Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise and Phytoestrogens: a Synergistic Effect on Factors Predisposing to CVD in Postmenopausal Women
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* aged ≥ 30 years and not institutionalized
* body mass index 25 to 50 kg/m2
* urinary incontinence symptoms for \> 3 months by self-report and record \> 10 incontinent episodes per week on a 7-day urinary diary
* able to complete a behavioral run-in consisting of self-monitoring of food and activity
* report having a primary health care provider
* able to understand and sign informed consent and complete baseline questionnaires
* agree to not initiate new treatment for incontinence or weight reduction, including behavioral, pharmacological or surgical therapies, for the duration of the study

Exclusion Criteria:

* current use, or use within the previous month of medical therapy for incontinence
* currently pregnant or gave birth in the previous 6 months
* current urinary tract infection (dipstick urinalysis positive for leukocyte esterase, nitrites or blood) or report having \> 4 urinary tract infections in the preceding year
* incontinence of neurologic or functional origin (by history)
* self-report of prior anti-incontinence or urethral surgery, pelvic cancer or pelvic irradiation
* self-report of significant medical conditions of the genitourinary tract (genitourinary fistula, interstitial cystitis, symptomatic pelvic organ prolapse)
* report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity, including type 2 diabetes requiring medical therapy that may cause hypoglycemia, chronic steroid use or uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \> 100 mm Hg); women with a history of coronary heart disease may participate with written approval from their primary care physician
* currently engaged in an active weight loss program and/or experienced a 10% or greater weight reduction in the past 3 months
* report being unable to walk 2 blocks (1/4 mile) without stopping
* report conditions that, in the judgment of the Clinical Center Principal Investigator, render potential participants unlikely to follow the protocol for 18 months, including illness likely to be terminal within 2 years, plans to move, substance abuse or other significant psychiatric problems, or dementia
* participating in another research study that involves investigational drugs or can potentially confound the results of PRIDE
B: Postmenopausal women aged 45 to 75 years who are overweight or obese (body mass index of 25 to 40 kg/m2) and have normal or mildly elevated BP.
C: Postmenopausal women ages 50 to 79.
D: Inclusion Criteria:

* 50-70 years
* francophone or understanding French
* body mass index \> 27kg/m²
* without physical disability
* without medical treatment influencing metabolism
* non smoker
* light drinker (\<15 g ethanol/day = 1 alcoholic beverage)
* weight stable (\< 2 kg) for 6 mo
* no participation in a supervised exercise program for 6 mo
* without HRT for at least 3 yrs
* and without menses for at least 12 mo

Exclusion Criteria:

* soy allergy
* known hepatic diseases
* asthma
* family history of accident cerebro-vascular
* personal history of a feminine cancer

Answer: D