U.S. patent application number 09/885345 was filed with the patent office on 2001-12-27 for dietary supplements.
Invention is credited to Jackson, Sherry D..
Application Number | 20010055623 09/885345 |
Document ID | / |
Family ID | 27104228 |
Filed Date | 2001-12-27 |
United States Patent
Application |
20010055623 |
Kind Code |
A1 |
Jackson, Sherry D. |
December 27, 2001 |
Dietary supplements
Abstract
The present invention relates to dietary supplements containing
low doses of phytoestrogens for supplementing the specific
phytochemical dietary needs of perimenopausal and menopausal
women.
Inventors: |
Jackson, Sherry D.; (New
York, NY) |
Correspondence
Address: |
KENYON & KENYON
ONE BROADWAY
NEW YORK
NY
10004
US
|
Family ID: |
27104228 |
Appl. No.: |
09/885345 |
Filed: |
June 19, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09885345 |
Jun 19, 2001 |
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08873792 |
Jun 12, 1997 |
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6040333 |
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08873792 |
Jun 12, 1997 |
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08688448 |
Jul 30, 1996 |
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5654011 |
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Current U.S.
Class: |
424/630 ;
424/639; 424/643; 424/655; 424/657; 514/168 |
Current CPC
Class: |
A61K 33/32 20130101;
A61K 33/34 20130101; A61K 33/24 20130101; Y10S 514/899 20130101;
A23L 33/16 20160801; A23V 2002/00 20130101; Y10S 514/874 20130101;
A23L 33/15 20160801; A61K 33/32 20130101; A61K 2300/00 20130101;
A61K 33/34 20130101; A61K 2300/00 20130101; A23V 2002/00 20130101;
A23V 2250/156 20130101; A23V 2250/1586 20130101; A23V 2250/71
20130101; A23V 2250/704 20130101; A23V 2250/712 20130101; A23V
2250/708 20130101; A23V 2250/2116 20130101; A23V 2002/00 20130101;
A23V 2250/1578 20130101; A23V 2250/161 20130101; A23V 2250/1572
20130101; A23V 2250/1588 20130101; A23V 2250/1612 20130101; A23V
2250/1642 20130101; A23V 2250/1592 20130101; A23V 2250/156
20130101; A61K 33/34 20130101; A61K 33/32 20130101; A61K 33/30
20130101; A61K 33/26 20130101; A61K 33/24 20130101; A61K 33/22
20130101; A61K 33/06 20130101; A61K 31/714 20130101; A61K 31/59
20130101; A61K 31/565 20130101; A61K 31/505 20130101; A61K 31/44
20130101; A61K 31/375 20130101; A61K 31/355 20130101; A61K 31/07
20130101 |
Class at
Publication: |
424/630 ;
424/639; 424/643; 424/655; 424/657; 514/168 |
International
Class: |
A61K 033/34; A61K
033/32; A61K 033/24; A61K 033/22 |
Claims
What is claimed is:
1. A dietary supplement for supplementing the nutritional needs of
pre-perimenopausal women comprising about 200 to about 500 mg
calcium, about 100 to about 200 mg magnesium, about 0.5 to about
1.5 mg boron, about 0.5 to about 1.5 mg copper, about 2 to about
2.6 mg manganese, about 10 to about 13 mg zinc, about 200 to about
300 IU vitamin D, about 12 to about 18 mg iron, about 400 to about
440 .mu.g folic acid, about 2 to about 10 .mu.g vitamin B.sub.12,
about 50 to about 100 mg vitamin B.sub.6, about 50 to about 100
.mu.g chromium, about 100 to about 200 IU vitamin E, about 100 to
about 1000 mg vitamin C and about 8 to less than 50 mg
phytoestrogen in admixture with a biologically acceptable
carrier.
2. The dietary supplement of claim 1 which further comprises from
about 400 to about 1200 .mu.g RE preformed vitamin A and mixed
carotenoids.
3. The dietary supplement of claim 1 wherein said supplement is
formulated in tablet, powder, liquid, capsule or gel form, or
dietary bar.
4. The dietary supplement of claim 3 wherein said supplement is
formulated f or once daily administration.
5. The dietary supplement of claim 1 comprising about 200 to about
300 mg calcium, about 100 to about 150 mg magnesium, about 0.7 to
about 1.3 mg boron, about 0.7 to about 1.3 mg copper, about 2 to
about 2.4 mg manganese, about 10 to about 12 mg zinc, about 200 to
about 250 IU vitamin D, about 16 to about 18 mg iron, about 400 to
about 420 .mu.g folic acid, about 2 to about 4 .mu.g vitamin
B.sub.12, about 50 to about 65 mg vitamin B.sub.6, about 50 to
about 75 .mu.g chromium, about 100 to about 150 IU vitamin E, about
100 to about 150 mg vitamin C and about 8 to about 12 mg
phytoestrogen in admixture with a biologically acceptable
carrier.
6. The dietary supplement of claim 1 comprising about 200 mg
calcium, about 100 mg magnesium, about 1 mg boron, about 1 mg
copper, about 2 mg manganese, about 10 mg zinc, about 200 IU
vitamin D, about 18 mg iron, about 400 .mu.g folic acid, about 2
.mu.g vitamin B.sub.12, about 50 mg vitamin B.sub.6, about 50 .mu.g
chromium, about 100 IU vitamin E, about 100 mg vitamin C and about
10 mg phytoestrogen in admixture with a biologically acceptable
carrier.
7. A dietary supplement for supplementing the nutritional needs of
perimenopausal and menopausal women comprising from about 200 to
about 1000 mg calcium; from about 100 to about 200 mg magnesium;
from about 1.5 to about 2.5 mg boron; from about 1.5 to about 2.5
mg copper; from about 2.4 to about 3.6 mg manganese; from about 12
to about 15 mg zinc; from about 300 to about 400 IU vitamin D; from
about 10 to about 15 mg iron; from about 400 to about 440 .mu.g
folic acid; from about 2 to about 15 .mu.g vitamin B.sub.12; from
about 50 to about 100 mg vitamin B.sub.6; from about 75 to about
200 .mu.g chromium; from about 200 to about 400 IU vitamin E; from
about 200 to about 1000 mg vitamin C; and from about 10 to less
than 50 mg phytoestrogen in admixture with a biologically
acceptable carrier.
8. The dietary supplement of claim 7 which further comprises from
about 800 to about 1600 .mu.g RE preformed vitamin A and mixed
carotenoids.
9. The dietary supplement of claim 7 wherein said supplement is
formulated in tablet, powder, liquid, capsule or gel form, or
dietary bar.
10. The dietary supplement of claim 7 wherein said supplement is
formulated for once daily administration.
11. The dietary supplement of claim 7 comprising from about 300 to
about 400 mg calcium; from about 100 to about 150 mg magnesium;
from about 1.7 to about 2.3 mg boron; from about 1.7 to about 2.3
mg copper; from about 2.6 to about 3.4 mg manganese; from about 12
to about 14 mg zinc; from about 300 to about 350 IU vitamin D; from
about 13 to about 15 mg iron; from about 400 to about 420 .mu.g
folic acid; from about 2 to about 6 .mu.g vitamin B.sub.12; from
about 50 to about 65 mg vitamin B.sub.6; from about 75 to about 100
.mu.g chromium; from about 200 to about 300 IU vitamin E; from
about 200 to about 300 mg vitamin C; and from about 12 to about 17
mg phytoestrogen in admixture with a biologically accept-able
carrier.
12. The dietary supplement of claim 7 wherein said supplement
comprises about 300 mg calcium, about 150 mg magnesium, about 2 mg
boron, about 2 mg copper, about 3 mg manganese, about 12 mg zinc,
about 300 IU vitamin D, about 15 mg iron, about 400 .mu.g folic
acid, about 2 .mu.g vitamin B.sub.12, about 50 mg vitamin B.sub.6,
about 75 .mu.g chromium, about 200 IU vitamin E, about 200 mg
vitamin C, and about 15 mg phytoestrogen.
