereof: Vitamin
A--from about 1,000 to about 7,000 I.U. Vitamin B.sub.1--from about
1.4 to about 10 mg Vitamin B.sub.2--from about 1.6 to about 25 mg
Vitamin B.sub.3--from about 17 to about 40 mg Vitamin B.sub.6--from
about 2.2 to about 40 mg Vitamin B.sub.9.mu.M--from about 400 to
about 1,000 mcg Vitamin B.sub.12--from about 2.6 to about 18 mcg
Biotin--from about 30 to about 400 mcg Vitamin C--from about 80 to
about 500 mg Vitamin D--from about 200 to about 400 I.U. Vitamin
E--from about 10 to about 400 I.U. Vitamin K--from about 10 to
about 65 mcg Calcium--from about 200 to about 2,000 mg Iron--from
about 18 to about 90 mg Phosphorus--from about 100 to about 1,250
mg Pantothenic Acid--from about 6 to about 15 mg Iodine--from about
175 to about 200 mcg Magnesium--from about 200 to about 500 mg
Zinc--from about 1 to about 25 mg Selenium--from about 60 to about
100 mcg Copper--from about 0.1 to about 2 mg Manganese--from about
0.1 to about 5 mg Chromium--from about 0.1 to about 120 mcg
Molybdenum--from about 0.1 to about 50 mcg Choline--from about 300
to about 600 mg Fluoride--from about 1 to about 4 mg Chloride--from
about 10 to about 1,000 mg Potassium--from about 10 to about 80 mg
Sodium--from about 10 to about 1,000 mg.
34. The food bar of claim 32 wherein the food bar is recommended
for consumption by pregnant women, the food bar supplements the
dietary requirements of pregnant women, and the food bar contains
the following vitamins and minerals, and quantities thereof:
Vitamin A--about 5,000 I.U. Vitamin B.sub.1--about 3 mg Vitamin
B.sub.2--about 3.4 mg Vitamin B.sub.3--about 20 mg Vitamin
B.sub.6--about 10 mg Vitamin B.sub.9/M--about 1,000 mcg Vitamin
B.sub.12--about 12 mcg Biotin--about 30 mcg Vitamin C--about 120 mg
Vitamin D--about 400 I.U. Vitamin E--about 30 I.U. Vitamin K--about
10 mcg Calcium--about 1,300 mg Iron--about 27 mg Phosphorus--about
100 mg Pantothenic Acid--about 10 mg Iodine--about 175 mcg
Magnesium--about 400 mg Zinc--about 10 mg Selenium--about 60 mcg
Copper--about 2 mg Manganese--about 5 mg Chromium--about 25 mcg
Molybdenum--about 25 mcg Choline--about 450 mg.
35. The food bar of claim 32 wherein the food bar is recommended
for consumption by lactating women, the food bar supplements the
dietary requirements of lactating women, and the food bar contains
the following vitamins and minerals, and quantities thereof:
Vitamin A--about 7,000 I.U. Vitamin B.sub.1--about 3.2 mg Vitamin
B.sub.2--about 3.9 mg Vitamin B.sub.3--about 24 mg Vitamin
B.sub.6--about 9.5 mg Vitamin B.sub.9/M--about 400 mcg Vitamin
B.sub.12--about 14 mcg Biotin--about 35 mcg Vitamin C--about 163 mg
Vitamin D--about 400 I.U. Vitamin E--about 36 I.U. Vitamin K--about
10 mcg Calcium--about 1,300 mg Iron--about 27 mg Phosphorus--about
100 mg Pantothenic Acid--about 10 mg Iodine--about 200 mcg
Magnesium--about 360 mg Zinc--about 10 mg Selenium--about 70 mcg
Copper--about 2 mg Manganese--about 5 mg Chromium--about 25 mcg
Molybdenum--about 25 mcg Choline--about 550 mg.
36. The food bar of claim 11 wherein the food bar additionally
comprises about 300 mg DHA, about 1000 mg calcium polycarbophil,
and contains the following vitamins and minerals, and quantities
thereof: Vitamin A--about 5,000 I.U. Vitamin B.sub.1--about 3 mg
Vitamin B.sub.2--about 3.4 mg Vitamin B.sub.3--about 20 mg Vitamin
B.sub.6--about 10 mg Vitamin B.sub.9/M--about 1 mg Vitamin
B.sub.12--about 12 mcg Biotin--about 30 mcg Vitamin C--about 120 mg
Vitamin D--about 400 I.U. Vitamin E--about 30 I.U. Calcium--about
1,300 mg Iron--about 27 mg Pantothenic Acid--about 10 mg
Iodine--about 150 mcg Magnesium--about 400 mg Zinc--about 25 mg
Selenium--about 70 mcg Copper--about 2 mg Manganese--about 5 mg
Chromium--about 25 mcg Molybdenum--about 25 mcg
37. A method for preparing food bars comprising: (a) forming a
blend of one or more oil-soluble vitamins and minerals recommended
for consumption by pregnant women, lactating women or women of
childbearing potential that are attempting to become pregnant in an
amount that is effective for enhancing the nutrition of pregnant
women, lactating women, or women of childbearing potential that are
attempting to become pregnant, and that is not harmful to
developing fetuses or breast-feeding babies, with a fat that has
been heated to a temperature ranging from about 160.degree. F. to
about 180.degree. F., wherein the fat ranges from about 1 to about
60 weight percent of the food bars; (b) cooling the blend of step
(a) to a temperature ranging from about 135.degree. F. to about
150.degree. F.; (c) mixing the blend of step (b) with one or more
anti-constipation and regularity-maintaining agents in an amount
that is effective for maintaining regularity of bowel movements, or
for reducing or eliminating constipation, and that is not harmful
to developing fetuses or breast-feeding babies, until a blend is
obtained; (d) extruding the blend of step (c) to produce bars of a
desired shape and size; and (e) placing a top layer upon the bars
of step (d) in an amount ranging from about 5 to about 50 weight
percent of the food bars, wherein the top layer contains one or
more water-soluble vitamins and minerals recommended for
consumption by pregnant women, lactating women or women of
childbearing potential that are attempting to become pregnant in an
amount that is effective for enhancing the nutrition of pregnant
women, lactating women, or women of childbearing potential that are
attempting to become pregnant and that is not harmful to developing
fetuses or breast-feeding babies; wherein the food bars supplement
the dietary requirements of pregnant women, lactating women or
women of childbearing potential that are attempting to become
pregnant.
38. The method of claim 37 wherein the method further comprises the
step of placing an artificial chocolate coating upon the bars of
step (e), wherein the artificial chocolate coating is in an amount
ranging from about 5 to about 30 weight percent of the food
bars.
39. The method of claim 37 wherein the method further comprises the
step of packaging each food bar in a separate hermetically sealed
package having a nitrogen atmosphere enclosed by a barrier
film.
40. The method of claim 39 wherein the method further comprises the
step of adding the sealed package to an aluminum can, purging the
can with a nitrogen atmosphere and vacuum sealing the can.
41. The method of claim 37 wherein the method additionally
comprises the step of irradiating the bars of step (e) prior to
packaging.
42. A method for supplementing the dietary requirements of pregnant
women, lactating women or women of childbearing potential that are
attempting to become pregnant comprising administering to the
pregnant women, lactating women or women of childbearing potential
that are attempting to become pregnant one or more food bars
containing: (a) one or more vitamins and minerals recommended for
consumption by pregnant women, lactating women or women of
childbearing potential that are attempting to become pregnant in an
amount that is effective for enhancing the nutrition of pregnant
women, lactating women or women of childbearing potential that are
attempting to become pregnant, and that is not harmful to
developing fetuses or breast-feeding babies; (b) one or more
anti-constipation and regularity-maintaining agents in an amount
that is effective for maintaining regularity of bowel movements or
reducing or eliminating constipation, and that is not harmful to
developing fetuses or breast-feeding babies; (c) from about 1 to
about 99 weight percent of carbohydrates; (d) from about 1 to about
80 weight percent of proteins; and (e) from about 1 to about 60
weight percent of fats; wherein the food bars supplement the
dietary requirements of pregnant women, lactating women or women of
childbearing potential that are attempting to become pregnant.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to food bars for consumption
by pregnant women, lactating women, or women having childbearing
potential that are attempting to become pregnant containing one or
more vitamins and/or minerals, and one or more anti-constipation
and regularity-maintaining agents, to methods for preparing these
food bars, and to methods for enhancing the nutrition of pregnant
women and their developing fetuses, of lactating women and their
babies, and of women having childbearing potential that are
attempting to become pregnant. In particular, the present invention
relates to food bars comprising one or more vitamins and/or
minerals recommended for consumption by pregnant women, lactating
women, or women having childbearing potential that are attempting
to become pregnant in an amount that is effective for enhancing the
nutrition of pregnant women, lactating women, or women having
childbearing potential that are attempting to become pregnant, or
of their developing fetuses or babies, and one or more
anti-constipation and regularity-maintaining agents in an amount
that is effective for reducing or eliminating constipation, and/or
for maintaining regularity of bowel movements, in pregnant women,
lactating women, or women having childbearing potential that are
attempting to become pregnant.
[0003] 2. Background
[0004] The daily Recommended Dietary Allowances of water-soluble
vitamins for non-pregnant and pregnant women, and the rationale for
increased allowances during pregnancy, is set forth in Nutrition
During Pregnancy (Nat'l Academy Press, 1990), and below.
1 Recommended Dietary Allowance Nonpregnant Pregnant Rationale for
Increased Vitamin Women Women Allowance for Pregnancy Vitamin C 60
mg 70 mg To provide for fetal needs. At term, fetal plasma levels
are 50% higher than maternal levels. Thiamin 1.1 mg 1.5 mg To
accommodate maternal and fetal growth and increased energy
allowance during pregnancy. Riboflavin 1.3 mg 1.6 mg To provide for
increased maternal and fetal synthesis. Niacin (NE).sup.1 15 mg 17
mg Based upon energy increase of 300 kcal/day for pregnancy.
