U.S. patent application number 12/301723 was filed with the patent office on 2009-06-04 for maternal supplement.
This patent application is currently assigned to NESTEC S.A.. Invention is credited to Ferdinand Haschke, Zdenek Kratky.
Application Number | 20090142314 12/301723 |
Document ID | / |
Family ID | 36758415 |
Filed Date | 2009-06-04 |
United States Patent
Application |
20090142314 |
Kind Code |
A1 |
Haschke; Ferdinand ; et
al. |
June 4, 2009 |
MATERNAL SUPPLEMENT
Abstract
The use of docosahexaenoic acid in the manufacture of a
composition for administration to a pregnant woman for reducing the
risk of development of overweight or obesity of the baby in infancy
and/or early childhood.
Inventors: |
Haschke; Ferdinand; (La
Tour-de-Peilz, CH) ; Kratky; Zdenek; (New Milford,
CT) |
Correspondence
Address: |
K&L Gates LLP
P.O. Box 1135
CHICAGO
IL
60690
US
|
Assignee: |
NESTEC S.A.
Vevey
CH
|
Family ID: |
36758415 |
Appl. No.: |
12/301723 |
Filed: |
May 22, 2007 |
PCT Filed: |
May 22, 2007 |
PCT NO: |
PCT/EP2007/054916 |
371 Date: |
November 20, 2008 |
Current U.S.
Class: |
424/93.45 ;
424/601; 424/638; 424/641; 424/646; 424/667; 424/682; 424/702;
424/93.4; 514/249; 514/251; 514/474; 514/52; 514/54; 514/560 |
Current CPC
Class: |
A61P 3/02 20180101; A61P
31/04 20180101; A61P 3/04 20180101; A61K 31/202 20130101 |
Class at
Publication: |
424/93.45 ;
514/560; 514/54; 424/682; 424/601; 424/646; 424/641; 424/638;
424/667; 424/702; 514/474; 514/52; 514/251; 514/249; 424/93.4 |
International
Class: |
A61K 31/202 20060101
A61K031/202; A61K 31/715 20060101 A61K031/715; A61K 33/06 20060101
A61K033/06; A61K 33/42 20060101 A61K033/42; A61K 33/26 20060101
A61K033/26; A61K 33/30 20060101 A61K033/30; A61K 33/34 20060101
A61K033/34; A61K 33/18 20060101 A61K033/18; A61K 33/04 20060101
A61K033/04; A61K 31/375 20060101 A61K031/375; A61K 31/714 20060101
A61K031/714; A61K 31/525 20060101 A61K031/525; A61K 31/519 20060101
A61K031/519; A61K 35/74 20060101 A61K035/74; A61P 31/04 20060101
A61P031/04 |
Foreign Application Data
Date |
Code |
Application Number |
May 23, 2006 |
EP |
06114360.8 |
Claims
1. A method for reducing the risk of development of overweight or
obesity of a baby in infancy and/or early childhood comprising the
steps of administering a composition comprising docosahexaenoic
acid to a newborn baby for a period not exceeding three months.
2. The method of claim 1, wherein the composition is administered
to the baby via a breast feeding mother.
3. The method of claim 1, wherein the composition is administered
directly to the baby.
4. A method for reducing the risk of development of overweight or
obesity of a baby in infancy and/or early childhood comprising the
steps of administering a composition comprising docosahexaenoic
acid to a pregnant woman.
5. The method of claim 4, wherein the composition comprises from
100 to 500 mg of docosahexaenoic acid per daily dose.
6. The method of claim 4, wherein the composition comprises from 2
to 8 g of dietary fibre per daily dose.
7. The use of claim 6, wherein the dietary fibre is a mixture of
short and long chain fructo-oligosaccharides produced by the
hydrolysis of inulin.
8. The method of claim 1 wherein the composition comprises one or
more of the micronutrients selected from the group consisting of,
in the ranges given:- 300 to 500 mg calcium, 50 to 100 mg
magnesium, 150 to 250 mg phosphorus, 5 to 20 mg iron, 1 to 7 mg
zinc, 0.1 to 0.3 mg copper, 50 to 200 .mu.g iodine, 5 to 15 .mu.g
selenium, 1000 to 3000 .mu.g beta carotene, 10 to 80 mg Vitamin C,
1 to 2 mg Vitamin B1, 0.5 to 1.5 mg Vitamin B6, 0.5 to 2 mg Vitamin
B2, 5 to 18 mg niacin, 0.5 to 2.0 .mu.g Vitamin B12, 100 to 800
.mu.g folic acid, 30 to 70 .mu.g biotin, 1 to 5 .mu.g Vitamin D,
and 3 to 10 IU Vitamin E.