13. A dietary supplement for supplementing the nutritional needs of
post-menopausal women comprising about 200 to about 1500 mg
calcium, about 150 to about 250 mg magnesium, about 2.5 to about
3.5 mg boron, about 2.5 to about 3.5 mg copper, about 4.4 to about
5.6 mg manganese, about 15 to about 18 mg zinc, about 300 to about
800 IU vitamin D, about 5 to about 10 mg iron, about 400 to about
440 .mu.g folic acid, about 2 to about 18 .mu.g vitamin B.sub.12,
about 1.6 to about 10 mg vitamin B.sub.6, about 100 to about 200
.mu.g chromium, about 350 to about 800 IU vitamin E, about 300 to
about 1000 mg vitamin C and about 10 to less than 50 mg
phytoestrogen in admixture with a biologically acceptable
carrier.
14. The dietary supplement of claim 13 which further comprises from
about 1200 to about 2000 .mu.g RE preformed vitamin A and mixed
carotenoids.
15. The dietary supplement of claim 13 wherein said supplement is
formulated in tablet, powder, liquid, capsule, patch or gel form,
or dietary bar.
16. The dietary supplement of claim 13 wherein said supplement is
formulated for once daily administration.
17. The dietary supplement of claim 13 wherein said supplement
comprises about 300 to about 500 mg calcium, about 150 to about 200
mg magnesium, about 2.7 to about 3.3 mg boron, about 2.7 to about
3.3 mg copper, about 4.6 to about 5.4 mg manganese, about 15 to
about 17 mg zinc, about 350 to about 400 IU vitamin D, about 8 to
about 10 mg iron, about 400 to about 420 .mu.g folic acid, about 2
to about 8 .mu.g vitamin B.sub.12, about 1.6 to about 3.2 mg
vitamin B.sub.6, about 100 to about 150 .mu.g chromium, about 350
to about 450 IU vitamin E, about 350 to about 450 mg vitamin C and
about 12 to about 17 mg phytoestrogen in admixture with a
biologically acceptable carrier.
18. The dietary supplement of claim 13 wherein said supplement
comprises about 400 mg calcium, about 200 mg magnesium, about 3 mg
boron, about 3 mg copper, about 5 mg manganese, about 15 mg zinc,
about 400 IU vitamin D, about 10 mg iron, about 400 .mu.g folic
acid, about 2 .mu.g vitamin B.sub.12, about 1.6 mg vitamin B.sub.6,
about 100 .mu.g chromium, about 400 IU vitamin E, about 400 mg
vitamin C, and about 15 mg phytoestrogen in admixture with a
biologically acceptable carrier.
19. A series of nutritional supplements formulated for the
lifestage associated nutritional needs of a woman comprising at
least two of (A) a composition for preperimenopausal women
comprising about 200 to about 500 mg calcium, about 100 to about
200 mg magnesium, about 0.5 to about 1.5 mg boron, about 0.5 to
about 1.5 mg copper, about 2 to about 2.6 mg manganese, about 10 to
about 13 mg zinc, about 200 to about 300 IU vitamin D, about 12 to
about 18 mg iron, about 400 to about 440 .mu.g folic acid, about 2
to about 10 .mu.g vitamin B.sub.12, about 50 to about 100 mg
vitamin B.sub.6, about 50 to about 100 .mu.g chromium, about 100 to
about 200 IU vitamin E, about 100 to about 1000 mg vitamin C and
about 8 to less than 50 mg phytoestrogen in admixture with a
biologically acceptable carrier; (B) a composition for
perimenopausal and menopausal women comprising from about 200 to
about 1000 mg calcium; from about 100 to about 200 mg magnesium;
from about 1.5 to about 2.5 mg boron; from about 1.5 to about 2.5
mg copper; from about 2.4 to about 3.6 mg manganese; from about 12
to about 15 mg zinc; from about 300 to about 400 IU vitamin D; from
about 10 to about 15 mg iron; from about 400 to about 440 .mu.g
folic acid; from about 2 to about 15 .mu.g vitamin B.sub.12; from
about 50 to about 100 mg vitamin B.sub.6; from about 75 to about
200 .mu.g chromium; from about 200 to about 400 IU vitamin E; from
about 200 to about 1000 mg vitamin C; and from about 10 to less
than 50 mg phytoestrogen in admixture with a biologically
acceptable carrier; and (C) a composition for post-menopausal women
comprising about 200 to about 1500 mg calcium, about 150 to about
250 mg magnesium, about 2.5 to about 3.5 mg boron, about 2.5 to
about 3.5 mg copper, about 4.4 to about 5.6 mg manganese, about 15
to about 18 mg zinc, about 300 to about 800 IU vitamin D, about 5
to about 10 mg iron, about 400 to about 440 .mu.g folic acid, about
2 to about 18 .mu.g vitamin B.sub.12, about 1.6 to about 10 mg
vitamin B.sub.6, about 100 to about 200 .mu.g chromium, about 350
to about 800 IU vitamin E, about 300 to about 1000 mg vitamin C and
about 10 to less than 50 mg phytoestrogen in admixture with a
biologically acceptable carrier; whereby the changing nutritional
needs of a woman during preperimenopause, perimenopause and
menopause, and post-menopause are supplemented.
20. A once daily dietary supplement for supplementing the
nutritional needs of peri-menopausal and/or menopausal women
comprising less than about 20 mg phytoestrogen and a biologically
acceptable carrier.
21. The dietary supplement of claim 20 wherein the phytoestrogen is
selected from the group consisting of genistin, glycitin, daidzin,
malonyl daidzin, malonyl genistin, malonyl glycitin, acetyl
glycitin, acetyl daidzin, acetyl genistin, genistein, glycitein,
daidzein and mixtures thereof.
22. The dietary supplement of claim 20 wherein the phytoestrogen
comprises about 4.726 mg daidzin, about 1.257 mg glycitin, about
5.312 mg genistin, about 0.586 mg malonyl daidzin, about 0.217 mg
malonyl glycitin, about 0.510 mg malonyl genistin, about 0.670 mg
acetyl daidzin, about 0.082 mg acetyl glycitin, about 0.595 mg
acetyl genistin, about 0.0726 mg daidzein, about 0.062 mg
glycitein, and about 0.060 mg genistein.
23. The dietary supplement of claim 20 wherein the phytoestrogen
comprises about 31 to 35 wt % daidzin, about 8 to 10 wt % glycitin,
about 36 to 40 wt % genistin, about 3 to 5 wt % malonyl daidzin,
about 0.5 to 2.5 wt % malonyl glycitin, about 2.6 to 4.6 wt %
malonyl genistin, about 3.7 to 5.7 wt % acetyl daidzin, about 0.1
to 1.1 wt % acetyl glycitin, about 3.2 to 5.2 wt % acetyl genistin,
about 0.1 to 1.0 wt % daidzein, about 0.1 to 1.0 wt % glycitein,
and about 0.1 to 0.9 wt % genistein.
24. The dietary supplement of claim 20 wherein the phytoestrogen is
obtained from whole soybean extract.
25. The dietary supplement of claim 20 wherein the supplement
comprises less than about 10 to about 15 mg phytoestrogen.
26. The dietary supplement of claim 20 wherein the supplement is
formulated as a tablet, capsule, patch, gel, cream, chewing gum,
powder, beverage, confectionary bar or cereal.
27. A method for supplementing the dietary needs of peri-menopausal
and/or menopausal women said method comprising administering to the
woman an amount of less than about 20 mg phytoestrogen per day.
28. The method of claim 26 wherein the amount of phytoestrogen
administered is less than about 15 mg per day.