Vitamin B.sub.6 1.6 mg 2.2 mg Based partially on the additional
protein allowance of 10 g/day for pregnancy. Folate 190 .mu.g 400
.mu.g Based on 50% food folate absorption. To build or maintain
maternal folate stores and to provide for increased folate turnover
in rapidly growing tissue. Vitamin B.sub.12 2.0 .mu.g 2.2 .mu.g
Fetal needs (0.1-0.2 .mu.g/day) based on analysis of stillborn
fetuses. Metabolic needs of pregnancy estimated at 0.2 .mu.g/day.
.sup.11 NE (niacin equivalent) = 1 mg of niacin or 60 mg of
tryptophan.
[0005] The daily Recommended Dietary Allowances (RDAs) and
Estimated Safe and Adequate Daily Dietary Intakes (ESADDIs)
compared with the U.S. Recommended Daily Allowances (U.S. RDAs)
established by the U.S. Food and Drug Administration of protein,
vitamins and minerals for non-pregnant, pregnant and lactating
women is set forth in Nutrition During Pregnancy (Nat'l Academy
Press, 1990), and below.
2 U.S. RDA RDA or ESADDI Non- Pregnant for Pregnant Pregnant or
Lactating Nutrient Adult Women Women Women RDA Protein 60 g 65 g 65
g Vitamin A 800 mg RE.sup.1 5,000 IU 8,000 IU Vitamin D 10 .mu.g
400 IU 400 IU Vitamin E 10 mg of .alpha.-TE.sup.2 30 IU 30 IU
Vitamin K 65 .mu.g Not Established Not Established Vitamin C 70 mg
60 mg 60 mg Thiamin 1.5 mg 1.5 mg 1.7 mg Riboflavin 1.6 mg 1.7 mg
2.0 mg Niacin 17 mg NE.sup.3 20 mg 20 mg Vitamin B.sub.6 2.2 mg 2.0
mg 2.5 mg Folacin 400 .mu.g 400 .mu.g 800 .mu.g Vitamin B.sub.12
2.2 .mu.g 6 .mu.g 8 .mu.g Calcium 1,200 mg 1,000 mg 1,300 mg
Phosphorus 1,200 mg 1,000 mg 1,300 mg Magnesium 300 mg 400 mg 450
mg Iron 30 mg 18 mg 18 mg Zinc 15 mg 15 mg 15 mg Iodine 175 .mu.g
150 .mu.g 150 .mu.g Selenium 65 .mu.g Not Established Not
Established ESADDI Biotin 30-100 .mu.g 300 .mu.g 300 .mu.g
Pantothenic 4-7 mg 10 mg 10 mg Acid Copper 1.5-3.0 mg 2 mg 2 mg
Manganese 2.5-5.0 mg Not Established Not Established Fluoride
1.5-4.0 mg Not Established Not Established Chromium 50-200 .mu.g
Not Established Not Established Molybdenum 75-250 .mu.g Not
Established Not Established .sup.11 RE (retinol equivalent) = 1
.mu.g of retinol, 6 .mu.g of .beta.-carotene or 12 .mu.g of other
provitamin A carotenoids. .sup.21 .alpha.-TE (tocopherol
equivalent) = 1 mg of RRR-.alpha.-tocopherol = 1.49 IU of
RRR-.alpha.-tocopherol = 0.74 IU of all-RAC-.alpha.-tocopherol (the
synthetic form). .sup.31 NE (niacin equivalent) = 1 mg of niacin or
60 mg of dietary tryptophan.
[0006] Morning sickness generally causes a loss of appetite and a
feeling of nausea, and is experienced by a significant number of
pregnant women. Because they experience morning sickness, and
because the pills that contain the full dose of recommended
prenatal vitamins and minerals generally are very large in size,
many pregnant women are often reluctant to take their prenatal
vitamin and mineral pills. Further, when they do take these pills,
these pregnant women often experience difficulty swallowing and
retaining these pills, and take the pills without food. Vitamins
and minerals that are taken without food are not absorbed as well
as those taken with some food. Problems, thus, arise concerning
patient compliance (the daily consumption of vitamin and mineral
supplements), maintaining or enhancing the health of pregnant
woman, and the absorption of the quantity of vitamins and minerals
that are associated with proper fetal development. Moreover,
regurgitation after consuming a vitamin and mineral pill causes
loss of some or all of the nutrients that were originally present
in the pill.
[0007] Morning sickness generally occurs most frequently during the
first trimester of pregnancy. Defects in the neural tube of a
developing fetus (spina bifida) can also occur during the first
trimester of pregnancy, for example, during the first month of
gestation, before a woman may have become aware of her pregnancy.
These defects are known to be linked to an inadequate intake of
folic acid. It is well known that folic acid prevents neural tube
defects. Thus, folic acid should be consumed in sufficient
quantities by women of child-bearing ages. Folic acid has also been
shown to have beneficial cardiac effects, and to decrease the risk
of cervical dysplasia.
[0008] Calcium is critical for proper fetal development, and is
essential for the production of milk by women. The administration
of calcium to a pregnant or lactating woman also acts to prevent
early osteoporosis in the woman as a result of a calcium drain in
the woman during pregnancy or lactation.
[0009] A recent University of North Carolina at Chapel Hill study
that was described in an article appearing in a November, 2000,
issue of Science Daily magazine and entitled, "New Research Shows
Calcium Deficiency Permits Faster Lead Release from Pregnant
Women's Bones," showed that pregnant women who do not consume
enough calcium in their diets, or through supplements, show greater
increases in lead in their bloodstreams than pregnant women with
normal calcium levels. Bone tissue, which contains about 95% of the
body's lead, demineralizes more rapidly in pregnant women who are
getting less calcium in comparison with other pregnant women. Such
demineralization releases locked-up lead into the blood,
particularly during the second half of pregnancy, and may cause
harm to both pregnant women and their fetuses. (Past research has
linked lead to many adverse conditions, including nervous system
and possible cardiovascular problems.) This study also showed that
calcium consumption can minimize bone demineralization in pregnant
women, and that one variable associated with a reduced lead level
is a higher calcium intake. Calcium intake at the recommended daily
allowance level was found to protect somewhat against lead, and
higher calcium levels were found to correspond with even less lead.
The protective effect of calcium was found to become stronger as
pregnancy progressed.
[0010] Many other vitamins, minerals and other nutritional
supplements, such as those set forth hereinabove, are recommended
for pregnant and lactating women.
[0011] The classical solid dosage forms that have been used as
delivery systems for nutritional supplements, such as prenatal
vitamins and minerals, for pregnant and lactating women, for
example, tablets and capsules, have known concerns about their
proper disintegration and dissolution, and about the bioavailablity
of the nutritional supplements contained therein, and are often
harsh on the stomach. Further, these tablets and capsules generally
cannot contain more than about 500 mg of calcium, which is much
lower than the Recommended Dietary Allowance established for
pregnant women.
[0012] Unfortunately, pregnancy and lactation often interrupt the
regularity of women's bowel movements, and cause women to become
constipated (to experience difficulties having regular and
comfortable bowel movements). This, in turn, often results in the
women experiencing painful and unattractive hemorrhoids. The
constipation experienced by pregnant and lactating women is often
exacerbated by the effects of pre-natal doses of vitamins and/or
minerals, in particular, iron.
[0013] It would be beneficial to provide a product that is high in
nutritional value for pregnant women, lactating women, and women
having childbearing potential that are attempting to become
pregnant that properly disintegrates and dissolves, thereby
allowing the nutrients present therein to become bioavailable for
the consumer, that is gentle on the stomach, that encourages
patient compliance, that reduces or eliminates constipation, making
excretion more regular and comfortable, and that contains a large
quantity of calcium.
[0014] The food bars of the present invention advantageously are
desirable-tasting, are easily chewable, are gentle on the stomach,
and supplement the nutritional requirements of pregnant women,
lactating women, and women having childbearing potential that are
attempting to become pregnant. These food bars generally contain a
dispersed system of slowly-released vitamins and/or minerals in a
stable matrix for oral ingestion and absorption. The food bars
readily disintegrate and dissolve, are digestible, and provide a
bio-available form of nutritional supplementation for pregnant
women, lactating women, and women having childbearing potential
that are attempting to become pregnant. Because the food bars are
not in the form of large pills, tablets or capsules, and have a
desirable taste, these food bars also provide for an improved
patient compliance with the daily regime of consuming vitamin and
mineral supplements during an often difficult period of time.
Further, because they contain one or more anti-constipation and
regularity-maintaining agents, the food bars of the invention
generally help maintain regular bowel movements and reduce or
eliminate constipation, and associated painful and unattractive
hemorrhoids, which may occur during pregnancy or lactation, or
which may be a side effect resulting from the consumption of
certain nutritional supplements, such as iron. Thus, the food bars
of the invention permit the maintenance of more regular and
comfortable excretions of bowel movements by pregnant women,
lactating women, and women having childbearing potential that are
attempting to become pregnant. The food bars of the invention
overcome the shortcomings of other prenatal or lactation vitamin
and mineral supplements, such as large vitamin pills, and deliver
to pregnant women, lactating women, and women having childbearing
potential that are attempting to become pregnant specific doses of
vitamins, minerals and/or other nutritional supplements in a
bio-available absorption format. As a result of folic acid that may
be present therein, the food bars of the invention may also have
beneficial properties protecting against neural tube defects. In
addition, these food bars have the ability to deliver the
Recommended Dietary Allowance, or higher levels, of calcium in a
bio-available form to pregnant women, lactating women, and women
having childbearing potential that are attempting to become
pregnant. These are significantly greater quantities of calcium
than can be effectively delivered in a prenatal vitamin pill,
tablet or capsule. Further, the dispersed system of the food bars,
along with the chewing action of the women during consumption,
diminishes the concerns related to the disintegration and
dissolution of the classical solid dosage forms, and the
bioavailablity of the nutritional supplements contained
therein.
[0015] 3. Description of the Related Art
[0016] The Physicians' Desk Reference (49.sup.th Edition, 1995, and
54.sup.th Edition, 2000) describes a prenatal vitamin and mineral
tablet marketed by Lederle Laboratories (Waynem, N.J.) under the
trademark name Materna.RTM. (pages 1264 and 1534,
respectively).
[0017] U.S. Pat. No. 2,634,210 discloses chocolate food products,
including bars (FIGS. 1 and 2), having two or more layers, and
vitamins and minerals dispersed in one or more of the layers. This
patent does not describe single-layer food bars, the use of
anti-constipation and regularity-maintaining agents or folic acid
in food bars, or the administration of food bars to pregnant or
lactating women.