9. The method of claim 4 wherein the composition comprises a
probiotic bacterial strain.
10. The use of claim 9, wherein the probiotic bacterial strain is
Lactobacillus rhamnosus CGMCC 1.3724.
11. The method of claim 1, wherein the composition comprises from
100 to 500 mg of docosahexaenoic acid per daily dose.
12. The method of claim 1, wherein the composition comprises from 2
to 8 g of dietary fibre per daily dose.
13. The method of claim 12, wherein the dietary fibre is a mixture
of short and long chain fructo-oligosaccharides produced by the
hydrolysis of inulin.
14. The method of claim 1 wherein the composition comprises one or
more of the micronutrients selected from the group consisting of,
in the ranges given: 300 to 500 mg calcium, 50 to 100 mg magnesium,
150 to 250 mg phosphorus, 5 to 20 mg iron, 1 to 7 mg zinc, 0.1 to
0.3 mg copper, 50 to 200 .mu.g iodine, 5 to 15 .mu.g selenium, 1000
to 3000 .mu.g beta carotene, 10 to 80 mg Vitamin C, 1 to 2 mg
Vitamin B1, 0.5 to 1.5 mg Vitamin B6, 0.5 to 2 mg Vitamin B2, 5 to
18 mg niacin, 0.5 to 2.0 .mu.g Vitamin B12, 100 to 800 .mu.g folic
acid, 30 to 70 .mu.g biotin, 1 to 5 .mu.g Vitamin D, and 3 to 10 IU
Vitamin E.
15. The method of claim 1 wherein the composition additionally
comprises a probiotic bacterial strain.
16. The method of claim 15 wherein the composition additionally
comprises a probiotic bacterial strain.
17. The method of claim 16, wherein the probiotic bacterial strain
is Lactobacillus rhamnosus CGMCC 1.3724.
18. A method for reducing the risk of development of overweight or
obesity in a baby comprising the steps of administering a
composition comprising docosahexaenoic acid to a pregnant woman in
at least the third trimester of pregnancy.
19. he method of claim 18, wherein the composition comprises from
100 to 500 mg of docosahexaenoic acid per daily dose.
20. The method of claim 18, wherein the composition comprises from
2 to 8 g of dietary fibre per daily dose.
21. The method of claim 18, wherein the dietary fibre is a mixture
of short and long chain fructo-oligosaccharides produced by the
hydrolysis of inulin.
22. The method of claim 18 wherein the composition comprises one or
more of the micronutrients selected from the group consisting of,
in the ranges given: 300 to 500 mg calcium, 50 to 100 mg magnesium,
150 to 250 mg phosphorus, 5 to 20 mg iron, 1 to 7 mg zinc, 0.1 to
0.3 mg copper, 50 to 200 .mu.g iodine, 5 to 15 .mu.g selenium, 1000
to 3000 .mu.g beta carotene, 10 to 80 mg Vitamin C, 1 to 2 mg
Vitamin B1, 0.5 to 1.5 mg Vitamin B6, 0.5 to 2 mg Vitamin B2, 5 to
18 mg niacin, 0.5 to 2.0 .mu.g Vitamin B12, 100 to 800 .mu.g folic
acid, 30 to 70 .mu.g biotin, 1 to 5 .mu.g Vitamin D, and 3 to 10 IU
Vitamin E.
23. The method of claim 18, wherein the composition additionally
comprises a probiotic bacterial strain.
24. The method of claim 23, wherein the probiotic bacterial strain
is Lactobacillus rhamnosus CGMCC 1.3724.
25. A method for production of a composition for administration to
a pregnant woman for reducing the risk of development of overweight
or obesity of the baby in infancy and/or early childhood comprising
the step of using docosahexaenoic acid to produce the composition.
Description
FIELD OF THE INVENTION
[0001] This invention relates to a nutritional supplement for
pregnant women to reduce the risk of obesity of the baby in later
life.
