Comparison of the effects of cows• milk, fortified soy milk, and calcium supplement on weight and fat loss in premenopausal overweight and obese women
Nutrition, Metabolism & Cardiovascular Diseases (2009) xx, 1e5
a v a i l a b l e a t w w w . s c i e n c e d i r e c t . c o m
Comparison of the effects of cows’ milk, fortifiedsoy milk, and calcium supplement on weightand fat loss in premenopausal overweight andobese women
Sh Faghih , A.R. Abadi , M. Hedayati S.M. Kimiagar
a Department of Nutrition, Faculty of Nutrition Sciences and Food Technology, Arghavan Ave, Farahzadi Bulv, Tehran, Iranb Department of Statistics, Faculty of Medicine, Evin, Tehran, Iranc Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences,Parvaneh Ave, Chamran Expressway, Tehran, Iran
Received 17 July 2009; received in revised form 17 November 2009; accepted 28 November 2009
Background and aims: Recent studies suggest that calcium metabolism and perhaps
other components of dairy products may contribute to shifting the energy balance and thus
play a role in weight regulation. We compared the effects of cows’ milk, calcium fortified
soy milk and calcium supplement on weight and body fat reduction in premenopausal over-
weight and obese women. Methods and Results: In this clinical trial, 100 healthy overweight or obese premenopausalwomen were randomized to one of the following dietary regimens for 8 weeks: (1) a control dietproviding a 500 kcal/day deficit, with 500e600 mg/day dietary calcium; (2) a calcium-supplemen-ted diet identical to the control diet with 800 mg/day of calcium as calcium carbonate; (3) a milkdiet providing a 500 kcal/day deficit and containing three servings of low-fat milk; (4) a soymilk diet providing a 500 kcal/day deficit and containing three servings of calcium fortified soymilk. At baseline and after 8 weeks, weight, waist circumference, and hip circumference weremeasured. Three 24-h dietary records and physical activity records were also taken. Comparingthe mean differences in weight, waist circumference, body mass index (BMI) and waist-to-hip ratio(WHR) using repeated measure of variance analysis showed that changes in waist circumferenceand WHR were significant among the four groups (p Z 0.029 and p Z 0.015, respectively). Afteradjustment for baseline values, changes in weight and BMI were also significant (p Z 0.017 andp Z 0.019, respectively). Weight reductions in high milk, soy milk, calcium supplement andcontrol groups were 4.43 Æ 1.93 (kg), 3.46 Æ 1.28 (kg), 3.89 Æ 2.40 (kg) and 2.87 Æ 1.55 (kg),respectively. The greatest changes were seen in the high dairy group in all variables.
* Corresponding author. Tel.: þ98 2122357484.
E-mail addresses: (S. Faghih), (A.R. Abadi), (M. Hedayati),
0939-4753/$ - see front matter ª 2009 Published by Elsevier B.V. doi:10.1016/j.numecd.2009.11.013
Please cite this article in press as: Faghih S, et al., Comparison of the effects of cows’ milk, fortified soy milk, and calcium supplement onweight and fat loss in premenopausal overweight and obese women, Nutr Metab Cardiovasc Dis (2009), doi:10.1016/j.numecd.2009.11.013
Conclusion: Increasing low fat milk consumption significantly reduces the general and centralobesity beyond a low calorie diet. ª 2009 Published by Elsevier B.V.
Obesity is recognized as one of the most significant public
Subjects were studied for a 2-week run-in period for baseline
dietary and physical activity assessment and then random-
chronic diseases such as heart disease, cancer, stroke and
ized to one of the following dietary regimens for 8 weeks:
(1) a control diet providing a 500 kcal/day deficit with
Weight loss is associated with improvement
in risk factors for cardiovascular disease (CVD) and diabetes
500e600 mg/day dietary calcium; (2) a calcium-supple-
mellitus Although much effort has been devoted to
mented diet identical to the control diet with 800 mg/day of
study the effects of macronutrients on weight control, the
calcium (as calcium carbonate); (3) a milk diet providing
role of micronutrients has not been well studied . Recent
a 500 kcal/day deficit and containing three servings (220 ml)
findings indicate that calcium metabolism and perhaps
of low fat milk (1.5%); (4) a soy milk diet providing a 500 kcal/
other components of dairy products may contribute to
day deficit and containing three servings of calcium fortified
shifting the energy balance and thus play a role in weight
soy milk. Total calcium content of the milk diet and the soy
milk diet was between 1200 and 1300 mg/day.