[0018] U.S. Pat. No. 3,814,819 discloses a protein fortified food
bar of a controlled calorie content that contains a vitamin and
mineral mixture, and that is composed of several crisp wafers
stacked one above the other with a creamy filling between the
wafers. This patent does not describe single-layer food bars, the
use of anti-constipation and regularity-maintaining agents or folic
acid in food bars, or the administration of food bars to pregnant
or lactating women.
[0019] U.S. Pat. No. 4,018,901 discloses a high protein food bar
that has a marshmallow matrix as a base, and a water activity less
than 0.85, and that may include fat-coated vitamins. This patent
does not describe the use of anti-constipation and
regularity-maintaining agents or folic acid in food bars, or the
administration of food bars to pregnant or lactating women.
[0020] U.S. Pat. No. 4,038,423 discloses a food bar having a base
containing marshmallow fortified with a high protein ingredient of
reduced water binding capability, and a coating containing
fat-coated vitamins. This patent does not describe the use of
anti-constipation and regularity-maintaining agents or folic acid
in food bars, or the administration of food bars to pregnant or
lactating women.
[0021] U.S. Pat. No. 4,710,387 discloses a nutritional supplement
preparation (a powder material in Example 1, and a milk-like drink
in Example 2) for pregnant and breast-feeding women containing
10-20% by weight of protein, 16-28% by weight of fat, 43-65% by
weight of carbohydrates, 3.5% by weight of moisture, and one or
more minerals, trace elements and vitamins, such as calcium and
folic acid. This patent does not describe food bars, or the use of
anti-constipation and regularity-maintaining agents.
[0022] U.S. Pat. No. 4,751,085 discloses vitamin compositions
containing taurine (2-aminoethanesulfonic acid) provided either
alone or in food products, such as enriched breads, ready-to-eat
cereals and breakfast beverages. This patent does not describe food
bars.
[0023] U.S. Pat. No. 5,126,150 discloses a baked cookie containing
calcium lactate coated psyllium fiber, insoluble dietary fiber,
shortening, flour, sugar and water for use in the control of bowel
function (including as a laxative). This patent does not describe
food bars, the use of folic acid in food bars, or the
administration of food bars to pregnant or lactating women.
[0024] U.S. Pat. No. 5,494,678 discloses multi-vitamin and mineral
supplements for incorporation into tablets, powders, granules,
beads, lozenges, capsules and liquids, and administration to a
pregnant woman during her first, second and third trimesters of
pregnancy. The supplements contain specific regimens of a calcium
compound, vitamin D, folic acid, vitamin B.sub.12, vitamin B.sub.6,
and vitamin B.sub.1. This patent does not describe food bars or
anti-constipation and regularity-maintaining agents.
[0025] U.S. Pat. No. 5,571,441 discloses nutritional supplement
compositions containing vitamins, minerals, central nervous system
bracers, such as caffeine, and flavenols, that are coadministered
in the form of a tablet or capsule, as a powder, or as a liquid
form. This patent does not describe food bars or the administration
of vitamins or minerals to pregnant or lactating women.
[0026] U.S. Pat. Nos. 5,654,011 and 6,040,333 disclose vitamin- and
mineral-containing dietary supplements, including dietary bars, for
supplementing the dietary needs of women and preventing or reducing
life stage associated health risks during each of their principal
adult life stages (childbearing or pre-perimenopause, perimenopause
and menopause, or post-menopause). These patents do not describe
anti-constipation and regularity-maintaining agents.
[0027] U.S. Pat. No. 5,869,084 discloses multi-vitamin and mineral
supplements for administration to lactating, non-lactating (but not
pregnant) and menopausal women in the form of tablets, powders,
granules, beads, lozenges, capsules or liquids. This patent does
not disclose food bars, or the administration of vitamins or
minerals to pregnant women.
[0028] U.S. Pat. No. 5,906,833 discloses nutritional supplements,
including food bars, that contain vitamins. This patent does not
describe the use of folic acid or calcium in food bars,
anti-constipation and regularity-maintaining agents or the
administration of food bars to pregnant or lactating women.
[0029] U.S. Pat. No. 6,039,978 discloses a dietary food enhancement
agent for fortifying food products (meats, rolls, muffins, breads,
sauces, desserts, soups, potatoes, rice, cereals or fruit or
vegetable juice beverages). The agent contains a pre-mixed
combination of calcium, folic acid and other vitamins and minerals.
The nutritional enhancement is administered to a patient having at
least one dietary response condition, such as obesity,
hypertension, hyperlipidemia, cancer or diabetes. This patent does
not describe the administration of food bars to pregnant or
lactating women.
SUMMARY OF THE INVENTION
[0030] The present invention provides food bars for consumption by
pregnant women, lactating women, or women having childbearing
potential that are attempting to become pregnant containing one or
more vitamins and/or minerals and one or more anti-constipation and
regularity-maintaining agents. The food bars supplement the dietary
requirements of pregnant women, lactating women and women having
childbearing potential that are attempting to become pregnant. They
generally comprise one or more vitamins and/or minerals recommended
for consumption by pregnant women, lactating women or women having
childbearing potential that are attempting to become pregnant in an
amount that is effective for enhancing the nutrition of pregnant
women, lactating women, or women having childbearing potential that
are attempting to become pregnant, or of their developing fetuses
or babies, one or more anti-constipation and regularity-maintaining
agents in an amount that is effective for maintaining bowel
movement regularity and/or reducing or eliminating constipation,
from about 0 to about 99 weight percent of carbohydrates, from
about 0 to about 80 weight percent of proteins, and from about 0 to
about 60 weight percent of fats.
[0031] Vitamins, minerals and/or other nutritional supplements that
may be present in the food bars of the invention include protein,
Vitamin A, Vitamin B.sub.1, Vitamin B.sub.2, Vitamin B.sub.3,
Vitamin B.sub.6, Vitamin B.sub.9/M, Vitamin B.sub.12, Vitamin C,
Vitamin D, Vitamin E, Vitamin K Niacinamide, Tocopheryl, Calcium,
Iron, Phosphorus, Pantothenic Acid, Iodine, Magnesium, Biotin,
Folacin, Zinc, Selenium, Copper, Manganese, Chromium, Molybdenum,
Choline, Fluoride, Chloride, Potassium, Sodium, Docosahexaenoic
Acid (DHA) or Calcium Polycarbophil. The quantity of vitamins,
minerals and other nutritional supplements that is present in the
food bars of the invention is a quantity that is not harmful to
pregnant women, lactating women, or women having childbearing
potential that are attempting to become pregnant, or to their
developing fetuses or babies.
[0032] The food bars of the invention may readily be prepared in a
cost-effective manner using standard machinery and techniques, and
have a shelf life of approximately six to twenty-four months at
normal room temperature.
[0033] The present invention also provides methods for preparing
these food bars, and methods for supplementing the dietary
requirements of pregnant women, lactating women and/or women having
childbearing potential that are attempting to become pregnant.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] FIG. 1 is a schematic drawing showing one embodiment of the
process for preparing food bars according to the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] The present invention may be understood more readily by
reference to the following detailed description of the preferred
embodiments of the invention, and to the example included
therein.
[0036] Food Bars
[0037] In one aspect, the present invention provides food bars for
consumption by pregnant women, lactating women (women who are
secreting milk) or women having childbearing potential that are
attempting to become pregnant containing one or more vitamins,
minerals and/or other nutritional supplements recommended for
consumption by pregnant women, lactating women or women having
childbearing potential that are attempting to become pregnant and
one or more anti-constipation and regularity-maintaining agents.
Infertile women (women of childbearing age that have unsuccessfully
attempted to become pregnant for more than one year, but that have
the capacity to become pregnant) are one example of women having
childbearing potential that are attempting to become pregnant.
Other examples of such women include women of childbearing age that
have the ability to become pregnant, and that have unsuccessfully
attempted to become pregnant for one year or less, or that are
commencing their attempts to become pregnant.
[0038] The food bars of the invention contain the ingredients, and
amounts thereof, described hereinbelow.
[0039] The food bars of the invention generally comprise one or
more vitamins and/or minerals recommended for consumption by
pregnant women, lactating women or women having childbearing
potential that are attempting to become pregnant in an amount that
is effective for enhancing the nutrition of pregnant women,
lactating women or women having childbearing potential that are
attempting to become pregnant, or of their developing fetuses or
babies, and that is not harmful to developing fetuses or
breast-feeding babies, one or more anti-constipation and
regularity-maintaining agents in an amount that is effective for
maintaining regular bowel movements and/or reducing or eliminating
constipation, and that is not harmful to developing fetuses or
breast-feeding babies, from about 0 to about 99 weight percent of
carbohydrates, from about 0 to about 80 weight percent of proteins,
and from about 0 to about 60 weight percent of fats.
Vitamins and Minerals
[0040] A wide variety of vitamins and minerals that are safe for
consumption by pregnant women, lactating women or women having
childbearing potential that are attempting to become pregnant may
be used in the food bars of the invention in varying quantities.
These vitamins and minerals include, for example, Vitamin A,
Vitamin B.sub.1 (as Thiamin or Thiamine Mononitrate), Vitamin
B.sub.2 (as Riboflavin), Vitamin B.sub.3 (as Niacin), Vitamin
B.sub.6 (as Pyridoxine or Pyridoxine Hydrochloride), Vitamin
B.sub.9/M (Folic Acid), Vitamin B.sub.12 (cyanocobalamine), Biotin,
Vitamin C (Ascorbic Acid), Vitamin D, Vitamin E (as dl-Alpha
Acetate or d-alpha Nat'l), Vitamin K, Folacin, Niacinamide,
Tocopheryl, Calcium (as Calcium Carbonate), Iron (as Ferrous
Fumarate), Phosphorus, Pantothenic Acid (as Calcium Pantothenate),
Iodine (as Potassium Iodide), Magnesium (as Magnesium Oxide), Zinc
(as Zinc Oxide), Selenium (as Sodium Selenate), Copper (as Cupric
Oxide), Manganese (as Manganese Sulfate), Chromium (as Chromium
Chloride), Molybdenum (as Sodium Molybdate), Choline, Fluoride,
Chloride, Potassium, Sodium, and mixtures thereof. Such vitamins
and minerals are commercially available from sources known by those
of skill in the art, such as Hoffinann-LaRoche Inc. (Nutley,
N.J.).