29. The method of claim 26 wherein the phytoestrogen is selected
from the group consisting of genistin, glycitin, daidzin, malonyl
daidzin, malonyl genistin, malonyl glycitin, acetyl glycitin,
acetyl daidzin, acetyl genistin, genistein, glycitein, daidzein and
mixtures thereof.
30. The method of claim 26 wherein the phytoestrogen is obtained
from whole soybean extract.
31. The method of claim 26 wherein the phytoestrogen comprises
about 4.726 mg daidzin, about 1.257 mg glycitin, about 5.312 mg
genistin, about 0.586 mg malonyl daidzin, about 0.217 mg malonyl
glycitin, about 0.510 mg malonyl genistin, about 0.670 mg acetyl
daidzin, about 0.082 mg acetyl glycitin, about 0.595 mg acetyl
genistin, about 0.0726 mg daidzein, about 0.062 mg glycitein, and
about 0.060 mg genistein.
32. The dietary supplement of claim 20 wherein the phytoestrogen
comprises about about 31 to 35 wt % daidzin, about 8 to 10 wt %
glycitin, about 36 to 40 wt % genistin, about 3 to 5 wt % malonyl
daidzin, about 0.5 to 2.5 wt % malonyl glycitin, about 2.6 to 4.6
wt % malonyl genistin, about 3.7 to 5.7 wt % acetyl daidzin, about
0.1 to 1.1 wt % acetyl glycitin, about 3.2 to 5.2 wt % acetyl
genistin, about 0.1 to 1.0 wt % daidzein, about 0.1 to 1.0 wt %
glycitein, and about 0.1 to 0.9 wt % genistein.
Description
[0001] This application is a continuation-in-part application of
application Ser. No. 08/688,448 filed on Jul. 30, 1996.
FIELD OF THE INVENTION
[0002] The present invention relates to dietary supplements. More
particularly, it relates to dietary supplements formulated to
supplement a woman's specific micronutrient and phytochemical needs
during each of her adult life stages, thereby promoting her well
being and preventing or reducing the health risks to which she is
exposed.
BACKGROUND OF THE INVENTION
[0003] The nutritional and health needs of women differ in many
respects from those of men. Moreover, they vary with each
developmental or life stage. For women, in particular, each adult
life stage poses wide ranging nutritional requirements that
significantly affect the health risks to which they are
exposed.
[0004] In general, women pass through three principal adult
developmental or life stages--the childbearing or
pre-perimenopausal stage; the perimenopausal and menopausal stage;
and the post-menopausal stage. Numerous health conditions and risks
may develop during each of these life stages. They include coronary
heart disease (CHD), some cancers, cervical dysplasia, menopause,
osteoporosis, pre-menstrual syndrome (PMS), iron deficiency anemia,
and fetal neural tube defects. The incidence of these conditions
and risks varies with each life stage and has been shown to be
influenced by diet and dietary supplements.
[0005] CHD is a major cause of death in women. It claims the lives
of nearly 250,000 women per year, most of whom are post-menopausal.
Although generally not manifest until the post-menopausal stage,
CHD develops over decades. Well established risk factors for CHD
include elevated plasma cholesterol levels and abnormal glucose
metabolism. Also implicated in the development of CHD are elevated
homocysteine levels and the effects of free radicals.
Phytoestrogens, antioxidants, chromium and folic acid have been
shown to mitigate these risk factors.
[0006] In general, the risk of cancer increases with age. Breast
cancer, which afflicts one in every nine women, is chief among
women's concerns. Both antioxidants and phytoestrogens appear to
have a role in the prevention of some cancers, particularly breast
cancer. Furthermore, folic acid has been shown to reduce the risk
of cervical dysplasia, which is a precursor to cervical cancer.
[0007] Menopause can result in various unpleasant symptoms,
including hot flashes, night sweats, mood swings, insomnia and
fatigue. Phytoestrogens have been shown to reduce these
symptoms.
[0008] Osteoporosis is associated with the aging process and
predominantly affects women. It is characterized by diminished bone
density, which results in increased bone fractures and vertebral
column collapse. Bone loss begins around age 35. This loss
accelerates during the menopause, which generally occurs around age
45 to 55. Osteoporosis develops over decades and is related to peak
bone mass, as well as to the degree of bone loss. Adequate calcium
intake prevents osteoporosis. Moreover, certain vitamins and
minerals enhance calcium absorption and utilization.
[0009] PMS is a common recurring multi-symptom condition
experienced by many menstruating women. Symptoms include water
retention, breast tenderness, headaches, mood swings, etc. Vitamin
B.sub.6 has been shown to reduce some of these symptoms.
[0010] Iron deficiency anemia is also prevalent in women,
particularly in menstruating women, but can also be found among
elderly women. Treatment of iron-deficiency anemia generally
consists of iron supplementation. Iron, however, is not readily
absorbed and can cause constipation, particularly in the elderly.
The presence of vitamin C in adequate amounts increases the
bioavailability of iron.
[0011] Fetal neural tube defects may occur during the first month
of gestation, often before a woman is aware of her pregnancy. Folic
acid prevents fetal neural tube defects and, therefore, should be
consumed in sufficient quantities by women of child-bearing
age.
[0012] Preventive measures are probably the most effective method
of dealing with these conditions and such measures should include
diet and dietary supplementation. Although the etiology of disease
is multi-factorial, certain dietary supplements have been shown to
provide a statistically significant benefit in reducing the risk or
reducing the incidence of various diseases and conditions. However,
to date, the approach to micronutrient supplementation has not
considered the changing needs of adult women. A more
individualized, sophisticated, and targeted approach is clearly
necessary. Because the incidence of these conditions varies with
the different life stages of a woman, there is a need for dietary
supplementation targeted to these changing health risks at each of
the life stages.
SUMMARY OF THE INVENTION
[0013] In one aspect of the present invention there are provided
dietary supplements for supplementing the dietary needs of women
and preventing or reducing life stage associated health risks
during each of their principal adult life stages
(pre-perimenopause, perimenopause and menopause, or
post-menopause).
[0014] In one embodiment of this aspect of the invention there is
provided a dietary supplement for supplementing the micronutrient
and phytochemical needs of pre-perimenopausal women to prevent or
reduce the risk of fetal neural tube defects, iron deficiency
anemia, PMS, osteoporosis, coronary heart disease, cervical
dysplasia and some cancers throughout that stage and the rest of a
woman's life, comprising about 200 to about 500 mg calcium, about
100 to about 200 mg magnesium, about 0.5 to about 1.5 mg boron,
about 0.5 to about 1.5 mg copper, about 2 to about 2.6 mg
manganese, about 10 to about 13 mg zinc, about 200 to about 300 IU
vitamin D, about 12 to about 18 mg iron, about 400 to about 440
.mu.g folic acid, about 2 to about 10 .mu.g vitamin B.sub.12, about
50 to about 100 mg vitamin B.sub.6, about 50 to about 100 .mu.g
chromium, about 100 to about 200 IU vitamin E, about 100 to about
1000 mg vitamin C and about 8 to less than 50 mg phytoestrogen in
admixture with a biologically acceptable carrier.
[0015] In another embodiment of this aspect of the invention the
dietary supplement is formulated to supplement the changing
nutritional needs of perimenopausal and menopausal women for the
prevention or reduction of the risk of PMS, symptoms of menopause,
fetal neural tube defects, osteoporosis, CHD, cervical dysplasia
and some forms of cancer throughout that stage and the rest of a
woman's life. This dietary supplement comprises from about 200 to
about 1000 mg calcium; from about 100 to about 200 mg magnesium;
from about 1.5 to about 2.5 mg boron; from about 1.5 to about 2.5
mg copper; from about 2.4 to about 3.6 mg manganese; from about 12
to about 15 mg zinc; from about 300 to about 400 IU vitamin D; from
about 10 to about 15 mg iron; from about 400 to about 440 .mu.g
folic acid; from about 2 to about 15 .mu.g vitamin B.sub.12; from
about 50 to about 100 mg vitamin B.sub.6; from about 75 to about
200 .mu.g chromium; from about 200 to about 400 IU vitamin E; from
about 200 to about 1000 mg vitamin C; and from about 10 to less
than 50 mg phytoestrogen in admixture with a biologically
acceptable carrier.