BACKGROUND TO THE INVENTION
[0002] Scientific literature suggests that supplementation of
infant formula with the long chain polyunsaturated fatty acids
(LC-PUFA) docosahexaenoic acid (DHA, omega 3) and arachidonic acid
(ARA, omega 6) may have many health benefits for the infant. Indeed
it has been demonstrated that in pre-term infants receiving DHA and
ARA either from breast milk or infant formula containing these
LC-PUFA demonstrate improved cognitive abilities, visual acuity and
motor skills when compared with unsupplemented pre-term infants.
The picture for term infants is less clear. Some studies have been
published showing similar benefits of supplementation to those
demonstrated with pre-term infants but other studies have found no
effect of supplementation.
[0003] It has been suggested that these conflicting results with
term infants could be due to the influence of maternal LC-PUFA
status. DHA in particular is accumulated preferentially to other
fatty acids by the foetus in the last trimester of pregnancy. In
premature birth, this period does not last the full three months
and it may be expected that the response of the pre-term infant to
supplementation with DHA would be marked. A term infant, however,
would have the benefit of maternal supply during the last three
months of gestation and, assuming that supply to be adequate, could
be expected to have adequate or near adequate DHA status at
birth.
[0004] However, in the developed world at least, there are
increasing concerns over the physiological effects of a diet rich
in saturated fats and favouring the precursors of omega 6 LC-PUFA
such as ARA at the expense of the precursors of omega 3 LC-PUFA
such as DHA on the physiological omega 6:omega 3 ratio in general.
In particular, there are concerns that pregnant women eating a
normal Western diet may not be able to supply sufficient omega 3
precursors to meet the developing foetus's need to synthesise DHA.
For this reason it has been proposed for example in WO 2003/017945
to develop a range of supplements for pregnant women containing DHA
with ARA and various vitamins and minerals. It is claimed that
taking such supplements could benefit the health of both mother and
baby. Examples of possible benefits to the unborn baby are stated
to include optimised growth and development of the nervous system
and improved foetal weight gain.
[0005] The prevalence of obesity in adults, adolescents and
children has increased rapidly and research to identify approaches
to prevent overweight and obesity in childhood is considered to be
of major public health importance. Overweight and obesity in
childhood is a relatively recent phenomenon that already affects
over 15 million children under age 5 across the world. Almost 30%
of adolescents and children in the US and between 10 and 30% of
children in Europe may be classified as overweight or obese. It has
been suggested that rapid growth during the first four months of
life may be associated with the development of overweight or
obesity later in life and that the rate of weight gain in the first
few weeks of life may be particularly important.
[0006] Recently, attention has focused on the possible role of
LC-PUFA in the development and treatment of overweight and obesity.
For example, WO 2004/012727 discloses a method for decreasing the
appetite of a mammal comprising enterally administering an omega 3
LC-PUFA to the mammal. Ruzickova J. et al. (Lipids. 2004
Dec;39(12): 1177-85) document augmentation of the antiadipogenic
effect of EPA/DHA during development of obesity and suggest that
EPA/DHA could reduce accumulation of body fat by limiting both
hypertrophy and hyperplasia of fat cells.
[0007] However, Lauritzen L. et al. (Maternal fish oil
supplementation in lactation and growth during the first 2.5 years
of life. Pediatr Res. 2005 Aug;58(2):235-42) performed a randomized
trial on mothers after delivery. The women were randomly assigned
to take a supplement of fish oil (rich in omega 3 LC-PUFA such as
DHA) or olive oil. The supplement was taken during 0 to 4 months of
lactation. 122 children were studied of whom 70 were followed up
until 30 months. The BMI of the children was measured at birth and
at 2, 4, 9 and 30 months of age. The results showed that the BMI of
infants in the fish oil group was higher than the BMI of infants in
the olive oil group from the age of 9 months on.
[0008] There remains a need to provide alternative methods to
address the risk of overweight and obesity, particularly during
childhood.
SUMMARY OF THE INVENTION
[0009] The inventors have conducted a study investigating the
effect of a daily oral supplement containing DHA on red blood cell
phospholipid DHA concentration in pregnant women at 37 weeks of
gestation and whether a daily oral intake of DHA influences the DHA
concentrations in breast-milk or/and red blood cell phospholipids
in mother and/or infant during lactation. During this study, it was
surprisingly found that the weight and body mass index of children
in the DHA supplemented group at age 21 months were significantly
lower than the weight and body mass index of children in the group
not receiving DHA.