[0041] Pre-mixes containing vitamins and minerals recommended for
pregnant women, lactating women and women having childbearing
potential that are attempting to become pregnant that may be
employed to produce the food bars of the present invention may be
obtained from Watson Foods Co., Inc. under Watson Code WT-6061A.
One of these pre-mixes contains the nutrients set forth below.
3 Nutrient Per 6,000 mg Vitamin A (Vitamin A Palmitate) 2500 I.U.
Vitamin A (Beta Carotene) 2500 I.U. Thiamin (Thiamin Mononitrate) 3
mg Riboflavin 3.4 mg Niacin (Niacinamide) 20 mg Pyridoxine
(Pyridoxine Hydrochloride) 10 mg Folic Acid 1 mg Vitamin B.sub.12
(Cyanocobalamine) 0.012 mg Biotin 0.3 mg Vitamin C (Ascorbic Acid)
120 mg Vitamin D (Cholecalciferol) 400 I.U. Vitamin B (d,l Alpha
Tocopheryl Acetate) 30 I.U. Calcium (Dicalcium Phosphate, Calcium
Carbonate) 1200 mg Iron (Ferrous Fumarate) 27 mg Pantothenic Acid
(d-Calcium Pantothenate) 10 mg Iodine (Potassium Iodide) 0.15 mg
Magnesium (Magnesium Oxide) 400 mg Zinc (Zinc Oxide) 25 mg Selenium
(Sodium Selenate) 0.07 mg Copper (Cupric Oxide) 2 mg Manganese
(Manganese Sulfate) 5 mg Chromium (Chromium Chloride) 0.125 mg
Molybdenum (Sodium Molybdate) 0.0750 mg Maltodextrin, QS to make
6,000 mg
[0042] The food bars of the invention may be formulated using any
pharmaceutically-acceptable forms of the vitamins and/or minerals
described above, including their salts, which are known by those of
skill in the art. For example, useful pharmaceutically-acceptable
calcium compounds include any of the well-known calcium
supplements, such as Calcium Carbonate, Calcium Sulfate, Calcium
Oxide, Calcium Hydroxide, Calcium Apatite, Calcium Citrate-Malate,
Bone Meal, Oyster Shell, Calcium Gluconate, Calcium Lactate,
Calcium Phosphate, Calcium Levulinate, and the like. An instantly
soluble calcium preparation that is composed of organic calcium
salts, that is suitable for mineral fortification of food products,
and that is known as Instant Calcium, is available from
Flavor-Savor, Inc. (Franklin Park, IL). This product is generally
odorless, tasteless and colorless when dissolved in either cold or
hot water, and provides about 10% of the calcium Recommended Daily
Allowance per 1 gram. Pharmaceutically-acceptable magnesium
compounds include Magnesium Stearate, Magnesium Carbonate,
Magnesium Oxide, Magnesium Hydroxide and Magnesium Sulfate.
Pharmaceutically-acceptable iron compounds include any of the
well-known Iron II (ferrous) or Iron III (ferric) supplements, such
as Ferrous Sulfate, Ferric Chloride, Ferrous Gluconate, Ferrous
Lactate, Ferrous Tartrate, Iron-Sugar-Carboxylate complexes,
Ferrous Fumarate, Ferrous Succinate, Ferrous Glutamate, Ferrous
Citrate, Ferrous Pyrophosphate, Ferrous Cholinisocitrate, Ferrous
Carbonate, and the like.
[0043] The vitamins and/or minerals used to prepare the food bars
of the invention may be microencapsulated in a coating of fat,
microcrystalline cellulose or similar material in order to prevent
their degradation under various conditions.
[0044] The vitamins and/or minerals that are employed in the food
bars of the invention are those that are recommended for
consumption by pregnant women, lactating women or women having
childbearing potential that are attempting to become pregnant.
These vitamins and minerals are employed in an amount that is
effective for enhancing the nutrition of pregnant women, lactating
women or women having childbearing potential that are attempting to
become pregnant, or of their developing fetuses or babies. This
quantity will vary depending upon the particular vitamins and/or
minerals chosen for use, but generally ranges from about 2.5 to
about 50 weight percent of the total weight of the food bars, and
preferably ranges from about 5 to about 25 weight percent, with
about 10 weight percent being most preferred. Low- or high-iron or
low- or high-calcium (as those terms are defined in the art) food
bars may be prepared in accordance with the present invention.
[0045] Each food bar may contain one or more of the above vitamins
and/or minerals in any quantity that is safe for consumption by
pregnant women, lactating women or women having childbearing
potential that are attempting to become pregnant (i.e., a quantity
that would not cause harm to the woman consuming the food bar, or
to her developing fetus or breast-feeding baby). Set forth
hereinbelow are the approximate preferred ranges of the daily
quantities of the various vitamins and minerals that may generally
be used in one food bar (or divided between more than one food bar
for consumption during a one-day period) for pregnant women,
lactating women or women having childbearing potential that are
attempting to become pregnant (from about one quantity to about
another quantity), as well as more preferred ranges, and the most
preferred quantities.
4 Most Preferred Most Preferred More Quantity Quantity for
Preferred Preferred for Pregnant Lactating Range Range Women Women
Vitamin Vitamin A 0-9,000 I.U. 1,000-7,000 I.U. 5,000 I.U. 7,000
I.U. Vitamin B.sub.1 0-50 mg 1.4-10 mg 3 mg 3.2 mg (Thiamin)
Vitamin B.sub.2 0-50 mg 1.6-25 mg 3.4 mg 3.9 mg (Riboflavin)
Vitamin B.sub.3 0-60 mg 17-40 mg 20 mg 24 mg (Niacin) Vitamin
B.sub.6 0-50 mg 2.2-40 mg 10 mg 9.5 mg (Pyridoxine) Vitamin
B.sub.9/M 0-2,000 mcg 400-1,000 mcg 1,000 mcg 400 mcg (Folic Acid)
Vitamin B.sub.12 0-1,000 mcg 2.6-18 mcg 12 mcg 14 mcg
(cyanocobalamine) Biotin 0-600 mcg 30-400 mcg 30 mcg 35 mcg Vitamin
C 0-1,000 mg 80-500 mg 120 mg 163 mg Vitamin D 0-800 I.U. 200-400
I.U. 400 I.U. 400 I.U. Vitamin E 0-1,500 I.U. 10-400 I.U. 30 I.U.
36 I.U. Vitamin K 0-80 mcg 10-65 mcg 10 mcg 10 mcg Mineral Calcium
0-3,000 mg 200-2,000 mg 1,300 mg 1,300 mg Iron 0-100 mg 18-90 mg 27
mg 27 mg Phosphorus 0-2,000 mg 100-1,250 mg 100 mg 100 mg
Pantothenic Acid 0-20 mg 6-15 mg 10 mg 10 mg Iodine 0-200 mcg
175-200 mcg 175 mcg 200 mcg Magnesium 0-600 mg 200-500 mg 400 mg
360 mg Zinc 0-30 mg 1-25 mg 10 mg 10 mg Selenium 0-400 mcg 60-100
mcg 60 mcg 70 mcg Copper 0-2 mg 0.1-2 mg 2 mg 2 mg Manganese 0-5 mg
0.1-5 mg 5 mg 5 mg Chromium 0-150 mcg 0.1-120 mcg 25 mcg 25 mcg
Molybdenum 0-75 mcg 0.1-50 mcg 25 mcg 25 mcg Choline 0-1,000 mg
300-600 mg 450 mg 550 mg Fluoride 0-5 mg 1-4 mg Not Established Not
Established Chloride 0-3,400 mg 10-1,000 mg Not Established Not
Established Potassium 0-80 mg 10-80 mg Not Established Not
Established Sodium 0-2,400 mg 10-1,000 mg Not Established Not
Established
[0046] One food bar may contain each of the above vitamins and
minerals in their preferred quantity range (or in their more
preferred range, or in the most preferred quantity for pregnant
women, lactating women or women having childbearing potential that
are attempting to become pregnant). Alternatively, one food bar may
contain each of these vitamins and/or minerals in one half, one
third, one forth, one fifth, one sixth, and so forth, of these
quantities. Varying combinations of the vitamins and minerals may
also be employed. It is important that the quantity of each vitamin
and mineral used in a food bar is safe for consumption by pregnant
women, lactating women or women having childbearing potential that
are attempting to become pregnant, and is safe for their developing
fetuses or babies. Larger quantities of certain vitamins or
minerals may cause damage to a developing fetus or baby. Those of
skill in the art know the quantities of vitamins and minerals above
the Recommended Dietary Allowance, Estimated Safe and Adequate
Daily Dietary Intakes or U.S. Recommended Daily Allowance for
pregnant women, lactating women or women having childbearing
potential that are attempting to become pregnant that would be
harmful for the women consuming the food bars, or for their
developing fetuses or babies.
Anti-Constipation and Regularity-Maintaining Agents
[0047] A wide variety of anti-constipation and
regularity-maintaining agents may also be used in the food bars of
the present invention in varying quantities. As used herein, the
phrase "anti-constipation and regularity-maintaining agent" means
any naturally-occurring substance, chemical, medicine, food
component, food, or other substance, whether natural, by
prescription or over-the-counter, that will not cause any harm to
pregnant women, lactating women or women having childbearing
potential that are attempting to become pregnant, or to their
developing fetuses or breast-feeding babies, and aids in
maintaining regular bowel movements and/or reduces or eliminates
constipation (infrequent or difficult bowel movements). Generally,
bowel movements are considered to be regular when they occur once
or more every three days, and preferably once or more every two
days, and more preferably once or more every day. However, the
regularity of bowel movements differs for different individuals.
Bowel movements that may be considered regular by one individual
may not be considered regular by another individual.
Anti-constipation and regularity-maintaining agents often increase
the bulk or water content of stools, making bowel movements more
regular and/or comfortable. The anti-constipation and
regularity-maintaining agents may be bulk-forming ingredients
(ingredients that increase the bulk volume and water content of the
stool, thereby promoting bowel movements) or laxative
ingredients.