[0016] In yet another embodiment of this aspect of the invention
the dietary supplement is formulated to supplement the increased
nutritional needs of post-menopausal women for the prevention or
reduction of the risk of coronary heart disease, some forms of
cancer and osteoporosis throughout the final stage of her life.
This dietary supplement comprises about 200 to about 1500 mg
calcium, about 150 to about 250 mg magnesium, about 2.5 to about
3.5 mg boron, about 2.5 to about 3.5 mg copper, about 4.4 to about
5.6 mg manganese, about 15 to about 18 mg zinc, about 300 to about
800 IU vitamin D, about 5 to about 10 mg iron, about 400 to about
440 .mu.g folic acid, about 2 to about 18 .mu.g vitamin B.sub.12,
about 1.6 to about 10 mg vitamin B.sub.6, about 100 to about 200
.mu.g chromium, about 350 to about 800 IU vitamin E, about 300 to
about 1000 mg vitamin C and about 10 to less than 50 mg
phytoestrogen in admixture with a biologically acceptable
carrier.
[0017] The dietary supplements of this invention may be formulated
as a tablet, capsule, powder, gel or liquid, or dietary bar and are
preferably formulated for once daily administration. They may be
provided as a series or as individual compositions.
[0018] In another aspect of the invention, there is provided a
method for supplementing the dietary needs and preventing or
reducing life stage associated health risks in pre-perimenopausal
women, perimenopausal and menopausal women, and/or post-menopausal
women. This method comprises the administration to the woman of an
effective amount of the life stage appropriate dietary supplement
of the invention throughout that life stage. Preferably, a life
stage appropriate dietary supplement of the invention is
administered throughout each of the three principal adult life
stages of the woman.
[0019] Unexpectedly, the compositions of the present invention
provide women with physiologically effective phytoestrogen even
when phytoestrogens are administered at levels of less than 25 mg
per day, preferably at levels of less than 20 mg per day. As such,
it is another advantage of this invention to provide compositions
and methods for supplementing women's micronutrient needs by
providing phytoestrogens at these levels.
[0020] In another aspect of the invention there is provided a once
daily dietary supplement formulated specifically for the
nutritional needs of peri-menopausal and menopausal women. This
dietary supplement comprises less than about 20 mg phytoestrogen,
preferably less than about 15 mg, and most preferably about 14.5 mg
to about 1 mg phytoestrogen once a day in admixture with a
biologically acceptable carrier.
[0021] There is further provided a method of supplementing the
dietary needs of peri-menopausal and menopausal women. This method
comprises administering a composition comprising less than 20 mg
phytoestrogen, preferably less than about 15 mg and most preferably
from less than about 14.5 mg to about 1 mg phytoestrogen once per
day to a woman in need thereof in admixture with a biologically
acceptable carrier.
DETAILED DESCRIPTION OF THE INVENTION
[0022] The present invention provides dietary supplements for women
that are designed to meet a woman's health needs at each particular
stage of her life, such as pre-perimenopause, perimenopause and
menopause, or post-menopause, or during transition from one such
life cycle into the next. This is accomplished by supplying, in the
dietary supplements of the invention, a variety of nutrients that
address common health risks associated with each of these life
stages. Thus, each of the dietary supplements of the present
invention provides a variety of nutrients, including antioxidants
to increase the resistance of LDL cholesterol to oxidation,
elements to enhance calcium absorption and utilization, nutrients
to address iron deficiency anemia, folic acid to prevent fetal
neural tube defects, compounds to reduce serum homocysteine and
improve the lipid profile and phytoestrogens to reduce the symptoms
of menopause, as well as to help in the prevention of osteoporosis,
breast cancer and CHD. Furthermore, the amount of each nutrient
present varies according to the life stage for which the
composition is targeted.
[0023] The life stage specific dietary supplements of this
invention are not meant to replace a well-balanced diet, but are
instead intended to supplement a prudent diet. Unlike known
broad-based dietary supplements, this invention does not merely
provide the prescribed Recommended Daily Allowance (RDA) of
micronutrients, but rather is geared to emphasize the disease
prevention properties of micronutrient supplementation. Thus,
cumulative beneficial and preventive effects should be achieved by
dietary supplementation with the appropriate dietary supplement of
the invention, especially when diligently used for more than one
life stage.
[0024] As discussed above, a woman passes through three principal
adult life stages. The onset of each of the various lifestages can
occur at different ages for different individuals and the ages
suggested below for the various lifestages are only approximations.
The pre-perimenopause life stage (Stage I), approximately ages 18
to 45, includes the child-bearing or reproductive life stage, which
is a period of maximum ovarian function. Major health concerns that
arise during this life stage include iron deficiency anemia, PMS
and prevention of neural tube defects during pregnancy.
[0025] The perimenopause and menopause stage (Stage II),
approximately ages 45 to 55, is characterized by decreasing ovarian
function. At first, menstrual cycles may be erratic and PMS may
intensify. For 80% of all women this stage will eventually include
symptoms of the menopause, such as hot flashes, night sweats,
insomnia, fatigue, and mood swings. The rate of bone loss
accelerates and the lipid profile becomes more atherogenic, thus
setting the stage for the future onset of CHD and osteoporosis.
[0026] The final stage, post-menopause (Stage III), age 55 plus, is
characterized by complete cessation of ovarian function and an
increase in the incidence of cancer, osteoporotic fracture and CHD.
Menstrual related anemia, PMS and pregnancy are no longer health
concerns during this life stage.
[0027] The dietary supplements of this invention contain vitamins,
minerals and other compounds that are specifically included to
address common health concerns that arise during each of these life
stages. Moreover, s they are formulated to prevent or lessen the
risk of conditions known to develop in later life stages. For
example, the dietary supplement intended for use during
pre-perimenopause (Stage I dietary supplement) contains compounds
to counter the risk of fetal neural tube defects, lessen or prevent
PMS and iron deficiency anemia and prevent or lessen the risk of
osteoporosis, coronary heart disease and cancer, which are
generally manifest in the post-menopause life stage.
[0028] Phytoestrogens are included in each of the dietary
supplements of this invention. These compounds have been
demonstrated by clinical trials to modulate the menstrual cycle,
reduce menopausal symptoms, and lower LDL cholesterol levels. J.
Nutr., 1996, 126(1): 161-7; N. Engl. J. Med., 1995, 333: 276-82.
Epidemiologic observations indicate women in countries where diets
are rich in phytoestrogen (averaging about 40-50 mg/day) have a
decreased incidence of breast cancer, menopausal symptoms and
osteoporosis. Nutr. Cancer, 1994, 21:113-131; J. Nutr., 1995, 125;
757S-770S; Am. J. Clin. Nutr. 1995, 62:645. Animal studies have
provided a biological basis for these observations. J. Ster.
Biochem & Mol. Bio., 1992, 41(3-8): 331-7; First International
Symposium on the role of Soy and Preventing and Treating Chronic
Disease (1994), Speaker Abstracts.
[0029] In particular, with respect to alleviating menopausal
symptoms, the use of moderate to high levels, i.e., generally from
at least 20 to 90 mg per day of phytoestrogens, to reduce the
symptoms of menopause is known in the art. Some researchers believe
that a diet having such moderate to high levels of phytoestrogens
may play a role in reducing the incidence of distressful symptoms
of menopause; others believe that phytoestrogens alone are
inadequate without adjunctive therapy. Adlercruetz, et al. INPHARMA
(1996), Examining the Benefits of Dietary Phytoestrogens;
Adlercruetz, et al., The Lancet (1992), 339:1233. Id. U.S. Pat. No.