in 1,25-dihydroxy vitamin D which in turn stimulates
Daily caloric requirements were calculated by using the
calcium influx into adipocytes, resulting in stimulation of
HarriseBenedict equation An activity factor and meal
lipogenesis, inhibition of lipolysis and expansion of adipo-
plan based on a 500 kcal/day deficit from estimated caloric
cyte triglyceride stores. Suppressing 1,25-(OH)
requirements were given to each individual . The diets
increasing dietary calcium would be predicted to inhibit
for all groups were designed to provide comparable levels
of macronutrients as follows: 55% carbohydrate, 18%
Calcium in the form of dairy products may be more
protein and 27% fat. At baseline and at 2-week intervals,
weight, waist circumference, and hip circumference were
bioactive compounds and high concentrations of
measured and 24 h-dietary records as well as physical
branched chain amino acids in dairy products are
activity records (2 weekdays and 1 weekend day) were
taken. Body fat mass was measured at the beginning of the
To study this, we decided to compare the effects of
study and at week 8 using Bodystat bioelectric impedance
cows’ milk, calcium fortified soy milk and calcium supple-
ment on weight and body fat reduction in premenopausal
Weight was recorded in light clothing to the nearest
0.1 kg, using a digital scale. Height was measured bare footto the nearest 0.1 cm using a stadiometer. Then BMI wascalculated as weight (kg)/height2 (m). Waist and hip
circumferences were measured to the nearest 0.1 cm usinga plastic measuring tape at the smallest circumference
below the rib cage and above the umbilicus and thelargest circumference between the waist and the knees,respectively .
One hundred healthy premenopausal overweight or obesewomen ranging in age from 20 to 50 years volunteered to
participate in this randomized clinical trial while 85completed the study. There were no significant differencesbetween those who completed the study and those who did
Dietary records were analyzed using Nutritionist 4 software
not for any parameters. Inclusion criteria were as follows:
(N _V). Statistical analyses were performed using SPSS
body mass index (BMI) more than 25 kg/m2 (range 25
software version 15. One-way ANOVA was used to compare
taking no medications or supplements which might affect
the characteristics of subjects in the four groups at base-
metabolism of calcium, vitamin D or weight loss; absence of
line, and to compare the changes in weight, BMI, waist and
menopause; stable body weight (body weight change less
hip circumference, and body fat mass among the four
than 3 kg for the last 2 months); absence of coronary-artery,
groups. The paired t-test was used to estimate the effect of
diabetes, hypertension, thyroid, and kidney diseases. The
intervention in each group. A p-value <0.05 was considered
subjects were not pregnant and non-lactating with no allergy
to milk or soy milk and were not lactose intolerant. We alsomade sure that the subjects had not participated in any other
studies within the last 6 months of screening. The study wasapproved by the ethics committee of the National Nutrition
Of the 100 women meeting the general eligibility criteria,
and Food Technology Research Institute. Each potential
15 dropped out before completing the weight loss period
participant was informed of the risks and benefits associated
(5, 3, 3, and 4 persons in the control, calcium supplement,
with this study and provided written signed consent.
high milk, and soy milk groups, respectively).
Please cite this article in press as: Faghih S, et al., Comparison of the effects of cows’ milk, fortified soy milk, and calcium supplement onweight and fat loss in premenopausal overweight and obese women, Nutr Metab Cardiovasc Dis (2009), doi:10.1016/j.numecd.2009.11.013
Comparison of the effects of cows’ milk, fortified soy milk, and calcium supplement
- Baseline characteristics of subjects under study.
BMI, body mass index; MET, metabolic equivalent task units; WHR, waist-to-hip ratio.
a Mean Æ standard deviation (all such values). b One-way ANOVA.
Baseline characteristics of the subjects are shown in
in the high milk group compared to the controls (p < 0.01).
It is apparent that there were no significant
There were no significant differences between body weight
differences between the age, weight, BMI, or energy and
and BMI changes in the soy milk and calcium supplement
calcium intake of the subjects in the four groups.
groups and the controls. Weight change (% of initial) in the
Comparison of the mean of physical activity levels among
high milk group was significantly greater than in the soy milk
the four groups at baseline using one-way ANOVA showed no
group (p < 0.05) and the controls (p < 0.01).
significant difference (p Z 0.28). Also there was no signifi-cant difference between the physical activity levels ofsubjects at baseline and during the study period.