[0048] Some of the known naturally-occurring, chemical, medicinal,
prescription or over-the-counter agents for maintaining regularity
and/or reducing or eliminating constipation include, for example,
agar, alpha cellulose, linseed (whole, crushed or rough ground),
psyllium, psyllium seed, psyllium seed (blond), psyllium seed husk,
psyllium hydrophilic mucilloid, calcium lactate coated psyllium,
kelp, Plantago ovata husks, polycarbophil, calcium polycarbophil,
linolenic acid, carrageenan (degraded or native), guar gum, malt
soup extract, karaya, methylcellulose, carboxymethylcellulose,
sodium carboxymethylcellulose, docusate sodium, bran (wheat, corn,
barley, rye, oats, cereal or other grain products, particularly in
whole form), flax, flaxseed (whole, crushed or rough ground),
flaxseed oil, beans, nuts, seeds, fruit (particularly when the skin
is present), pectin, vegetables (particularly raw, and when the
skin is present), diphenylmethane derivatives, such as
phenolphthalein and bisacodyl, saline and osmotic laxatives
(various Mg.sup.2.sup.+ salts, such as magnesium sulfate, magnesium
citrate, and magnesium hydroxide, the sulfate, phosphate and
tartrate salts of Na.sup.+ or K.sup.+, such as sodium phosphate,
sodium biphosphate, sodium sulfate, sodium bicarbonate, sodium
chloride, potassium chloride, potassium sodium tartrate, and
tartaric acid and its salts), castor oil, mineral oil, the
dissacharides lactulose, glycerin and sorbitol, and other forms of
soluble and insoluble fiber, all of which are commercially
available from sources known in the art, and mixtures thereof.
Calcium polycarbophyll, psyllium, methylcellulose and bran are
preferred anti-constipation and regularity-maintaining agents for
use in the food bars of the invention.
[0049] Some fiber is soluble in water, and other fiber is
insoluble. Insoluble fiber is indigestible, and passes through the
body virtually intact. It aids digestion, adds bulk to stools, and
hastens the passage of fecal material through the abdomen, thus,
helping to prevent or alleviate constipation, and related
hemorrhoids. Foods containing high levels of soluble fiber are
dried beans, oats, barley and some fruits, such as apples and
citrus, and vegetables, such as potatoes. Foods high in insoluble
fiber are wheat bran, whole grains, cereals, seeds and the skins of
many fruits and vegetables.
[0050] Psyllium fiber is the coat of the psyllium seed (either
intact or comminuted), which come from plants of the Plantago
genus. The seed coats can be removed and sanitized by methods known
in the art, such as ethylene oxide sanitation or steam sanitation,
as described in U.S. Pat. No. 4,911,889.
[0051] Additional information concerning agents used to maintain
regularity of bowel movements and/or to reduce or eliminate
constipation is present in The Merck Index (Eleventh Edition, Merck
& Co., Inc., Rahway, N.J., 1989), in Goodman and Gilman's The
Pharmacological Basis of Therapeutics (Eight Edition, Pergamon
Press, New York, 1990), in J. O. Greenhalf, "Laxatives in the
Treatment of Constipation in Pregnant and Breast-Feeding Mothers,"
The Practitioner, 210, 259-263 (1973), and in 21 CFR Part 334
("Laxative Drug Products for Over-the-Counter Human Use").
[0052] The anti-constipation and regularity-maintaining agents are
employed in the food bars of the invention in an amount that is
effective for maintaining regular bowel movements and/or reducing
or eliminating constipation. This quantity will vary depending upon
the particular anti-constipation and regularity-maintaining agent
used, but generally ranges from about 0.1 to about 80 weight
percent of the total weight of the food bars, and preferably ranges
from about 1 to about 60 weight percent, with about 2 weight
percent being most preferred for polycarbophyll and about 33 weight
percent being most preferred for bran.
[0053] A typical dose of psyllium for Taxation purposes involves
the administration of from about 3 to about 15 grams of psyllium
fiber in one dose. Calcium polycarbophyll is generally administered
to pregnant women, lactating women or women having childbearing
potential that are attempting to become pregnant in a daily amount
ranging from about 1 to about 5,000 mg, preferably ranging from
about 1,250 to about 5,000 mg, with about 1,250 mg being most
preferred (for each category of women). Flax is generally
administered to pregnant women, lactating women or women having
childbearing potential that are attempting to become pregnant in a
daily amount ranging from about 1 to about 5,000 mg, preferably
ranging from about 1,000 to about 3,000 mg, with about 1,000 mg
being most preferred (for each category of women). Linolenic acid
is generally administered to pregnant women, lactating women or
women having childbearing potential that are attempting to become
pregnant in a daily amount ranging from about 1 to about 300 mg,
preferably ranging from about 10 to about 200 mg, with about 100 mg
being most preferred (for each category of women).
[0054] Constipation may be a sign of a serious condition that
requires the diagnosis and treatment by a physician. Constipation
lasting longer than one week could signify a more serious
condition, such as deverticular disease of the colon, irritable
bowel, or cancer of the colon. In such cases, the individuals
suffering from constipation should visit a physician at the
earliest possible time so that the condition can be diagnosed and
properly treated.
Carbohydrates
[0055] A wide variety of carbohydrates can be employed to produce
the food bars of the invention. These carbohydrates include any
carbohydrates that are customary in the preparation of foods, such
as ingestible monossaccharidic or dissaccharidic materials, their
hydrolysis products, and mixtures thereof, for example, dextrose
(glucose), sucrose, fructose, lactose, maltose, galactose, sugar
alcohols, such as sorbitol, mannitol and xylitol, invert sugar
syrups, brown sugar, corn syrup, corn syrup solids, honey,
molasses, maple syrup, and the like, which are commercially
available from sources known by those of skill in the art, and
mixtures thereof. Molasses, corn syrup, brown sugar and dextrose
are preferred carbohydrates for use in the food bars of the
invention.
[0056] The carbohydrates employed to produce the food bars of the
invention generally range from about 0 to about 99 weight percent
of the total weight of the food bars, and preferably range from
about 1 to about 60 weight percent, with about 40 weight percent
being most preferred (for pregnant women, lactating women and women
having childbearing potential that are attempting to become
pregnant). Low- or no-sugar food bars (as these terms are defined
in the art) may be produced in accordance with the present
invention.
Proteins
[0057] A wide variety of edible proteins may be employed to produce
the food bars of the invention. These proteins include, for
example, cereal proteins, milk proteins, egg proteins, animal
proteins, vegetable proteins, whey protein, bean proteins,
lactalbumin-casein coprecipitate, calcium caseinate, sodium
caseinate, purified or refined grades of casein and soy proteins,
peanuts, which are commercially available from sources known by
those of skill in the art, and mixtures thereof. Whey protein and
soy protein are the preferred proteins for use in the food bars of
the invention.
[0058] The proteins employed to produce the food bars of the
invention generally range from about 0 to about 80 weight percent
of the total weight of the food bars, and preferably range from
about 20 to about 60 weight percent, with about 40 being most
preferred (for pregnant women, lactating women and women having
childbearing potential that are attempting to become pregnant).
Low-, no- or high-protein food bars (as these terms are defined in
the art) may be produced in accordance with the present
invention.
Fats
[0059] A wide variety of fats can be employed to produce the food
bars of the invention. These fats include, for example, olive oil,
canola oil, palm oil, coconut oil, sunflower oil, peanut oil,
vegetable oil, lecithin, fish oil, cotton seed oil, soybean oil,
lard, DHA, monoglycerides, diglycerides, butter, margarine, and
other animal, vegetable, and marine fats, and milk fats, which are
commercially available from sources known by those of skill in the
art, and mixtures thereof. Vegetable oil is the preferred fat for
use in the food bars of the invention.
[0060] The fats employed in the food bars of the invention
generally range from about 0 to about 60 weight percent of the
total weight of the food bars, and preferably range from about 1 to
about 40 weight percent, with about 20 weight percent being most
preferred (for pregnant women, lactating women and women having
childbearing potential that are attempting to become pregnant).
Low- or no-fat food bars (as these terms are defined in the art)
may be produced in accordance with the present invention.
[0061] In order to obtain a good fat distribution within the
mixture of ingredients used to form the food bars of the invention,
fats that are solid at room temperature may be heated to a
temperature ranging from about 100.degree. F. to about 220.degree.
F., and preferably to a temperature ranging from about 160.degree.
F. to about 172.degree. F. If the solid fat is not heated enough,
it will not melt and, thus, will not mix easily with the other
ingredients. However, in order to minimize off-flavors that may
result from heating solid fats too long, or at too high of a
temperature, or the degrading of vitamins that are mixed with the
fats, solid fats should generally only be heated for a period of
time, and at a temperature, that is sufficient to transform the
solid fats into a liquid or semi-liquid state, and to allow the
fats to properly blend with other ingredients.
Water
[0062] The amount of water employed to make the food bars of the
invention generally ranges from about 0 to about 33 weight percent
of the total weight of the food bars, and preferably ranges from
about 0 to about 6 weight percent, with about 0 weight percent
being most preferred. Water may be employed, for example, to
dissolve a vitamin pre-mix that will be used to prepare food bars
of the invention. When the food bars of the invention are prepared
by baking, the dough from which the food bars are produced contains
substantially more water than the final products, which are baked.
This is not the case when the food bars are fully or partially cold
formed (as defined hereinbelow).
[0063] The temperature of the water employed to produce the food
bars of the invention generally should be no higher than about
130.degree. F. In addition, the water used should be in a liquid
state (i.e., not frozen). Thus, the temperature of the water
employed in the process of the invention should generally range
from about ambient temperature to about 130.degree. F., with
ambient temperature being most preferred.
Preservatives
[0064] One or more preservatives, such as sodium benzolate,
ascorbyl palmitate, sorbic acid, BHT or EDTA may, optionally, be
employed in the food bars of present invention, for example, to
increase the shelf life of the final products. The preservatives
employed in the food bars of the invention generally range from
about 0 to about 5 weight percent of the total weight of the food
bars, and preferably range from about 1 to about 3 weight percent,
with about 1 weight percent being most preferred (for pregnant
women, lactating women and women having childbearing potential that
are attempting to become pregnant).
[0065] Sodium benzolate is a preservative that prevents the
oxidation, chelation or hydrolysis of the ingredients contained in
the food bars of the invention and, thus, diminishes the capacity
of the food bars to lose vitamin or mineral potency, or to develop
off flavors.