[0010] Accordingly, in a first aspect the present invention
provides the use of docosahexaenoic acid in the manufacture of a
composition for administration to a pregnant woman in at least the
third trimester of pregnancy and, after delivery, to the newborn
baby for a period not exceeding three months for reducing the risk
of development of overweight or obesity of the baby in infancy
and/or early childhood.
[0011] In a second aspect, the present invention provides the use
of docosahexaenoic acid in the manufacture of a composition for
administration to a pregnant woman for reducing the risk of
development of overweight or obesity of the baby in infancy and/or
early childhood.
[0012] In a third aspect, the present invention provides the use of
docosahexaenoic acid in the manufacture of a composition for
administration to a pregnant women to promote the development of
lean body mass of the baby in infancy and/or early childhood.
[0013] The invention extends to a method of reducing the risk of
obesity of a baby in infancy and/or early childhood by providing to
a pregnant woman in need thereof a composition containing a
therapeutic amount of docosahexaenoic acid.
[0014] The invention further extends to a method of promoting the
development of lean body mass of a baby in infancy and/or early
childhood by providing to a pregnant woman in need thereof a
composition containing a therapeutic amount of docosahexaenoic
acid.
[0015] If supplementation with DHA is continued after delivery, the
composition may either be administered to the infant via the breast
feeding mother or may be administered directly to the infant.
DETAILED DESCRIPTION OF THE INVENTION
[0016] In this specification, the following terms have the
following meanings:- [0017] "body mass index " or "BMI" means the
ratio of weight in Kg divided by the height in metres, squared.
[0018] "infancy and early childhood" means the first six years of
life [0019] "overweight" is defined as having a BMI between 25 and
30 [0020] "obese" is defined as having a BMI greater than 30
[0021] All references to percentages are percentages by weight
unless otherwise stated.
[0022] The daily dose of DHA for a pregnant woman is preferably
between 100 and 500 mg, more preferably between 200 and 400 mg. The
amount of DHA in the composition may thus be selected accordingly
depending upon whether it is intended to be consumed once a day or
more frequently. For example, a composition intended to be consumed
once a day may contain 200 mg of DHA.
[0023] Suitable sources of DHA include fish oil and biomass
obtained from the culture of a suitable micro-organism such as
Crypthecodium cohnii. The composition is preferably taken
throughout pregnancy to build up maternal stores of DHA although
supplementation in the second and more particularly the third
trimesters is believed to be particularly advantageous. Likewise
supplementation may continue after birth either via continued
consumption of the composition by the mother if the baby is to be
breast fed or by administering DHA to the baby, for example by
including DHA in the infant formula used to feed the baby. A
suitable DHA content in infant formula ranges between 0.2 and 0.8%
by weight of total fatty acids in the formula.
[0024] In one embodiment, the composition is a nutritional
composition. The composition may be a nutritionally complete
formula, a nutritional supplement, a food product such as a dairy
product, a chilled or shelf stable beverage or a soup, a dietary
supplement, a meal replacement, or a nutritional bar for
example.
[0025] A nutritionally complete formula for use according to the
invention may comprise a source of protein. Any suitable dietary
protein may be used for example animal proteins (such as milk
proteins, meat proteins and egg proteins); vegetable proteins (such
as soy protein, wheat protein, rice protein, and pea protein);
mixtures of free amino acids; or combinations thereof. Milk
proteins such as casein and whey, and soy proteins are particularly
preferred. The composition may also contain a source of
carbohydrates and a source of fat.
[0026] If the formula includes a fat source in addition to the DHA,
the fat source preferably provides 5% to 40% of the energy of the
formula; for example 20% to 30% of the energy. A suitable fat
profile may be obtained using a blend of canola oil, corn oil and
high-oleic acid sunflower oil.
[0027] A source of carbohydrate may be added to the formula. It
preferably provides 40% to 80% of the energy of the formula. Any
suitable carbohydrate may be used, for example sucrose, lactose,
glucose, fructose, corn syrup solids, maltodextrins, and mixtures
thereof. Dietary fibre may also be added if desired. Dietary fibre
passes through the small intestine undigested by enzymes and
functions as a natural bulking agent and laxative. Dietary fibre
may be soluble or insoluble and in general a blend of the two types
is preferred. Suitable sources of dietary fibre include soy, pea,
oat, pectin, guar gum, gum Arabic, fructooligosaccharides,
galacto-oligosaccharides, sialyl-lactose and oligosaccharides
derived from animal milks. A preferred fibre blend is a mixture of
inulin with shorter chain fructo-oligosaccharides. Preferably, if
fibre is present, the fibre content is between 10 and 40 g/l of the
formula as consumed.
