Phase 4
N=79
Exercise and Phytoestrogens: Effect on Factors Predisposing to Cardiovascular Disease(CVD) in Postmenopausal Women
Overweight
Bottom Line
View on ClinicalTrials.gov: NCT01048606 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Body Composition: Dual-energy X-ray Absorptiometry Method — 44.5; 48.8; 43.8; 46.6 percent of total fat mass
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo + exercise (Behavioral); Phytoestrogens without exercise (Dietary_supplement); Phytoestrogens + exercise (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Université de Sherbrooke
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Composition: Dual-energy X-ray Absorptiometry Method |
— | — |
| PRIMARY Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State) |
— | — |
| PRIMARY Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis). |
— | — |
| PRIMARY Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo. |
— | — |
| PRIMARY Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale. |
— | — |
| PRIMARY Plasma Fibrinogen Levels Measured With Luminescence. |
— | — |
| PRIMARY Body Composition: Dual-energy X-ray Absorptiometry Method |
— | — |
| PRIMARY Body Composition: Dual-energy X-ray Absorptiometry Method |
— | — |
| PRIMARY Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State) |
— | — |
| PRIMARY Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State) |
— | — |
| PRIMARY Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis). |
— | — |
| PRIMARY Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis). |
— | — |
| PRIMARY Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo. |
— | — |
| PRIMARY Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo. |
— | — |
| PRIMARY Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA) |
— | — |
| PRIMARY Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA) |
— | — |
| PRIMARY Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA) |
— | — |
| PRIMARY Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale |
— | — |
| PRIMARY Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale |
— | — |
| PRIMARY Plasma Fibrinogen Levels Measured With Luminescence. |
— | — |
| PRIMARY Plasma Fibrinogen Levels Measured With Luminescence. |
— | — |
| SECONDARY Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval) |
— | — |
| SECONDARY Physical Activity Level: Physical Activity Scale for the Elderly (PASE) |
— | — |
| SECONDARY Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method |
— | — |
| SECONDARY Metabolic Rate at Rest: During 30 Minutes With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA) After a 12-hour Fast, in the Early Morning. |
— | — |
| SECONDARY Maximal Oxygen Uptake Measured Using a Continuous, Incremental Protocol (Balke Modified Protocol) on a Treadmill With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA). |
— | — |
| SECONDARY Physical Capacity: 3 Tests From the Senior Fitness Test (Chair Stand Test, Chair Sit-and-Reach Test, Back Scratch Test) + Handgrip Strength Test (Lafayette Hand Dynamometer, Indiana) |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01048606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.