BITTERNESS AND OFF-TASTE MASKING AGENTS
[0066] Agents that mask the bitterness or off taste of other
ingredients that may be present in the food bars of the invention,
such as vitamins and/or minerals (particularly the B vitamins,
which have strong aromas and tastes, minerals, which often have
unpleasant metallic tastes, and herbs and botanicals, such as Kava
Kava and Ginko Biloba, which have strong bitter tastes), and that
are safe for pregnant or lactating women, and their developing
fetuses or babies, may, optionally, be employed in the food bars of
present invention. A wide range of bitterness and off-taste masking
agents in various forms (liquid, powder or solid) that may be
employed in the food bars of the invention may be obtained from
sources known by those of skill in the art, such as Flavor Savor,
Inc. (Franklin Park, Ill.). Some of the agents that are available
from Flavor Savor, Inc., include No. 598.605/T, No. 597.492/A, No.
598.876/TP05.51, No. 598.118/AP10.51, No. 861.016/TD10.90 and
No.861.472/TD10.90.
[0067] The bitterness and off-taste masking agents employed in the
food bars of the invention generally range from about 0 to about 3
weight percent of the total weight of the food bars, and preferably
range from about 0.05 to about 2 weight percent, with about 0.5
weight percent being most preferred (for pregnant women, lactating
women and women having childbearing potential that are attempting
to become pregnant). It is preferable that a 60 g food bar of the
invention contain about 1,250 mg of a bitterness or off-taste
masking agent.
Binders
[0068] Binders that are safe for consumption by pregnant women,
lactating women and women having childbearing potential that are
attempting to become pregnant, such as polyvinyl alcohol or
methylcellulose may, optionally, be employed in the food bars of
present invention to ensure a uniform consistency of the food bars.
The binders employed in the food bars of the invention generally
range from about 0 to about 10 weight percent of the total weight
of the food bars, and preferably range from about 1 to about 7
weight percent, with about 1 weight percent being most preferred
(for all three categories of women). It is preferable that a 60 g
food bar of the invention contain about 1,250 mg of a binder.
Other Optional Ingredients
[0069] It is contemplated that a wide variety of other edible
natural or artificial flavors and ingredients may, optionally, be
employed to produce the food bars of the invention. Such
ingredients include any edible substance that would not endanger
the health of the pregnant women, lactating women or women having
childbearing potential that are attempting to become pregnant
consuming the food bars, or the health of the developing fetuses or
babies, and which either alone, or in combination with other
ingredients, imparts a desirable taste, color, nutritional and/or
other benefit to the food bars being manufactured. The amount and
type of these ingredients that may be employed to produce the food
bars of the invention depend upon the desired color, flavor,
nutritional content or other benefit of the final food bars being
produced. Examples of optional ingredients that may be incorporated
into the food bars of the invention include, for example, vanilla
or cocoa liquor, cocoa powder, mocha, artificial flavors, various
fruit flavors, such as strawberry, lemon, orange, grape or
pineapple, or any such flavor as is normally used in food products,
caramel, yogurt, whole milk, skim milk, buttermilk, concentrated
milk products (condensed or evaporated milk), dried milk products,
nonfat milk powder, dry whole milk, modified whole milk, egg
products, including egg whites and egg yolks, flour ingredients,
such as wheat flour, rye flour, corn flour, cottonseed meal or
sorghum flour, in either bleached or unbleached form, spices, such
as cinnamon or nutmeg, salt, antioxidants, nuts, granola (whole
grain rolled oats, rolled whole wheat, sugar, partially
hydrogenated soybean and/or cottonseed oil, whole wheat flour,
molasses, honey, cultured whey, soy lecithin and natural flavor),
any of the components of granola, cereal, oats, wheat, corn, rice,
rice crisp, soy, herbs, such as Ginko or Echinacea, sodium
benzolate, DHA, para-aminobenzoic acid, inositol, lutein, vanadium,
boron, nickel, silicon, tin, phytochemicals, isoflavonoids, omega 3
and 6 fatty acids, essential and non-essential amino acids,
bioflavonoids, such as quercetin and rutin NF, emulsifiers, citric
acid, artificial sweeteners (aspartame, acesulfame, saccharin,
cyclamate), and pieces of commercially-available candy bars. All of
these optional ingredients are commercially available from sources
known by those of skill in the art.
[0070] DHA (docosahexaenoic acid) is a long-chain fatty acid that
is necessary for brain and eye development in children, and may be
included as an ingredient of the food bars of the invention in an
amount ranging from about 0 to about 1,000 mg, with about 200 to
600 mg being preferred, and about 300 mg being most preferred (for
pregnant women, lactating women, and women having childbearing
potential that are attempting to become pregnant).
[0071] The most preferred quantity for use in the food bars of the
invention for pregnant women, lactating women and women having
childbearing potential that are attempting to become pregnant of
para-aminobenzoic acid is 15 mg, of inositol is 10 mcg, of lutein
is 250 mcg, of vanadium is 10 mcg, of boron is 150 mcg, of nickel
is 5 mcg, of silicon is 2 mg and of tin is 10 mcg.
[0072] If a flour component is employed to produce the food bars of
the invention, such flour component will generally range from about
0 to about 90 weight percent of the total weight of the food bars,
and preferably ranges from about 0 to about 45 weight percent, with
about 0 to about 30 weight percent being most preferred.
[0073] Method of Production
[0074] In another aspect, the present invention provides a method
for preparing food bars for consumption by pregnant women,
lactating women and women having childbearing potential that are
attempting to become pregnant that contain one or more vitamins
and/or minerals and one or more anti-constipation and
regularity-maintaining agents. Although the food bars of the
invention may be prepared according to any procedure known in the
art for preparing food bars, it is preferred that the food bars be
fully cold-formed (be prepared without the use of any heat) or
partially cold-formed (be prepared using one or more heating steps,
such as using a jacketed kettle, but without the use of any baking
steps).
[0075] FIG. 1. depicts a preferred embodiment of a process for
preparing the food bars in accordance with the present invention.
Referring to FIG. 1, separately, a binder for the base of the food
bars is produced 10, the base of the food bars is produced 12, and
a top layer for the food bars is produced 14. The base of the food
bars is then extruded 16 to produce bars of the desired shape and
size. A top layer is then placed on top of each of the extruded
bars 18, and the resulting bars are coated on the top, bottom and
all sides with an outside coating 20. The resulting food bars of
the invention are then packaged 22.
Production of Binder for Base of Food Bars
[0076] Oil-soluble vitamins and/or minerals, such as Vitamin A,
Vitamin D and Vitamin E, are preferably dissolved in a fat, such as
sunflower oil, that has been heated to a temperature ranging from
about 160.degree. F. to about 180.degree. F., and preferably about
172.degree. F. Any convenient piece of equipment, such as a stove
top, may be used to heat the fat. If the fat is a solid, and it is
not heated enough, the fat will not properly blend with the
oil-soluble vitamins. However, it the fat is heated too much, the
heat will degrade the vitamins being dissolved therein. The
vitamins are mixed with the fat until a uniform blend of the fat
and vitamins is achieved, which generally takes from about 10 to
about 30 minutes, and depends upon the size and speed of the
blender being employed. Also, some oil-soluble vitamins dissolve
more slowly than others. Any conventional piece of equipment for
blending ingredients together may be used to blend the fat with the
oil-soluble vitamins. In order to prevent the heat from degrading
the vitamins, the uniform blend of oil-soluble vitamins and fat
should then be cooled to a temperature ranging from about
135.degree. F. to about 150.degree. F., and preferably to about
142.degree. F. Any convenient method for cooling may be employed.
If the uniform blend is cooled too much, it will solidify and,
thus, will not mix well with other ingredients used to prepare the
food bars.
Production of Base of Food Bars
[0077] Crisp rice (or other similar materials, such as granola or
cracked wheat) is preferably blended with an anti-constipation and
regularity-maintaining agent, such as calcium polycarbophyll, until
a uniform blend of the ingredients is achieved without breaking the
crisp rice down. This generally takes from about 5 to about 60
minutes, and depends upon the size and speed of the blender being
employed. Overmixing of the crisp rice with the anti-constipation
and regularity-maintaining agent will result in the breaking down
of the crisp rice, which is not desirable. Any conventional piece
of equipment for blending ingredients together may be used to blend
the crisp rice with the anti-constipation and
regularity-maintaining agent, such as a day mixer. The amount of
crisp rice (or other similar materials) that should be used is an
amount that will, when blended with other ingredients employed to
form the base of the food bars, permit the formation of a food bar
base having a consistency that may be readily extruded into bars of
a desired shape and size. A person of skill in the art may readily
determine this amount.
[0078] The binder for the base of the food bars should then be
slowly added to the blender, while mixing is occurring. Mixing
should continue until another uniform blend is achieved. This will
generally take from about 5 to about 60 minutes, depending upon the
size and speed of the blender being employed. The resulting mixture
should then be cooled to a temperature ranging from about
135.degree. F. to about 150.degree. F., and preferably to about
142.degree. F. Any convenient method for cooling may be
employed.
Production of Top Layer of Food Bars
[0079] A top layer, which is preferably a caramel blend, is
preferably prepared for placement onto the top of the base of the
food bars. Preferably, a milk source (preferably from about 5 to
about 20 weight percent of the food bars), such as liquid skim
milk, is mixed with a sweetener (preferably from about 40 to about
70 weight percent of the food bars), such as liquid sucrose and/or
corn syrup, a fat, such as palmolein oil (preferably from about 5
to about 20 weight percent of the food bars), and one or more
flavor ingredients (preferably from about 0.5 to about 2 weight
percent of the food bars) while the mixture is heated to a
temperature ranging from about 220.degree. F. to about 260.degree.
F., and preferably about 240.degree. F., in, for example, a
conventional, fixed-speed jacketed kettle that has a high shear
mixer and sweep agitator with side wall scrapers placed therein.
The mixture should be heated and stirred until the solids content
of the mixture becomes between about 85% and about 92%, preferably
about 90.5%. The mixture is then cooled to a temperature ranging
from about 135.degree. F. to about 150.degree. F., and preferably
to about 142.degree. F., a temperature which will allow the mixture
to be pourable (not solid), but which is not so high that it will
degrade vitamins being mixed therewith. Any convenient method for
cooling may be employed.