[0028] The formula may also contain minerals and micronutrients
such as trace elements and vitamins in accordance with the
recommendations of Government bodies such as the USRDA. For
example, the formula may contain per daily dose one or more of the
following micronutrients in the ranges given:- 300 to 500 mg
calcium, 50 to 100 mg magnesium, 150 to 250 mg phosphorus, 5 to 20
mg iron, 1 to 7 mg zinc, 0.1 to 0.3 mg copper, 50 to 200 .mu.g
iodine, 5 to 15 .mu.g selenium, 1000 to 3000 .mu.g beta carotene,
10 to 80 mg Vitamin C, 1 to 2 mg Vitamin B1, 0.5 to 1.5 mg Vitamin
B6, 0.5 to 2 mg Vitamin B2, 5 to 18 mg niacin, 0.5 to 2.0 .mu.g
Vitamin B12, 100 to 800 .mu.g folic acid, 30 to 70 .mu.g biotin, 1
to 5 .mu.g Vitamin D, 3 to 10 IU Vitamin E.
[0029] A probiotic bacterial strain may be added to the formula.
One example of a suitable strain is Lactobacillus rhamnosus CGMCC
1.3724.
[0030] One or more food grade emulsifiers may be incorporated into
the formula if desired; for example diacetyl tartaric acid esters
of mono- and di- glycerides, lecithin and mono- and di-glycerides.
Similarly suitable salts and stabilisers may be included.
[0031] The formula is preferably enterally administrable; for
example in the form of a powder or a liquid concentrate for
re-constitution with milk or water, a solid product or a
ready-to-drink beverage.
[0032] The formula may be prepared in any suitable manner. For
example, it may be prepared by blending together the protein, the
carbohydrate source, and the fat source including the DHA in
appropriate proportions. If used, the emulsifiers may be included
at this point. The vitamins and minerals may be added at this point
but are usually added later to avoid thermal degradation. Any
lipophilic vitamins, emulsifiers and the like may be dissolved into
the fat source prior to blending. Water, preferably water which has
been subjected to reverse osmosis, may then be mixed in to form a
liquid mixture. The temperature of the water is conveniently about
50.degree. C. to about 80.degree. C. to aid dispersal of the
ingredients. Commercially available liquefiers may be used to form
the liquid mixture. The liquid mixture is then homogenised; for
example in two stages.
[0033] The liquid mixture may then be thermally treated to reduce
bacterial loads, by rapidly heating the liquid mixture to a
temperature in the range of about 80.degree. C. to about
150.degree. C. for about 5 seconds to about 5 minutes, for example.
This may be carried out by steam injection, autoclave or by heat
exchanger; for example a plate heat exchanger.
[0034] Then, the liquid mixture may be cooled to about 60.degree.
C. to about 85.degree. C.; for example by flash cooling. The liquid
mixture may then be again homogenised; for example in two stages at
about 10 MPa to about 30 MPa in the first stage and about 2 MPa to
about 10 MPa in the second stage. The homogenised mixture may then
be further cooled to add any heat sensitive components; such as
vitamins and minerals. The pH and solids content of the homogenised
mixture are conveniently adjusted at this point.
[0035] If it is desired to produce a powdered formula, the
homogenised mixture is transferred to a suitable drying apparatus
such as a spray drier or freeze drier and converted to powder. The
powder should have a moisture content of less than about 5% by
weight.
[0036] If it is desired to produce a liquid formula, the
homogenised mixture is preferably aseptically filled into suitable
containers by pre-heating the homogenised mixture (for example to
about 75 to 85.degree. C.) and then injecting steam into the
homogenised mixture to raise the temperature to about 140 to
160.degree. C.; for example at about 150.degree. C. The homogenised
mixture may then be cooled, for example by flash cooling, to a
temperature of about 75 to 85.degree. C. The homogenised mixture
may then be homogenised, further cooled to about room temperature
and filled into containers. Suitable apparatus for carrying out
aseptic filling of this nature is commercially available. The
liquid composition may be in the form of a ready to feed formula
having a solids content of about 10 to about 14% by weight or may
be in the form of a concentrate; usually of solids content of about
20 to about 26% by weight.
