Exercise and Phytoestrogens: Effect on Factors Predisposing to Cardiovascular Disease(CVD) in Postmenopausal Women
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopause Overweight |
Behavioral: Placebo + exercise Dietary Supplement: Phytoestrogens without exercise Other: Phytoestrogens + exercise Other: Placebo without exercise |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Exercise and Phytoestrogens: a Synergistic Effect on Factors Predisposing to CVD in Postmenopausal Women |
- Body composition: dual-energy x-ray absorptiometry method [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- 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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Glucose metabolism: 2h-75g oral glucose tolerance test (OGTT) + plasma insulin and glucose concentrations (blood sample analysis). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Quality of life: assessed with questionnaires (SF-36 (general health perceptions), Kupperman Index, Perceived Stress Scale. [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Plasma fibrinogen levels measured with luminescence. [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Body composition: dual-energy x-ray absorptiometry method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Body composition: dual-energy x-ray absorptiometry method [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Glucose metabolism: 2h-75g oral glucose tolerance test (OGTT) + plasma insulin and glucose concentrations (blood sample analysis). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Glucose metabolism: 2h-75g oral glucose tolerance test (OGTT) + plasma insulin and glucose concentrations (blood sample analysis). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Sex-hormone levels. Estradiol, estrone, progesterone, testosterone and SHBG will be obtained by Enzyme Immuno Assay (EIA) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Sex-hormone levels. Estradiol, estrone, progesterone, testosterone and SHBG will be obtained by Enzyme Immuno Assay (EIA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Sex-hormone levels. Estradiol, estrone, progesterone, testosterone and SHBG will be obtained by Enzyme Immuno Assay (EIA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Dietary intakes: 3-days food record. Dietary analyses will be completed using the Nutifiq software (Université Laval) [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Physical activity level: Physical Activity Scale for the Elderly (PASE) [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Plasma isoflavones (diadzein) - a marker of phytoestrogen compliance - will be measured by the ELISA method [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
- 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). [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
- 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) [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Placeco + exercise
Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)
|
Behavioral: Placebo + exercise
Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day) Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist. |
|
Active Comparator: Phytoestrogens without exercise
Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)
|
Dietary Supplement: Phytoestrogens without exercise
Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy. Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions. |
|
Active Comparator: Phytoestrogens + exercise
Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)
|
Other: Phytoestrogens + exercise
Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy. Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist. |
|
No Intervention: Placebo without exercise
Placebo (no phytoestrogens) Without exercise (no structured exercise session)
|
Other: Placebo without exercise
Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day). Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions. |
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Isabelle J. Dionne, Ph.D. | 819-780-2220 ext 45671 | Isabelle.Dionne@USherbrooke.ca |
| Contact: Karine Perreault, B.Sc. | 819-780-2220 ext 45274 | Karine.Perreault@USherbrooke.ca |
| Canada, Quebec | |
| Centre de recherche sur le vieillissement du CSSS-IUGS | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 4C4 | |
| Contact: Isabelle J Dionne, Ph.D. 819-780-2220 ext 45671 Isabelle.Dionne@USherbrooke.ca | |
| Contact: Karine Perreault, B.Sc. 819-780-2220 ext 45274 Karine.Perreault@USherbrooke.ca | |
| Principal Investigator: | Isabelle J Dionne, Ph.D. | Universitaire de Sherbrooke |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Professor Isabelle J. Dionne, Université de Sherbrooke |
| ClinicalTrials.gov Identifier: | NCT01048606 History of Changes |
| Other Study ID Numbers: | IDionne_phyto_2008-2011 |
| Study First Received: | January 12, 2010 |
| Last Updated: | August 9, 2011 |
| Health Authority: | Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee |
Keywords provided by Universitaire de Sherbrooke:
|
Postmenopause Overweight Women Phytoestrogens |
Exercise Cardiovascular Diseases Risk Factors Aging |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Overweight Body Weight Signs and Symptoms Phytoestrogens Estrogens, Non-Steroidal |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013