Estimates of the energy, macronutrients, calcium and
fiber intakes during the study period, from food records are
The results of this study demonstrated that a low energy
shown in which indicates there were no differences
diet (500 kcal/day deficit) for 8 weeks can lead to a signif-
in the energy, macronutrients and fiber intakes among the
icant reduction in weight, BMI, waist circumference, WHR,
four groups. Also, it is shown that the percentages of
body fat mass and percent body fat. A modest weight loss in
carbohydrate, protein and fat intake were very close to the
obese individuals (5%e10% of initial body weight) is likely to
recommended amounts of 55%, 18%, and 27%, respectively.
improve their health in the short term by reducing the
As shown in body weight, BMI, waist circum-
severity of comorbidities associated with obesity .
ference, waist-to-hip ratio (WHR), body fat mass and
Our findings also indicate that a high milk diet can lead to
percent body fat of all groups decreased significantly after
a higher reduction in weight, BMI, waist circumference, and
8 weeks of weight loss intervention (p < 0.001 for all), while
WHR. Zemel et al. showed that 18 subjects receiving 3 cups
the amount of these reductions was significantly different
of yogurt per day (1100 mg/day calcium) lost more weight
among the four groups just for waist circumference
(6.63 kg vs. 4.99 kg), body fat (4.43 kg vs. 2.75 kg), and
(p Z 0.028), WHR (p Z 0.015) and weight change (% of
abdominal circumference (3.99 cm vs. 0.58 cm) while
initial) (p Z 0.026). After adjustment for baseline values by
attenuating loss of fat-free mass (1353 g vs. 1968 g) in
using analysis of covariance, however, changes in weight
comparison with 16 subjects in a low calcium control group
and BMI were significantly different among the four groups
(400e500 mg/day) . Zemel et al. also studied the effect
(p Z 0.017 and p Z 0.019, respectively).
of an energy-restricted diet (providing either 400e500 mg/
Post Hoc tests showed that the changes in waist circum-
day from dairy products or 1200e1300 mg/day from an
ference and WHR were significantly higher in the high milk
additional 800 mg of calcium carbonate or from an addi-
(p < 0.01) and soy milk (p < 0.05) groups versus the controls.
tional three servings of dairy products) on weight and fat loss
Also reductions in weight and BMI were significantly greater
in 32 obese or overweight women. Their results indicated
- Estimates of the daily intake of energy, macronutrients, calcium and fiber of subjects during the study period.
a Mean Æ standard deviation (all such values). b One-way ANOVA.
Please cite this article in press as: Faghih S, et al., Comparison of the effects of cows’ milk, fortified soy milk, and calcium supplement onweight and fat loss in premenopausal overweight and obese women, Nutr Metab Cardiovasc Dis (2009), doi:10.1016/j.numecd.2009.11.013
that increasing dietary calcium significantly augmented
weight and fat loss secondary to caloric restriction . Afterconducting a clinical trial on 256 obese diabetic patients,
Shahar et al. reported that dairy calcium intake was asso-ciated with weight loss percentage. Among the high tertileof dairy calcium intake, the odds ratio for weight loss of >8%was 2.4, p Z 0.04, compared with the first tertile, after
controlling for non-dairy calcium intake, diet type, and the
change in energy intake from baseline. They concluded thata diet rich in dairy calcium intake enhances weight reduction
In contrast, in a 6-month trial by Harvey et al., 54 obese
adults were randomly assigned to either a high- or low-dairy
treatment along with energy restriction (500 kcal/day).
There was no significant difference in weight loss between
the groups. The authors speculated that differences inbaseline calcium intake and degree of adiposity at onsetmay have affected the response to dietary regimens Also when Bowen et al. randomly assigned 50 overweight
Australian adults to an energy-restricted diet, who derived
34% of calories from protein either largely from dairy
products (2400 mg Ca/day) or mixed sources (500 mg Ca/
day), there was no significant difference in weight loss
between the groups over 12 weeks. Considering the fact
that calcium supplementation is more effective when its
usual intake is low, the participants’ baseline calcium
intake of about 800 mg/day is a possible reason for the
Our findings showed that reductions in waist circumfer-
ence and WHR were more pronounced in the soy milk group
than the controls. Results of two randomized clinical trials on
obese or overweight women showed that soy protein-rich
food and soy isoflavones did not have any beneficial
effects on weight loss. Also data from a review article by
Cope et al. suggest that soy foods are as good as other protein
sources for promoting weight loss . So it is assumed that
higher reductions of WHR and waist circumference in the soy
milk group compared to the controls are related to the
difference in calcium intake between the two groups.