[0037] In another embodiment, a conventional food product such as a
yoghurt, or a breakfast cereal may be enriched with the DHA.
[0038] In yet a further embodiment, a supplement containing DHA in
an amount sufficient to achieve the desired effect in an individual
can be prepared. This supplement may be in the form of tablets,
capsules, pastilles or a liquid for example. The supplement may
further contain protective hydrocolloids (such as gums, proteins,
modified starches), binders, film forming agents, encapsulating
agents/materials, wall/shell materials, matrix compounds, coatings,
emulsifiers, surface active agents, solubilizing agents (oils,
fats, waxes, lecithins etc.), adsorbents, carriers, fillers,
co-compounds, dispersing agents, wetting agents, processing aids
(solvents), flowing agents, taste masking agents, weighting agents,
jellifying agents, gel forming agents, antioxidants and
antimicrobials. The supplement may also contain conventional
pharmaceutical additives and adjuvants, excipients and diluents,
including, but not limited to, water, gelatine of any origin,
vegetable gums, ligninsulfonate, talc, sugars, starch, gum arabic,
vegetable oils, polyalkylene glycols, flavouring agents,
preservatives, stabilizers, emulsifying agents, buffers,
lubricants, colorants, wetting agents, fillers, and the like.
[0039] Further, the supplement may contain an organic or inorganic
carrier material suitable for oral or enteral administration as
well as vitamins, minerals trace elements and other micronutrients
in accordance with the recommendations of Government bodies such as
the USRDA. For example, the supplement may contain one or more of
the following micronutrients in the ranges given:- 300 to 500 mg
calcium, 50 to 100 mg magnesium, 150 to 250 mg phosphorus, 5 to 20
mg iron, 1 to 7 mg zinc, 0.1 to 0.3 mg copper, 50 to 200 jig
iodine, 5 to 15 .mu.g selenium, 1000 to 3000 .mu.g beta carotene,
10 to 80 mg Vitamin C, 1 to 2 mg Vitamin B1, 0.5 to 1.5 mg Vitamin
B6, 0.5 to 2 mg Vitamin B2, 5 to 18 mg niacin, 0.5 to 2.0 .mu.g
Vitamin B12, 100 to 800 .mu.g folic acid, 30 to 70 .mu.g biotin, 1
to 5 .mu.g Vitamin D, 3 to 10 IU Vitamin E.
[0040] The invention will now be further illustrated by reference
to the following examples:-
EXAMPLE 1
[0041] An example of a shelf stable liquid nutritional supplement
to be used according to the present invention is as follows:-
TABLE-US-00001 Per 100 g ready Per serving Per 100 kcal to drink
(190 ml) Energy (kcal) 100 65 130 Fat (g) 0.92 0.60 1.20 DHA (mg)
200 130 260 (from fish oil) Protein (g) 3.54 2.30 4.60 Carbohydrate
(g) 19.4 12.60 25.2 Dietary fibre (g) 3.62 2.35 4.70 Minerals
Sodium (mg) 51 33 66 Potassium (mg) 238 155 310 Chloride (mg) 123
80 160 Calcium (mg) 308 200 400 Phosphorus (mg) 162 105 210
Magnesium (mg) 58.0 38 76 Selenium (.mu.g) 7.7 5.0 10.0 Vitamins
Beta carotene (.mu.g) 1600 1050 2100 Vitamin D (.mu.g) 3.8 2.50 5.0
Vitamin E (IU) 4.6 3.0 6.0 Vitamin C (mg) 38 25 50 Vitamin B1 (mg)
1.2 0.75 1.5 Vitamin B2 (mg) 1.3 0.85 1.7 Niacin (mg) 12 8 16
Vitamin B6 (mg) 1.1 0.7 1.4 Folic acid (.mu.g) 310 200 400 Vitamin
B12 (.mu.g) 1.2 0.75 1.5 Biotin (.mu.g) 54 35 70 Trace Elements
Iron (mg) 12 7.5 15 Iodine (.mu.g) 150 100 200 Copper (mg) 0.20
0.13 0.26 Zinc (mg) 3.8 2.5 5.0
EXAMPLE 2
[0042] This example compares the effect of administering a
nutritional supplement including DHA to pregnant women with the
effect of administration of the same supplement but without the DHA
to a comparable group of pregnant women on the evolution of weight
and body mass of their children.