5,498,631 discloses that moderate to high levels of isoflavonoids
effectively reduce the symptoms of is conditions caused by altered
levels of estrogen such as menopause and premenstrual syndrome.
Solgar, a New Jersey company, provides a pill called "Genistein"
formulated from soy isoflavone extract containing 15 to 20 mg of a
mixture of genestein and daidzein for twice daily consumption,
which would provide at least 30 to 40 mg phytoestrogen per day.
[0030] Phytoestrogens are a class of isoflavones or isoflavonoids
derived from plants, commonly soy beans. The plant source, however,
is not critical. Some phytoestrogens, such as genistin, glycitin
and diadzin contain a glycosidic moiety, whereas other
phytoestrogens are nonglycosylated, e.g., genistein, glycitein and
daidzein. Phytoestrogens obtained from a single plant generally are
a mixture of both glycosylated and nonglycosylated forms. The
present dietary supplements generally contain a mixture of
phytoestrogens; however, purfied phytoestrogens may he used.
Mixtures of phytoestrogen may be obtained commercially.
Phytoestrogen levels of less than 25 mg per day, preferably greater
than 5 to about 25 mg per day, and most preferably about 10 to
about 20 mg per day, provide women with phytoestrogen levels that
are physiologically effective and may be used to supplement women's
micronutrient needs.
[0031] Vitamin B.sub.12, vitamin B.sub.6 and folic acid are
included in each of the life stage specific dietary supplements of
this invention. These elements act synergistically to reduce serum
homocysteine, high levels of which are associated with coronary
heart disease. Am. J. Clin. Nutr., 1992, 55:131-138; New Eng. J.
Med., 1992, 32:1832-1835; Am J. Clin. Nutr., 1989, 50:353-358. The
amount of folic acid in the three dietary supplements of this
invention is maintained at about the same level in all three
compositions, since folic acid not only reduces the risk of fetal
neural tube defects, but, as noted above, also has been shown to
have beneficial cardiac effects and to decrease the risk of
cervical dysplasia. Scand. J. Clin. Lab Invest., 1988, 48:215-221.
On the other hand, larger doses of vitamin B.sub.6 are included in
the Stage I and Stage II formulations, as compared to Stage III, to
assist in alleviating PMS symptoms. J. Royal Coll. Gen. Prac.,
1989, 39:364-368; Obstetrics and Gyn., 1987, 70:147-149.
[0032] Other components of the dietary supplements of this
invention include vitamin D, calcium, magnesium, manganese, copper,
zinc, boron and chromium. The combination of vitamin D, and
magnesium, manganese, copper, zinc, and boron (the "enhancement
compounds") acts synergistically with calcium to improve calcium
absorption and/or utilization and thereby enhance bone density. Am.
J. Clin. Nutr., 1982, 36:1046-1059; J. Am Col. Nutr., 1993,
12:383-389; Magnesium Trace Elem., 1990, 9:61-69; Am. J. Clin.
Nutr., 1991, 54:177S-226S; Clin. Obstetrics and Gyn., 1987,
30:789-811. Chromium is included to optimize glucose and lipid
metabolism. Diabetes Care, 1994, 17:1449-1452; Metabolism, 1992,
41:768-771; Biol. Trace Element Res., 1992, 32:19-24.
[0033] Aging is associated with an increased production of oxygen
free radicals (highly toxic molecules) which contribute to the
pathogenesis of many chronic diseases. This invention is formulated
to address this issue. Thus, antioxidants, such as vitamin E, are
included particularly to reduce atherogenicity of LDL cholesterol
particles which reduces damage to arterial walls. Am. J. Clin.
Nutr., 1991, 53:305S-313S; Lancet, 1996, 347:781-786. Another
antioxidant, Vitamin C, is included to lower the risk of breast and
other cancers. Vitamin E and Vitamin C may work together in a
synergistic fashion. Am. J. Clin. Nutr. 1991, 54: 1310S-1314S.
[0034] Each of the life stage dietary supplements of this invention
are formulated specifically to contain an amount of each of the
above-discussed components sufficient to prevent or reduce health
risks associated with Stage I, Stage II or Stage III of a woman's
life.
[0035] The dose of iron is highest in the Stage I dietary
supplement of this invention and lowest in the Stage III dietary
supplement, because iron deficiency anemia is a major health
concern of menstruating women (Stage I and part of Stage II).
Vitamin B.sub.12 deficiency results in pernicious anemia. Because
this condition can be clinically masked if folate is provided in
the diet without vitamin B.sub.12, all formulations of this
invention contain both folic acid and Vitamin B.sub.12.
[0036] Stage I compositions also contain an amount of vitamin
B.sub.6 sufficient to reduce symptoms of PMS and to compensate for
reduced levels of this vitamin caused by oral contraceptive use.
The amount of folic acid contained in the Stage I nutritional
supplement is sufficient to prevent fetal neural tube defects
during pregnancy, as well as to reduce the risk of cardiovascular
disease by maintaining low homocysteine levels. It also reduces the
risk of cervical dysplasia.
[0037] Thus, the Stage I dietary supplement contains an amount of
vitamin B.sub.6 sufficient to reduce the effects of PMS, an amount
of folic acid sufficient to prevent fetal neural tube defects and
provide cardiac benefit, a sufficient amount of vitamin B.sub.12 to
act in concert with vitamin B.sub.6 and folic acid present in the
composition to reduce the levels of serum homocysteine, a
sufficient amount of chromium to enhance glucose and lipid
metabolism, antioxidants to help prevent CHD and some cancers, and
calcium, together with a combination of other nutrients known to
enhance its absorption and/or utilization to prevent osteoporosis,
and an amount of phytoestrogens to beneficially modulate menses and
provide protection against osteoporosis, some cancers and CHD. The
Stage I dietary supplement is therefore particularly suited to meet
the needs and address the health risks of a young adult female,
while also lessening the risk of osteoporosis, cancer and coronary
heart disease occurring in later life.
[0038] The dietary supplements formulated for the perimenopause and
menopause lifestage (Stage II composition) include a higher dosage
of phytoestrogens than used in the dietary supplement for the
pre-perimenopausal lifestage because phytoestrogens reduce
menopausal symptoms, and to provide even more protection against
osteoporosis, cancer and CHD, the incidence of all of which
increases with age. Similarly, components that affect calcium
uptake and utilization are also increased in the Stage II dietary
supplement since the amount of bone loss increases with
menopause.
[0039] Concomitant with the onset of the menopause is a worsening
of the lipid profile. LDL-cholesterol and total cholesterol
increase significantly, while HDL-cholesterol decreases. To address
this problem, the levels of both phytoestrogens and chromium have
been increased in the Stage II composition relative to the Stage I
composition. antioxidant levels have also been increased to help
prevent the age-related onset of CHD s and breast cancer.
[0040] The Stage III dietary supplement of this invention is
formulated to address the health concerns and health risks that
occur with greater frequency in the post-menopausal years, e.g.,
osteoporosis, cancer and coronary heart disease. Stage III
compositions contain phytoestrogen in the same concentration as
Stage II. However, calcium, vitamin D, and the enhancement
compounds are increased, as are the antioxidants and chromium.
Chromium has a positive effect on blood sugar levels and the lipid
profile. On the other hand, the levels of vitamin B.sub.6 and iron
are decreased, because the health concerns addressed by higher
amounts of these components are of less relevance.
[0041] Optionally, the dietary supplements of this invention may
further contain an amount of vitamin A or mixed carotenoids
sufficient to supplement the nutritional needs of a woman at a
particular lifestage. Vitamin A may be provided as preformed
vitamin A or as mixed carotenoids, or both. There are more than 500
naturally occurring carotenoids, about 50 of which can serve as
precursors of retinol and therefore have provitamin A activity.
These include alpha- and beta-carotene and cryptoxanthin. However,
non provitamin A carotenoids, such as lutein and lycopene have also
been shown to have beneficial effects and may also be provided.