To date, numerous observational studies have identified
a strong inverse relationship between body weight and
dietary calcium and dairy product intake High dietary
calcium intake is associated with reduced 1,25-vitamin D
levels which in turn act in decreasing calcium influx into the
cell and, thus, the intracellular levels of the ion. These
modifications eventually stimulate lipolysis and inhibit
lipogenesis in the adipocytes Some recent
findings in animals and in humans suggest that there may be
greater effects on body weight from dairy-containing foods
than might be predicted from their calcium level alone
It has been suggested that milk is rich in bioactive
compounds that may also act independently from calcium
in modulating body fat accumulation and in this regard,
milk bioactive substances have been shown to act as
angiotensin converting enzyme inhibitors . Also the
branched chain amino acid content of dairy protein and
specific bioactive whey-derived peptides are candidates for
We also found that weight change (% of initial) in the high
milk group was significantly greater than that of the soy milk
group. On the other hand, Lukaszuk et al. reported that
consumption of either 720 ml of soy milk or 720 ml of skim
Please cite this article in press as: Faghih S, et al., Comparison of the effects of cows’ milk, fortified soy milk, and calcium supplement onweight and fat loss in premenopausal overweight and obese women, Nutr Metab Cardiovasc Dis (2009), doi:10.1016/j.numecd.2009.11.013
Comparison of the effects of cows’ milk, fortified soy milk, and calcium supplement
milk for 8 weeks had similar effects on body weight, and
[10] Parikh SJ, Yanovski JA. Calcium intake and adiposity. Am
abdominal circumference reductions . Considering that
Lukaszuk et al. added 6.5 g/day protein (containing leucine
[11] Shahar DR, Abel R, Elhayany A, Vardi H, Fraser D. Does dairy
but no whey) to their soy milk diet, and considering the effect
calcium intake enhance weight loss among overweightdpatients? Diabetes Care 2007;30:485
of branched chain amino acids specifically leucine
[12] Zemel MB. Role of calcium and dairy products in energy par-
on weight loss, it is assumed that weight reduction in the soy
titioning and weight management. Am J Clin Nutr 2004;79(5):
milk group was augmented by the added protein.
The fact that calcium fortified soy milk did not exert
[13] Thompson WG, Holdman NR, Jancow DJ, Slezak JM, Morris KL,
body weight changes as much as low fat milk, might be due
Zemel MB. Effect of energy-reduced diets high in dairy prod-
to the presence of branched chain amino acids and bioac-
ucts and fiber on weight loss in obese adults. Obes Res 2005;
tive compounds (such as angiotensin converting enzyme
inhibitors) in cows’ milk which merits future studies.
[14] Shapses SA, Heshka S, Heymsfield SB. Effect of calcium
In conclusion, our results showed that consumption of
supplementation on weight and fat loss in women. J Clin
low-fat milk enhanced the beneficial effect of an energy-
[15] Barr SI. Increased dairy product or calcium intake: is body weight
restricted diet on central and general obesity and therefore
or composition affected in humans? J Nutr 2003;133:245S
a diet rich in dairy calcium could be tried in obese persons.
[16] Barba G, Russo P. Dairy foods, dietary calcium and obesity:
a short review of the evidence. Nutr Metab Cardiovasc Dis
[17] Zemel MB. The role of dairy foods in weight management.
[18] Zemel MB, Shi H, Greer B, Dirienzo D, Zemel PC. Regulation of
adiposity by dietary calcium. FASEB J 2000;14:1132e8.
[19] Teegarden D, Zemel M. Dairy product components and weight
regulation: symposium overview. J Nutr 2003;133:243Se4S.
[20] Major GC, Alarie F, Dore J, Phouttama S, Trembly A. Supple-
This study was funded by the National Nutrition and Food
mentation with calcium þ vitamin D enhances the beneficialeffect o weight loss on plasma lipid and lipoprotein concen-
Technology Research Institute. We thank Iran Daru
Company for providing us with calcium carbonate capsules.
[21] Hammond KA. Dietary and clinical assessment. In: Mahan LK,
Escott-Stump S, editors. Krause0s food and nutrition therapy.
12th ed. USA: Saunders; 2008. p. 372.
