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Clinical Trials/NCT01048606
NCT01048606
Completed
Phase 4

Exercise and Phytoestrogens: a Synergistic Effect on Factors Predisposing to CVD in Postmenopausal Women

Université de Sherbrooke1 site in 1 country45 target enrollmentJanuary 2009
ConditionsOverweight

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Overweight
Sponsor
Université de Sherbrooke
Enrollment
45
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
November 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Isabelle J Dionne

PhD

Université de Sherbrooke

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Body Composition: Dual-energy X-ray Absorptiometry Method

Time Frame: 12 months

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

Plasma Fibrinogen Levels Measured With Luminescence.

Time Frame: 12 months

Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).

Time Frame: 12 months

Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale.

Time Frame: Baseline

Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale

Time Frame: 12 months

Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)

Time Frame: 12 months

Secondary Outcomes

  • Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method(0, 6 and 12 months)
  • 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.(0, 6 and 12 months)
  • 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).(0 and 12 months)
  • 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)(0, 6 and 12 months)
  • Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval)(0, 6 and 12 months)
  • Physical Activity Level: Physical Activity Scale for the Elderly (PASE)(0, 6 and 12 months)

Study Sites (1)

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