Overweight Clinical Trial
Official title:
Exercise and Phytoestrogens: a Synergistic Effect on Factors Predisposing to CVD in Postmenopausal Women
Menopause is characterized by a decrease of estrogen and progesterone levels and is
associated with various changes in body composition, including an accumulation of total fat
mass, a relocation of adiposity to the abdomen, deterioration of plasma lipid profile,
increased risk of type 2 diabetes, and increased oxidative stress. Taken together, these
changes increase the risk of developing cardiovascular disease (CVD).
Physical activity and hormone-replacement therapy (HRT) have been shown to act in synergy to
improve total fat mass in postmenopausal (PM) women. Because the progesterone component of
HRT has been associated with an increased CVD risk in older women with a family history of
CVD, the use of HRT has become controversial. As a result, a large decrease of the use of
HRT in the community has been observed and postmenopausal women (PM) have developed interest
in alternative therapies. Among the possibilities, phytoestrogens have shown beneficial
effects on menopausal symptoms and plasma lipids. Phytoestrogens are structurally and
functionally similar to estradiol (the major estrogen in humans) but found only in plants
such as soybean isoflavones. They do not exert any effect on breast cancer or/and
endometrial tissue.
AIMS To examine the effects of phytoestrogens, exercise and the combination of both on lean
body mass, total fat mass, visceral fat, blood lipid profile, oxidative stress markers,
antioxidant system, glucose metabolism, and sex-hormone levels in obese PM women.
HYPOTHESES Women undergoing a combination of phytoestrogen treatment and an exercise program
will display a greater increase in lean body mass, decrease in total and visceral fat mass,
improvements in blood lipid profile, decrease in oxidative stress markers, increase in
antioxidant system, improvement in glucose metabolism, and increase in sex-hormone levels
than those submitted to any or one of the treatments.
A total of 120 women will be recruited. There will be 4 groups (30 women/group) undergoing
exercise or not and supplemented with phytoestrogens or a placebo. The intervention is
planned to last 12 mo. Key variables will be measured at baseline, and after 6 and 12 mo of
intervention.
Three weekly 1h-sessions of exercise will be held on 3 non-consecutive days. The
phytoestrogen supplements will consist of 70 mg/d of soy isoflavones taken as 4 caps/day.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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