Lycopene intake, for example, has been inversely associated with
the risk of cervical cancer. Nutr & Cancer 1994, 21:193-201;
Internat J. Cancer 1991; 48:34-8.
[0042] The amount of preformed vitamin A and mixed carotenoids
included in the Stage I dietary supplement is in the range of about
400 to about 1200 .mu.g RE, preferably about 600 to about 1000
.mu.g RE, and most preferably about 800 .mu.g RE. The amount of
preformed vitamin A and mixed carotenoids included in the Stage II
dietary supplement is in the range of about 800 to about 1600 .mu.g
RE, preferably about 1000 to about 1400 .mu.g RE, and most
preferably about 1200 .mu.g RE. The amount of preformed vitamin A
and mixed carotenoids included in the Stage III dietary supplement
is in the range of about 1200 to about 2000 .mu.g RE, preferably
about 1400 to about 1800 .mu.g RE, and most preferably about 1600
.mu.g RE. Preferably, the amount of preformed vitamin A is about
200 to about 400 .mu.g RE, and most preferably about 400 .mu.g
RE.
[0043] Each of the dietary supplements of this invention is
formulated to prevent and reduce the risk of disease during one of
three specific life stages, during the transition from one life
stage to the next, and during later stages of life. Administration
of the dietary supplements of this invention during the appropriate
life stage reduces the risk factors for disease, such as iron
deficiency anemia during the pre-perimenopausal life stage, high
cholesterol during the perimenopausal and menopausal life stage,
and CHD, osteoporosis, and some cancers during the post-menopausal
life stage.
[0044] Maximum benefit is obtained by supplementation of the diet
with the life stage appropriate dietary supplement throughout the
entire life cycle; however, benefit is also obtained when
supplementation is begun at any time during a particular life
cycle.
[0045] For example, supplementation of the diet with the Stage I
dietary supplement at age 30 to 40, which is well into the
pre-perimenopausal life stage, lowers the risk of, or prevents,
future osteoporosis, cancer and coronary heart disease, and
provides health benefits to those conditions that present during
this life cycle, e.g., PMS, fetal neural tube defects, and iron
deficiency anemia. It is understood that the phrase "administration
throughout the life cycle", as used herein, means continual
administration from any time during a life cycle that
supplementation is begun.
[0046] The dietary supplements of the present invention may be
formulated using any pharmaceutically acceptable forms of the
vitamins, minerals and other nutrients discussed above, including
their salts. Preferred forms are calcium carbonate, magnesium
hydroxide or magnesium sulfate, sodium tetraborate, cupric oxide,
manganese sulfate, zinc sulfate, cholecalciferol, ferrous fumarate,
pyridoxine hydrochloride, chromium picolinate, d-alpha-tocopherol
acetate, and ascorbic acid. They may be formulated into capsules,
tablets, powders, gels or liquids. The dietary supplements may be
formulated as powders, for example, for mixing with consumable
liquids such as milk, juice, water or consumable gels or syrups for
mixing into other dietary liquids or foods. The dietary supplements
of this invention may be formulated with other foods or liquids to
provide premeasured supplemental foods, such as single serving
bars, for example. Flavorings, binders, protein, complex
carbohydrates, and the like may be added as needed.
[0047] The dietary supplements of the invention are intended for
daily administration. Preferably, they are formulated for
once-daily administration, but may be formulated in multiple
portions or as time release compositions for more or less frequent
administration; for example, the dietary supplement may be
formulated as two tablets for twice daily administration, or as a
sustained release capsule for administration every three days. In
the latter instance, the capsule is formulated to release the daily
amount of nutrients prescribed by the dietary supplements of the
invention during each of the three days. For reasons of size (ease
of swallowing) or improved bioabsorption or utilization (e.g.,
before or after a meal or before sleep), a given dosage may be
divided into two, three, or more tablets (or capsules, etc.). A
daily dosage may be administered as one tablet, as two tablets
taken together, or as two tablets taken separately (e.g., one in
the morning and one in the evening).
[0048] Specific formulation for each of the three lifestage
specific dietary supplements is provided below.
Stage I Dietary Supplement
[0049] The dietary supplement for pre-perimenopausal women includes
from about 200 to about 500 mg calcium, preferably from about 200
to about 300 mg calcium, and most preferably about 200 mg calcium;
from about 100 to about 200 mg magnesium, preferably from about 100
to about 150 mg magnesium, and most preferably about 100 mg
magnesium; from about 0.5 to about 1.5 mg boron, preferably about
0.7 to about 1.3 mg boron, and most preferably about 1 mg boron;
from about 0.5 to about 1.5 mg copper, preferably about 0.7 to
about 1.3 mg copper, and most preferably about 1 mg copper; from
about 2 to about 2.6 mg manganese, preferably about 2 to about 2.4
mg manganese, and most preferably about 2 mg manganese; from about
10 to about 13 mg zinc, preferably about 10 to about 12 mg zinc,
and most preferably about 10 mg zinc; from about 200 to about 300
IU vitamin D, preferably about 200 to about 250 IU vitamin D, and
most preferably about 200 IU vitamin D; from about 12 to about 18
mg iron, preferably about 16 to about 18 mg iron, and most
preferably about 18 mg iron; from about 400 to about 440 .mu.g
folic acid, preferably about 400 to about 420 .mu.g folic acid, and
most preferably about 400 .mu.g folic acid; from about 2 to about
10 .mu.g vitamin B.sub.12, preferably about 2 to about 4 .mu.g
vitamin B.sub.12, and most preferably about 2 .mu.g vitamin
B.sub.12; from about 50 to about 100 mg vitamin B.sub.6, preferably
about 50 to about 65 mg vitamin B.sub.6, and most preferably about
50 mg vitamin B.sub.6; from about 50 to about 100 .mu.g chromium,
preferably about 50 to about 75 .mu.g chromium, and most preferably
about 50 .mu.g chromium; from about 100 to about 200 IU vitamin E,
preferably about 100 to about 150 IU vitamin E, and most preferably
about 100 IU vitamin E; from about 100 to about 1000 mg vitamin C,
preferably about 100 to about 150 mg vitamin C, and most preferably
about 100 mg vitamin C; and from about 8 to less than 50 mg
phytoestrogen, preferably about 8 to about 12 mg phytoestrogen, and
most preferably about 10 mg phytoestrogen.
[0050] This range of folic acid has been shown to be effective in
preventing fetal neural tube defects and reducing the risk of
cervical dysplasia; the amount of vitamin B.sub.6 is sufficient to
reduce at least some symptoms of PMS; the amounts of vitamin
B.sub.12, vitamin B.sub.6 and folic acid have been shown to reduce
serum homocysteine; the amount of iron present in the composition
is sufficient to reduce or prevent iron deficiency anemia; and
phytoestrogen, antioxidants and chromium help reduce the risk of
cardiovascular disease. Antioxidants and phytoestrogens also
provide some protection against osteoporosis and some cancers.
[0051] A preferred Stage I daily dietary supplement is shown in
Table I.