[0080] Water-soluble vitamins and/or minerals, such as Vitamin C,
Calcium and Iron, are then added to the cooled mixture, and the
ingredients are mixed until a uniform blend of the ingredients is
achieved, which generally takes from about 10 to about 60 minutes,
and depends upon the size and speed of the blender being employed.
The resulting uniform blend is then maintained at a temperature
ranging from about 135.degree. F. to about 150.degree. F., and
preferably about 140.degree. F.
Extrusion
[0081] The base of the food bars is then extruded to form
individual bars of the desired shape and size. The product may be
extruded with any suitable extruding apparatus known by those of
skill in the art. However, it is preferred that the product be
extruded with an NID Extruder.
Placement of Top Layer onto Resulting Bars
[0082] The top layer of the food bars is then preferably placed
into a hopper of a top-coating machine. The individual bars that
have been extruded are then preferably passed through the top
coating machine, and a desired quantity of the top layer, which
generally ranges from about 5 to about 50 weight percent of the
food bars, with about 20 weight percent being preferred, is
dispensed onto the top of each bar by the top coating machine. The
resulting bars are then cooled to a temperature ranging from about
50.degree. F. to about 90.degree. F., and preferably about
85.degree. F. Any convenient method for cooling may be
employed.
Placement of Outside Coating over Resulting Bars
[0083] A commercially-available chocolate coating, preferably an
artificial chocolate confectioners coating (Kraft Foods, Inc.,
Northfield, Ill.), is preferably placed into the hopper of a
cascading coating machine, and is allowed to recirculate for
several minutes, such as twenty minutes. The bars that have had a
top coating placed on the top thereof are preferably then passed
through the coating machine, and a desired quantity of the
chocolate coating, which generally ranges from about 5 to about 30
weight percent of the food bars, with about 15 weight percent being
preferred, is placed upon the top, bottom and sides of each bar.
The resulting food bars are then cooled to a temperature ranging
from about 50.degree. F. to about 75.degree. F., and preferably
about 60.degree. F. Any convenient method for cooling, such as
passing the bars through a cooling tunnel, may be employed. It is
preferable that food bars that have been coated with real chocolate
be cooled to a temperature well below the melting point of real
chocolate (about 110.degree. F.), and that food bars that have been
coated with an artificial chocolate confectioners coating be cooled
to a temperature well below the melting point of the artificial
chocolate confectioners coating (about 125.degree. F.).
Irradiation
[0084] Prior to packaging the food bars of the invention, the food
bars may, optionally, be irradiated in order to kill microorganisms
that may have contaminated the food bars during their preparation.
Such irradiation should not diminish the effectiveness of the
vitamins, minerals or anti-constipation and regularity-maintaining
agents contained therein.
Packaging
[0085] The resulting food bars may then be packaged in any manner
known by those of skill in the art for packaging food bars. The
preferred method of packing the food bars is by hermetically
sealing each food bar within a film having oxygen barrier
properties, such as a foil laminate, purging the inner space of the
wrapper with nitrogen (to create a nitrogen blanket), placing a
group of the wrapped food bars in an aluminum can, having the air
present in the aluminum can removed with a vacuum, and replacing
the removed air with nitrogen. When packaged in this manner, the
food bars of the invention have a shelf life at normal room
temperature (from about 59.degree. F. to about 86.degree. F.) of
about two years. However, food bars of the invention that have
chocolate coatings made from real chocolate should be
refrigerated.
Composition of Final Product
[0086] The food bars of the invention may be in one unit (i.e.,
they will not contain a series of layers), or they may contain a
series of two, three, four, five, six or more layers.
[0087] The food bars of the invention may be made of any desirable
weight, but will generally range in weight from about 5 to about
100 g, and will preferably range in weight from about 10 to about
60 g, with about 50 g being most preferred (for pregnant women,
lactating women and women having childbearing potential that are
attempting to become pregnant).
[0088] The food bars of the invention may be of any desirable
shape, such as circular, oval, rectangular, square, triangular,
round, flat or cylindrical. However, they are preferably
rectangular. They may be of any desirable size, but will generally
range in size from about 0.5 to about 12 inches in length, from
about 0.5 to about 12 inches in width and about 0.2 to about 4
inches in thickness, and preferably range in size from about 1 to
about 6 inches in length, from about 0.5 to about 2 inches in width
and from about 0.2 to about 2 inches in thickness, with about 4.75
inches in length, about 1.5 inches in width and about 0.625 inches
in thickness being most preferred. The food bars are preferably of
such dimensions that one serving of one bar provides all of the
daily requirements for a pregnant woman, a lactating woman or a
woman having childbearing potential that is attempting to become
pregnant of vitamins, minerals and other nutrients, and a
sufficient amount of an anti-constipation and
regularity-maintaining agent to permit these women to have more
regular and comfortable bowel movements. However, such nutrients
and anti-constipation and regularity-maintaining agents may be
distributed throughout a series of two, three, four, five, six or
more bars to be consumed per day by such women. In addition, the
food bars can have a frangibly segmented structure. The segments
can be formed by indentations, perforations or the like, which
serve to differentiate separate parts or subgroups of parts from
one another.
[0089] The carbohydrate content of the food bars of the invention
generally ranges from about 0 to about 99 weight percent of the
total weight of the food bars, and preferably ranges from about 1
to about 60 weight percent, with about 40 weight percent being most
preferred (for pregnant women, lactating women and women having
childbearing potential that are attempting to become pregnant).
[0090] The protein content of the food bars of the invention
generally ranges from about 0 to about 80 weight percent of the
total weight of the food bars, and preferably ranges from about 20
to about 60 weight percent, with about 40 weight percent being most
preferred (for pregnant women, lactating women and women having
childbearing potential that are attempting to become pregnant).
[0091] The fat content of the food bars of the invention generally
ranges from about 0 to about 60 weight percent of the total weight
of the food bars, and preferably ranges from about 1 to about 40
weight percent, with about 20 weight percent being most preferred
(for pregnant women, lactating women and women having childbearing
potential that are attempting to become pregnant).
[0092] The moisture content of the food bars generally ranges from
about 0 to about 3 weight percent of the total weight of the food
bars, and preferably ranges from about 0 to about 1.5 weight
percent, with about 0 weight percent being most preferred. Because
water can cause the food bars of the invention to decompose, it is
preferred that the food bars contain no moisture.
[0093] The amount of calories that a particular food bar of the
invention will contain will vary widely depending upon a number of
factors, such as the ingredients employed to produce the bars, the
quantities of those ingredients used, and the weight and size of
the bars. However, it is preferred that the food bars of the
invention range from about 1 to about 1500 calories, with from
about 10 to about 600 calories being preferred, and about 200
calories being most preferred.
[0094] Methods for Supplementing Dietary Requirements
[0095] In a further aspect, the present invention provides a method
for supplementing the dietary requirements of pregnant women,
lactating women and women having childbearing potential that are
attempting to become pregnant and, consequently, the nutrition of
their developing fetuses and babies. This method comprises
administering one or more of the food bars of the present invention
to a pregnant woman per day throughout pregnancy, to a lactating
woman per day throughout the period of lactation, or to a woman
having childbearing potential that is attempting to become pregnant
per day until she becomes pregnant (and then throughout pregnancy
and lactation). If a food bar is prepared that contains all of the
vitamins, minerals and other nutritional supplements recommended
for consumption by pregnant women, lactating women or women of
childbearing potential that are attempting to become pregnant in
the largest daily quantity that is safe for these women, and for
their developing fetuses or babies, then these women would consume
one entire food bar per day (either all at one time, or divided
into two, three, four, five, six or more parts). If a food bar is
prepared that contains all of the vitamins, minerals and other
nutritional supplements recommended for consumption by pregnant
women, lactating women or women of childbearing potential that are
attempting to become pregnant, but only one half of the largest
daily quantity that is safe for these women, and for their
developing fetuses or babies, then these women would consume two
entire food bars per day (either together at once, or at different
times during the day). If a food bar is prepared that contains all
of the vitamins, minerals and other nutritional supplements
recommended for consumption by pregnant women, lactating women or
women of childbearing potential that are attempting to become
pregnant, but only one third of the largest daily quantity that is
safe for these women, and for their developing fetuses or babies,
then these women would consume three entire food bars per day
(either together at once, or at different times during the day). A
person of ordinary skill in the art can readily determine the
appropriate daily dosage of food bars of the invention in relation
to the type and quantity of vitamins, minerals and other
nutritional supplements that may be present in the food bars. For
pregnant women that experience morning sickness, it would be
preferable to eat several bite-sized food bars throughout the day
than to eat one larger food bar all at one time during the day.
[0096] The following example describes and illustrates the methods
for the preparation of the food bars of the present invention. This
example is intended to be merely illustrative of the present
invention, and not limiting thereof in either scope of spirit.
Those of skill in the art will readily understand that variations
of certain of the conditions and/or steps employed in the
procedures described in the example can be used to prepare and test
these food bars.
[0097] All of the materials and equipment employed in the example,
and generally employed to make and use the food bars of the present
invention, are commercially available from sources known by those
of skill in the art.
EXAMPLE
Preparation of Pre-Natal Chocolate-Coated, Orange-Flavored Caramel
and Rice Crisp Food Bars
[0098] 16,666 pre-natal chocolate-coated, orange-flavored caramel
and rice crisp food bars were prepared from a 1,000 kg batch of
material, using a partial cold-formed method. Each of the food bars
weighed 60 g, and contained the vitamins, minerals, and other
nutrients, and the quantities thereof, set forth below, including
the anti-constipation and regularity-maintaining agent calcium
polycarbophyll.