[0043] A randomised, controlled, double blind, single centre
clinical trial was carried out at Klinik fur Geburtsmedizin,
Charite, Campus Virchow Klinikum, Berlin, Germany. The study was
carried out according to the principles and rules laid down in the
Declaration of Helsinki (as amended). A total of 144 healthy adult
Caucasian non-smoking women in the 20.sup.th to 22.sup.nd week of
pregnancy willing to breastfeed for at least 3 months were
recruited and assigned to one of three treatment groups. Subjects
in all three groups received a daily nutritional supplement with
the only difference being the content of the supplement as
follows:- [0044] Group 1: Supplement (Vitamins, Minerals) [0045]
Group 2: Supplement (Vitamins, Minerals +prebiotic) [0046] Group 3:
Supplement (Vitamins, Minerals +prebiotic +DHA as per Example
1)
[0047] All supplements were in the form of a shelf-stable liquid
containing per serving 4.6 g protein and 25 g carbohydrate,
vitamins and minerals. In addition, the supplement for Groups 2 and
3 contained 3.8 g per serving of a mixture of short and long chain
fructo-oligosaccharides produced by the hydrolysis of inulin and
the supplement for Group 3 contained 0.26 g per serving DHA. 190 ml
of the supplement was taken per day in all groups delivering 120
kcal for Groups 1 and 2 and 130 kcal for Group 3. The supplement
was taken for the remainder of the pregnancy and for the first
three months of lactation.
[0048] All supplements were supplied to the hospital blinded and
distinguishable only by three different colours of the label. The
colour code was known only to the manufacturer.
[0049] Daily consumption of the supplements was recorded by the
subjects in a booklet. Compliance was checked every six weeks by
telephone call and the consumption record was brought to the
hospital at each visit. No other nutritional supplements were taken
during the study period.
[0050] Inter alia, the following outcomes were measured:- [0051]
red blood cell phospholipid DHA concentration in pregnant women at
week 37 of pregnancy and in babies at 1 and 3 months of age; [0052]
DHA concentration in breastmilk of lactating mothers three months
after birth; [0053] Anthropometric values (length, weight, BMI and
head circumference)of the babies at one, three and twenty-one
months of age.
[0054] Of the 144 pregnant women enrolled in the trial, 116 babies
remained in the study until the age of 3 months and 69 until the
age of 21 months.
[0055] It was found that the DHA concentration as a % of total
fatty acids at 3 months in breastmilk in Group 1 subjects was 0.25
(+/-0.10) compared to 0.26 (+/-0.13), and 0.50 (+/-0.19) in Group 2
and Group 3 subjects, respectively. The treatment effect was
significant in Group 3 compared to Groups 1 and 2. The red blood
cell DHA concentration (% of total fatty acids) at 3 months in
babies in Group 1 was 7.49 (+/-2.00) compared to 6.88 (+/-2.76) in
Group 2, and 9.79 (+/-2.21) in Group 3. Again, the treatment
effects were significantly different. Furthermore, the omega
6:omega 3 ratio in the red blood cells of the women in Groups 1 and
2 was 2:1 compared to 1.55:1 for the women in Group 3. Likewise,
the omega 6:omega 3 ratio in breastmilk of the women in Groups 1
and 2 was also 2:1 compared to 0.85:1 for the women in Group 3 and
the omega 6:omega 3 ratio in the red blood cells of the babies in
Groups 1 and 2 at 3 months of age was 2.4:1 compared to 1.6:1 for
the babies of women in Group 3 at the same age.
[0056] At birth, anthropometric values were nearly identical in all
groups. But a significant time dependent effect was observed for
babies from Group 3 in weight (p=0.049) and BMI (p=0.044), when
taking into account sex, gestational and chronological age of the
baby, the mother's education, parity, BMI, gestational weight gain
and breast feeding. After controlling for all influential
variables, 21 month old children from Group 3 were found to have a
significantly lower weight (0.6kg less, p=0.006) and BMI (0.77
less, p=0.031) than children in Groups 1 and 2 while head
circumference was slightly larger in Group 3 and length was similar
in all groups. As body length is a recognised indicator for lean
body mass, it can therefore be said that children from Group 3
having a lower weight and BMI than children from Groups 1 and 2 but
similar length have a leaner body mass than children from Groups 1
and 2.
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