Stage II Dietary Supplement
[0052] The dietary supplement for perimenopausal and menopausal
women includes from about 200 to about 1000 mg calcium, preferably
from about 300 to about 400 mg calcium, and most preferably about
300 mg calcium; from about 100 to about 200 mg magnesium,
preferably from about 100 to about 150 mg magnesium, and most
preferably about 150 mg magnesium; from about 1.5 to about 2.5 mg
boron, preferably about 1.7 to about 2.3 mg boron, and most
preferably about 2 mg boron; from about 1.5 to about 2.5 mg copper,
preferably about 1.7 to about 2.3 mg copper, and most preferably
about 2 mg copper; from about 2.4 to about 3.6 mg manganese,
preferably about 2.6 to about 3.4 mg manganese, and most preferably
about 3 mg manganese; from about 12 to about 15 mg zinc, preferably
about 12 to about 14 mg zinc, and most preferably about 12 mg zinc;
from about 300 to about 400 IU vitamin D, preferably about 300 to
about 350 IU vitamin D, and most preferably about 300 IU vitamin D;
from about 10 to about 15 mg iron, preferably about 13 to 15 mg
iron, and most preferably about 15 mg iron; from about 400 to about
440 .mu.g folic acid, preferably about 400 to about 420 .mu.g folic
acid, and most preferably about 400 .mu.g folic acid; from about 2
to about 15 .mu.g vitamin B.sub.12, preferably about 2 to about 6
.mu.g vitamin B.sub.12, and most preferably about 2 .mu.g B.sub.12,
from about 50 to about 100 mg vitamin B.sub.6, preferably about 50
to about 65 mg vitamin B.sub.6, and most preferably about 50 mg
vitamin B.sub.6; from about 75 to about 200 .mu.g chromium,
preferably about 75 to about 100 .mu.g chromium, and most
preferably about 75 .mu.g chromium; from about 200 to about 400 IU
vitamin E, preferably about 200 to about 300 IU vitamin E, and most
preferably about 200 IU vitamin E; from about 200 to about 1000 mg
vitamin C, preferably about 200 to about 300 mg vitamin C, and most
preferably s about 200 mg Vitamin C; and from about 10 to less than
50 mg phytoestrogen, preferably about 12 to about 17 mg
phytoestrogen, and most preferably 15 mg phytoestrogen.
[0053] The amount of calcium, magnesium, boron, copper, manganese,
zinc and vitamin D in the Stage II composition has been increased
in comparison to the Stage I composition since these nutrients have
been shown to enhance calcium absorption and/or utilization; the
amount of vitamin B.sub.6 is the same as in the Stage I composition
and is sufficient to prevent or reduce symptoms of PMS; the amounts
of folic acid will prevent fetal neural tube defects and reduce the
risk of cervical dysplasia, and in combination with vitamin
B.sub.12 and vitamin B.sub.6 is associated with a reduced risk of
CHD; chromium has also been increased to help regulate the lipid
profile and thereby reduce the risk of CHD; the amount of
phytoestrogen contributes to the reduction of menopausal symptoms,
osteoporosis, CHD and some forms of cancer, and therefore is
increased in the composition for the second life stage. Similarly,
the amount of antioxidants are increased in the Stage II
composition because they also provide protection against CHD and
some cancers.
[0054] A preferred Stage II daily dietary supplement is shown in
Table I.
Stage III Dietary Supplement
[0055] The dietary supplement for post-menopausal women includes
from about 200 to about 1500 mg calcium, preferably from about 300
to about 500 mg calcium, and most preferably about 400 mg calcium;
from about 150 to about 250 mg magnesium, preferably from about 150
to about 200 mg magnesium, and most preferably about 200 mg
magnesium; from about 2.5 to about 3.5 mg boron, preferably about
2.7 to about 3.3 mg boron, and most preferably about 3 mg boron;
from about 2.5 to about 3.5 mg copper, preferably about 2.7 to
about 3.3 mg copper, and most preferably about 3 mg copper; from
about 4.4 to about 5.6 mg manganese, preferably about 4.6 to about
5.4 mg manganese, and most preferably about 5.0 mg manganese; from
about 15 to about 18 mg zinc, preferably about 15 to about 17 mg
zinc, and most preferably about 15 mg zinc; from about 300 to about
800 IU vitamin D, preferably about 350 to about 400 IU vitamin D,
and most preferably about 400 IU vitamin D; from about 5 to about
10 mg iron, preferably about 8 to 10 mg iron, and most preferably
about 10 mg iron; from about 400 to about 440 .mu.g folic acid,
preferably about 400 to about 420 .mu.g folic acid, and most
preferably about 400 .mu.g folic acid; from about 2 to about 18
.mu.g vitamin B.sub.12, preferably about 2 to about 8 .mu.g vitamin
B.sub.12, and most preferably about 2 .mu.g vitamin B.sub.12; from
about 1.6 to about 10 mg vitamin B.sub.6, preferably about 1.6 to
3.2 mg vitamin B.sub.6, most preferably about 1.6 mg vitamin
B.sub.6; from about 100 to about 200 .mu.g chromium, preferably
about 100 to about 150 .mu.g chromium, and most preferably about
100 .mu.g chromium; from about 350 to about 800 IU vitamin E,
preferably about 350 to about 450 IU vitamin E, and most preferably
about 400 IU vitamin E; from about 300 to about 1000 mg vitamin C,
preferably s about 350 to about 450 mg vitamin C, and most
preferably about 400 mg vitamin C; and from about 10 to less than
50 mg phytoestrogen, preferably about 12 to about 17 mg
phytoestroaen, and most preferably about 15 mg phytoestrogen.
[0056] The amounts of calcium, manganese, boron, copper, magnesium,
zinc and vitamin D are optimized to enhance calcium uptake and/or
utilization for the prevention of osteoporotic fractures; the
amounts of antioxidant, vitamin B.sub.12, vitamin B.sub.6, folic
acid, and chromium are maximized to prevent or reduce the risk of
CHD; phytoestrogens and antioxidants contribute to reducing the
risk of cardiovascular disease and some cancers.
[0057] A preferred Stage III daily dietary supplement is shown in
Table I.
1TABLE I DIETARY SUPPLEMENTS COMPONENT STAGE I STAGE II STAGE III
Calcium 200 mg 300 mg 400 mg Magnesium 100 mg 150 mg 200 mg Boron 1
mg 2 mg 3 mg Copper 1 mg 2 mg 3 mg Manganese 2 mg 3 mg 5 mg Zinc 10
mg 12 mg 15 mg Vitamin D 200 IU 300 IU 400 IU Iron 18 mg 15 mg 10
mg Folic Acid 400 .mu.g 400 .mu.g 400 .mu.g Vitamin B.sub.12 2
.mu.g 2 .mu.g 2 .mu.g Vitamin B.sub.6 50 mg 50 mg 1.6 mg Chromium
50 .mu.g 75 .mu.g 100 .mu.g Vitamin E 100 IU 200 IU 400 IU Vitamin
C 100 mg 200 mg 400 mg Phytoestrogen 10 mg 15 mg 15 mg
[0058] In a second aspect of the invention there is provided a
method for preventing or lessening the risk of life stage
associated diseases and health conditions in women by orally
administering a dietary supplement of this invention during the
appropriate life stage of the woman. For example, the Stage I
dietary supplement of this invention is orally administered to a
pre-perimenopausal woman, the Stage II dietary supplement is orally
administered to the woman when she reaches the perimenopausal and
menopausal stage and the Stage III dietary supplement of this
invention is administered to the woman when she reaches the
post-menopausal stage. In a preferred embodiment, the appropriate
dietary supplement is administered throughout at least one life
stage of the woman, most preferably throughout the three adult life
stages defined herein.
[0059] Although approximate age ranges for these stages are noted
above, any individual woman may have an accelerated course through
these phases. Delayed transitions can also occur but are less
likely. Thus, a woman taking the Stage I formulation who begins to
experience hot flashes, insomnia, or other menopausal symptoms
would benefit more from the Stage II formulation and should switch
to that formulation at whatever age those symptoms occur. It is
suggested that she remain on the Stage II formulation until she is
clearly post-menopausal as determined by medical convention
(generally an increased FSH--follicle stimulating hormone--and no
menstrual cycle for twelve months). The Stage III formulation is
then recommended.
[0060] Similarly, when a woman has had cessation of menses related
to decreased ovarian function as determined by medical convention,
she should switch from the Stage I to the Stage II formulation for
at least six months to one year, even though she has had no
distressing menopausal symptoms. When clearly through this
transition phase, the Stage III formulation is recommended due to
its additional preventive properties for post-menopausal
diseases.
[0061] And, a woman who undergoes surgical menopause at an early
age, e.g., at 35 years, no longer requires the Stage I formulation.