5 Quantity Vitamin Vitamin A 5000 I.U. Vitamin B.sub.1 (Thiamin) 3
mg Vitamin B.sub.2 (Riboflavin) 3.4 mg Vitamin B.sub.3 (Niacin) 20
mg Vitamin B.sub.6 (Pyridoxine) 10 mg Vitamin B.sub.9 (Folic Acid)
1 mg Vitamin B.sub.12 (cyanocobalamine) 12 mcg Biotin 30 mcg
Vitamin C 120 mg Vitamin D 400 I.U. Vitamin B 30 I.U. Mineral
Calcium 1300 mg Iron 27 mg Pantothenic Acid 10 mg Iodine 150 mcg
Magnesium 400 mg Zinc 25 mg Selenium 70 mcg Copper 2 mg Manganese 5
mg Chromium 25 mcg Molybdenum 25 mcg Other DHA 300 mg
Polycarbophyll 1000 mg (as Calcium Polycarbophyll)
Part I--Production of Binder for the Base of the Food Bars
[0099] Liquid sucrose (67.5% solids) (181.5631 kg) and maltodextrin
17DE (dextro equivalent) (78% solids) (64.1 kg) were added to a
first jacketed kettle (Kettle A), which had a conventional,
fixed-speed, high shear mixer and sweep agitator with side wall
scrappers placed therein. The liquid sucrose and maltodextrin were
then heated to 240.degree. F. while stirred together with the sweep
agitator, and this temperature was maintained until the solids
content of the mixture reached about 88%. The temperature was then
reduced to 172.degree. F. by adjusting the temperature control
present on the kettle (to have cool water run through the jacket of
the kettle).
[0100] Separately, sunflower oil (33.332 kg) was placed into a
small container and heated to 172.degree. F. The following
ingredients were then added to the heated sunflower oil while
mixing slowly: lecithin (0.99996 kg), ascorbyl palmitate (3.3332
kg), propyl gallate (0.0067 kg), palm oil (3.3332 kg), myverol oil
(0.0333 kg) and a pre-mix of oil-soluble vitamins (1.0 kg)
containing (per 60 mg) a quantity of Vitamin A (Vitamin A
Palmitate), Vitamin A (Beta Carotene), Vitamin D (Cholecalciferol)
and Vitamin E (d,l Alpha Tocopheryl Acetate) to provide the minimum
activity of these vitamins for the quantities of these vitamins
described hereinabove, and sunflower oil, to have the combined
ingredients total 1.0 kg. The ingredients were mixed until a
uniform blend was obtained.
[0101] The material present in Kettle A was then mixed with the
high shear mixer at the fixed speed in the down mode to form a
vortex. The following ingredients were then added into the vortex
present in Kettle A: cocoa powder (1.0 kg), reduced minerals whey
powder (49.998 kg), Flavor Savor No. 597.492A (0.3333 kg), orange
beck flavor 10342 (0.6666 kg) (Danisco A/S, Copenhagen, Denmark),
EDTA (33.332 kg), citric acid (0.0667 kg) and the sunflower oil
uniform blend described above. The high shear mixer was then
adjusted to the up mode, and mixing was continued until a uniform
blend was formed. The mixture was then cooled to 142.degree. F.,
and this temperature was maintained.
Part II--Production of Crisp Rice Mixture
[0102] Crisp rice (279.1555 kg) was added to a fixed-speed jacketed
ribbon blender. The blender was then started, and calcium
polycarbophyll (20.8325 kg) and DHA Powder (15% DHA) (33.332 kg)
were slowly added to the crisp rice while the blender was mixing.
These ingredients were mixed for about 10 minutes, until a uniform
blend was obtained. The mixture from Part I was then added to the
ribbon blender slowly, while mixing was occurring. The mixing
continued until another uniform blend was produced. The resulting
mixture was cooled to 142.degree. F. by adjusting the temperature
control present on the mixer (to have cool water run through the
jacket of the mixer). This temperature was then maintained.
Part III--Production of Caramel Blend
[0103] The following ingredients were added to another jacketed
kettle (Kettle B), which also had a conventional, fixed-speed, high
shear mixer and sweep agitator with side wall scrappers placed
therein: corn syrup 43 DE (80.7% solids) (23.6257 kg), liquid
sucrose (67.5% solids) (27.1594 kg), fructose powder (8.333 kg),
sodium chloride (0.6 kg), liquid skim milk (16.666 kg) and
palmolein oil (refined, blended and deodorized) (16.666 kg). The
ingredients were heated to 240.degree. F while they were stirred
together with the sweep agitator by adjusting the temperature
control present on the kettle (to have steam run through the jacket
of the kettle). The mixture was stirred and heated at 240.degree.
F. until the solids content of the mixture reached about 90.5%. The
temperature of the mixture was then reduced to 140.degree. F. by
adjusting the temperature control present on the kettle (to have
cool water run through the jacket of the kettle). Vanilla flavor
extract (0.3333 kg) was then added to the kettle, and the
ingredients were mixed for about 10 minutes.
[0104] A pre-mix (99.996 kg) containing (per 6,000 mg) a quantity
of the following water-soluble vitamins and minerals to provide the
minimum activity of these vitamins and minerals for the quantities
of these vitamins and minerals described hereinabove were slowly
added to Kettle B: Thiamin (Thiamin Mononitrate), Riboflavin,
Niacin (Niacinamide), Pyridoxine (Pyridoxine Hydrochloride), Folic
Acid, Vitamin B.sub.12 (Cyanocobalamine), Biotin, Vitamin C
(Ascorbic Acid), Calcium (Calcium Carbonate), Iron (Ferrous
Fumarate), Pantothenic Acid (d-Calcium Pantothenate), Iodine
(Potassium Iodide), Magnesium (Magnesium Oxide), Zinc (Zinc Oxide),
Selenium (Sodium Selenate), Copper (Cupric Oxide), Manganese,
(Manganese Sulfate), Chromium (Chromium Chloride), Molybdenum
(Sodium Molybdate) and Maltodextrin, QS to make 6,000 mg. The
ingredients in Kettle B were mixed for about 20 minutes, until a
uniform blend was obtained. The resulting uniform blend was
maintained at a temperature of 140.degree. F.
Part IV--Extrusion of Crisp Rice Mixture
[0105] The crisp rice mixture resulting from Part II was
transferred from the ribbon blender to an extruder, and the mass
was extruded, and then cut into approximately 40 g bars. The bars
were then passed through a cooling tunnel, and cooled to below
about 140.degree. F.
Part V--Top Coating of Caramel Blend
[0106] The caramel blend resulting from Part III was placed into
the hopper of a top coating machine. The crisp rice bars resulting
from Part IV were then passed through the top coating machine, and
approximately 12g of caramel blend was dispensed onto the top of
each bar by the top coating machine. The resulting bars were then
passed through a cooling tunnel, and cooled to about 85.degree.
F.
Part VI--Artificial Chocolate Confectioners Coating
[0107] Artificial chocolate confectioners coating (Kraft Foods,
Inc., Northfield, Ill.) (133.328 kg) was placed into the system
hopper of a cascading coating machine and allowed to recirculate
for about 20 minutes. The bars resulting from Part V were then
passed through the machine, and approximately 8 g of artificial
chocolate confectioners coating was added to the top, bottom and
sides of each bar. The resulting food bars were then passed through
a cooling tunnel, and cooled to about 60.degree. F.
Part VII--Packaging
[0108] The food bars resulting from Part VI were placed in a
packaging line, where they were each individually wrapped in a film
having oxygen barrier properties. Prior to sealing the wrapper of
each bar, the inner space of the wrapper for each bar was purged
with nitrogen. Then, sets of fourteen bars were placed into
separate aluminum cans. The cans were then passed into a vacuum
packer that replaced air with nitrogen. Each can was then
hermetically sealed and labeled, and kept at room temperature. The
bars produced in this Example did not need to be refrigerated (to
maintain freshness or to prevent the outside coating from
melting).
[0109] The resulting food bars each contained a caramel center, in
which the vitamins and minerals were present, and were slowly
released therefrom, and had an artificial chocolate confectioners
coating present thereon. The food bars each weighed about 60 g, and
had about 205 calories. They each had a carbohydrate content of 30
g, a protein content of 10 g, a fat content of 5 g, and a
cholesterol content of 22 mg. They were each rectangular with a
flat bottom and a slightly domed top, and 4 and 3/4 inches long, 1
and 1/2 inches wide, and 5/8 of an inch thick. None of the food
bars contained any marshmallow, taurine or flour. Each of the food
bars contained the following components:
6 Component Mg/Food Bar Liquid Sucrose (67.5% Solids) 8,453.600 mg
Maltodextrin 17 DE (78% Solids) 3,000.000 mg Sunflower Oil
2,000.000 mg Lecithin 60.000 mg Ascorbyl Palmitate 200.000 mg
Propyl Gallate 0.400 mg Palm Oil 200.000 mg Myverol Oil 2.000 mg
1st Vitamin/Mineral Pre-Mix (Part I) 60.000 mg Cocoa Powder 60.000
mg Reduced Minerals Whey Powder 3,000.000 mg Flavor Savor 597.492/A
20.000 mg Orange Beck Flavor 10342 40.000 mg EDTA 2,000.000 mg
Citric Acid 4.000 mg Water 3,200.000 mg Crisped Rice 16,750.000 mg
Calcium Polycarbophyll 1,250.000 mg DHA Powder (15% DHA) 2,000.000
mg Corn Syrup 1,144.000 mg Fructose Powder 500.000 mg Sodium
Chloride 36.000 mg Liquid Skim Milk 1,000.000 mg Palmolein Oil
1,000.000 mg Vanilla Flavor Extract 20.000 mg 2nd Vitamin/Mineral
Pre-Mix (Part III) 6,000.000 mg Artificial Chocolate Confectioner's
Coating 8,000.000 mg Total 60,000.000 mg (60 g)
[0110] One of these food bars may be administered per day to a
pregnant woman. The food bar may be consumed all at one time, or
may be divided into varying portions, with all of the portions
eaten within the same day. Food bars for lactating women, or for
women having childbearing potential that are attempting to become
pregnant, can also be produced according to the methods described
in this Example.
[0111] While the present invention has been described herein with
some specificity, and with reference to certain preferred
embodiments thereof, those of ordinary skill in the art will
recognize numerous variations, modifications and substitutions of
that which has been described which can be made, and which are
within the scope and spirit of the invention. It is intended that
all of these modifications and variations be within the scope of
the present invention as described and claimed herein, and that the
invention be limited only by the scope of the claims which follow,
and that such claims be interpreted as broadly as is
reasonable.
[0112] Throughout this application, various books, patents and
other publications have been cited. The entireties of each of these
books, patents and publications are hereby incorporated by
reference herein.
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