[22] Hammond KA. Dietary and clinical assessment. In: Mahan LK,
[1] Sakhaee Kh, Maalouf NM. Dietary calcium, obesity and
Escott-stump S, editors. Krause0s food nutrition and diet
therapy. 10th ed. USA: Saunders; 2000. p. 372.
dthe end of the road? J Clin Endocrinol Metab
[23] Gee M, Mahan LK, Escott-Stomp S. Weight management. In:
[2] McLaughlin T, Carter S, Lamendola C, Abbasi F, Yee G, Schaaf P,
Mahan LK, Escott-Stump S, editors. Krause0s food and nutrition
et al. Effects of moderate variations in macronutrient composition
therapy. 12th ed. USA: Saunders; 2008. p. 543.
on weight loss and reduction in cardiovascular disease risk in
[24] Zemel MB, Richards J, Milstead A, Gebhardt L, Silva E. Dairy
obese, insulin-resistant adults. Am J Clin Nutr 2006;84(4):813
augmentation of total and central fat loss in obese subjects.
[3] Bougoulia M, Triantos A, Koliakos G. Effect of weight loss with
or without orlistat treatment on adipocytokines, inflamma-
[25] Harvey J, Gold BC, Lauber R, Starinski A. The impact of
tion, and oxidative markers in obese women. Hormones 2006;
calcium and dairy product consumption on weight loss. Obes
[4] Barbato KB, Martins RC, Rodrigues ML, Braga JU, Francischetti EA,
[26] Bowen J, Noakes M, Clifton PM. A high dairy protein high-
Genelhu V. Effects of greater-than-5% weight reduction on
calcium diet minimizes bone turn over in over weigh adults
hemodynamic, metabolic and neuroendocrine profiles of grade I
during weight loss. J Nutr 2004;134:568e73.
obese subjects. Arq Bras Cardiol 2006;87(1):12
[27] St-onge MP, Claps N, Wolper C, Heymsfield SB. Supplementa-
[5] Teegarden D. Calcium intake and reduction in weight or fat
tion with soy-protein-rich foods does not enhance weight loss.
[6] Kumada M, Kihara Sh, Sumitsuji S, Kawamoto T, Matsumoto S,
[28] Weikert MO, Reimann M, Otto B, Hall WL, Vafeiadou K,
Ouchi N, et al. Association of hypoadiponectinemia with coro-
Hallund J, et al. Soy isoflavones increase preprandial peptide YY
nary artery disease in men. Arterioscler Thromb Vasc Biol 2003;
(PYY), but have no effect on grelin and body weight in healthy
postmenopausal women. J Negat Results Biomed 2006;5:11e6.
[7] Weyer C, Funahashi T, Tanaka S, Hotta K, Matsuzawa Y,
[29] Cope MB, Erdman JW, Allison DB. The potential role of soy
Pratley RE, et al. Hypoadiponectinemia in obesity and type 2
foods in weight and adiposity reduction: an evidence-based
diabetes: close association with insulin resistance and hyper-
insulinemia. J Clin Endocrinol Metab 2001;86(5):1930
[30] Huth PJ, Dirienzo DB, Miller GD. Major scientific advances with
[8] Andrew P, Selwyn MD. Weight reduction and cardiovascular
dairy foods in nutrition and health. J Dairy Sci 2006;89:1207e21.
and metabolic disease prevention: clinical trial update. J Am
[31] Lukazuk JM, Luebbers P, Gordon BA. Preliminary study: soy
milk as effective as skim milk in promoting weight loss. J Am
[9] Zemel MB, Thompson W, Milstead A, Morris K, Campbell P.
Calcium and dairy acceleration of weight and fat loss during
[32] Layman DK. The role of leucine in weight loss diets and
energy restriction in obese adults. Obes Res 2004;12:582
glucose homeostasis. J Nutr 2003;133:261se7s.
Please cite this article in press as: Faghih S, et al., Comparison of the effects of cows’ milk, fortified soy milk, and calcium supplement onweight and fat loss in premenopausal overweight and obese women, Nutr Metab Cardiovasc Dis (2009), doi:10.1016/j.numecd.2009.11.013
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Boletín de divulgación científica para la educación de la salud¿Qué es la menopausia?La menopausia no es una enfermedad sino una transición natural en la vida de la mujer que resulta de la dis‐minución de la producción ovárica de hormonas sexuales –estrógenos, progesterona y testosterona, y estos cambios hormonales tienen diversas consecuencias para su salud (1). La menopausia