While the Stage II composition would not be inappropriate for a
year or two, the preferred formulation for this woman would be the
Stage III formulation because she has gone from a child-bearing
phase to a post-menopausal phase without a significant transition
period.
[0062] The present method for preventing or lessening the risk of
life stage associated health conditions is effective in the
prevention of fetal neural tube defects, prevention or reduction of
symptoms of PMS and menopause, prevention or reduction of the risk
of developing osteoporosis, iron deficiency anemia, coronary heart
disease, some cancers and cervical dysplasia.
[0063] In another aspect of the invention, there is provided a
dietary supplement formulated specifically for peri-menopausal and
menopausal women. The supplement may also be used by
pre-perimenopausal women to, for example, enhance the effects of
supplementation once the perimenopausal and menopausal life stage
is reached, or by post-menopausal women exhibiting residual
symptoms of menopause. Use during the pre-perimenopausal life
stages may also aid in regulating or may otherwise positively
impact the menstrual cycle.
[0064] The dietary supplement of this aspect of the invention is a
once daily supplement comprising physiologically effective
phytoestrogen in an amount of less than about 20 mg, preferably
less than about 15 mg and more preferably, less than about 14.5 mg
to about 1 mg.
[0065] The phytoestrogen to be used may be selected from
concentrated naturally-occurring phytoestrogen (such as whole
soybean extract), synthesized phytoestrogen, or mixtures thereof.
One or more different phytoestrogens may be included. Preferably,
the phytoestrogen is selected from the group consisting of
genistin, glycitin, daidzin, malonyl daidzin, malonyl genistin,
malonyl glycitin, acetyl glycitin, acetyl daidzin, acetyl genistin,
genistein, glycitein, daidzein and mixtures thereof.
[0066] The phytoestrogen may be derived from any suitable source,
for example, from a plant extract rich in phytoestrogens.
Preferably, the phytoestrogen is derived from whole soybean (as
opposed to soy germ). Other sources of phytoestrogen however may be
utilized. The phytoestrogens may be glycosylated, such as genistin,
glycitin or daidzin, malonyl daidzin, malonyl genistin, malonyl
glycitin, acetyl glycitin, acetyl daidzin, acetyl genistin, or
non-glycosylated, such as genistein, glycitein or daidzein.
Preferably, the phytoestrogen has the following phytoestrogen
profile (by weight percent): about 31 to 35% daidzin, about 8 to
10% glycitin, about 36 to 40% genistin, about 3 to 5% malonyl
daidzin, about 0.5 to 2.5% malonyl glycitin, about 2.6 to 4.6%
malonyl genistin, about 3.7 to 5.7% acetyl daidzin, about 0.1 to
1.1% acetyl glycitin, about 3.2 to 5.2% acetyl genistin, about 0.1
to 1 daidzein, about 0.1 to 1% glycitein, and about 0.1 to 0.9%
genistein. Most preferably the phytoestrogen has a phytoestrogen
profile similar to that described in Table II, which sets forth the
phytoestrogen profile for total phytoestrogens in a phytoestrogen
concentrate derived from whole soybean.
[0067] The dietary supplement may be provided in tablet, patch.
gel, cream or capsule form, for example or formulated in a
palatable confection such as a confectionary bar, beverage, cereal,
powder, chewing gum and the like.
[0068] In a preferred embodiment, there is provided a once daily
dietary supplement containing a mixture of daidzin, glycitin,
genistin, malonyl daidzin, malonyl genistin, malonyl glycitin,
acetyl glycitin, acetyl daidzin, acetyl genistin, genistein,
glycitein and daidzein in a total weight amount of about 10 to
about 15 mg, more preferably 13 to 15 mg. Preferably, each of the
phytoestrogens is provided in the following percentages (by weight)
of the total phytoestrogens: about 33% daidzin, about about 9%
glycitin, about 38% genistin, about 4% malonyl daidzin, about 1.5%
malonyl glycitin, about 3.6% malonyl genistin, about 4.7% acetyl
daidzin, about 0.6% acetyl glycitin, about 4.2% acetyl genistin,
about 0.5% daidzein, about 0.5% glycitein, and about 0.4%
genistein.
[0069] In a most preferred embodiment, a supplement is provided
using about 50 mg of soybean phytoestrogen s concentrate having the
phytoestrogen profile set forth in Table II, to give a
phytoestrogen content of 14.15. This tablet provides phytoestrogens
in the following forms and amounts: about 4.726 mg daidzin, about
1.257 mg glycitin, about 5.312 mg genistin, about 0.586 mg malonyl
daidzin, about 0.217 mg malonyl glycitin, about 0.510 mg malonyl
genistin, about 0.670 mg acetyl daidzin, about 0.082 mg acetyl
glycitin, about 0.595 mg acetyl genistin, about 0.076 mg daidzein,
about 0.062 mg glycitein, and about 0.060 mg genistein (See Table
II).
2TABLE II PHYTOESTROGEN SUPPLEMENT mg/50 mg of ppm (.mu.g/g) in
whole soybean whole soybean phytoestrogen phytoestrogen
PHYTOESTROGEN wt % concentrate concentrate Daidzin 33 4.726 94527
Glycitin 9 1.257 25144 Genistin 38 5.312 106239 Malonyl Daidzin 4
0.586 11721 Malonyl Glycitin 1.5 0.217 4341 Malonyl Genistin 3.6
0.510 10200 Acetyl Daidzin 4.7 0.670 13390 Acetyl Glycitin 0.6
0.082 1633 Acetyl Genistin 4.2 0.595 11907 Daidzein 0.5 0.076 1510
Glycitein 0.5 0.062 1243 Genistein 0.4 0.060 1192 TOTAL 100 14.15
283047
EXAMPLE 1
[0070] The diet of a pre-perimenopausal woman is supplemented daily
with the Stage I dietary supplement of this invention. The dietary
supplement is administered in tablet form formulated for once daily
administration. Supplementation of the diet is carried out
throughout the entire pre-perimenopausal life stage.
[0071] When the woman reaches the perimenopausal life stage,
dietary supplementation is changed from the Stage I to Stage II
dietary supplement of the invention. The Stage II dietary
supplement is administered in the same manner as is the Stage I
supplement. Dietary supplementation continues throughout
perimenopause and menopause, after which the Stage III dietary
supplement is administered in place of the Stage II supplement.
EXAMPLE 2
[0072] The diet of two menopausal women who were unable or
unwilling to take hormonal replacement therapy (HRT) and who
presented with menopausal symptoms including hot flashes, insomnia
and night sweats that were marked to severe in quantity and/or
quality was supplemented with a dietary regimen of about 15 mg/day
phytoestrogen. Both women had been on HRT in the past (one woman
for two and one half months and the other for two years). However,
neither woman would consider its continued use. Both women had also
tried alternative treatment regimens, such as acupuncture and
Chinese herbs with little or no lasting relief.
[0073] Both women reported immediate relief (within several days)
upon taking tablets containing about 15 mg/day of phytoestrogen.
The effect got progressively better for four to six weeks at which
time a plateau was reached. Each woman reported a significant
reduction in hot flashes, i.e., from more than twenty per day to
less than five per day, as well as a reduction in their intensity
(from "hot" to "warm flushes"). Night sweats were also
significantly reduced and both the duration and quality of sleep
improved.
[0074] A SMAC-18 laboratory analysis was obtained for each woman
prior to the start of phytoestrogen therapy and again at four to
six weeks and at eight to thirteen weeks after onset of
phytoestrogen therapy. There were no adverse changes in the SMAC-18
data. Specifically, kidney function and liver enzyme levels
remained unchanged.
[0075] As a comparison, at least one of the women was provided with
a phytoestrogen supplement already on the is market to substitute
for the phytoestrogen supplement of the invention. She reported
that it was completely unsatisfactory.
* * * * *