ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise and Phytoestrogens: Effect on Factors Predisposing to Cardiovascular Disease(CVD) in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01048606
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Isabelle J Dionne, Université de Sherbrooke

January 12, 2010
January 13, 2010
December 18, 2013
February 12, 2014
February 12, 2014
January 2009
November 2012   (Final data collection date for primary outcome measure)
  • Body Composition: Dual-energy X-ray Absorptiometry Method [ Time Frame: Baseline ]
  • 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 ]
  • Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis). [ Time Frame: Baseline ]
  • 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 ]
  • Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale. [ Time Frame: Baseline ]
  • Plasma Fibrinogen Levels Measured With Luminescence. [ Time Frame: Baseline ]
  • Body Composition: Dual-energy X-ray Absorptiometry Method [ Time Frame: 6 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: 6 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 ]
  • Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis). [ Time Frame: 6 months ]
  • Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis). [ Time Frame: 12 months ]
  • 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 ]
  • 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 ]
  • Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA) [ Time Frame: Baseline ]
  • Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA) [ Time Frame: 6 months ]
  • Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA) [ Time Frame: 12 months ]
  • Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale [ Time Frame: 6 months ]
  • Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale [ Time Frame: 12 months ]
  • Plasma Fibrinogen Levels Measured With Luminescence. [ Time Frame: 6 months ]
  • Plasma Fibrinogen Levels Measured With Luminescence. [ Time Frame: 12 months ]
  • Body Composition: Dual-energy X-ray Absorptiometry Method [ Time Frame: 0, 6 and 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: 0, 6 and 12 months ]
  • Sex-hormone levels: estradiol, estrone, progesterone, testosterone and SHBG will be obtained by Enzyme Immuno Assay (EIA). [ Time Frame: 0, 6 and 12 months ]
  • Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis). [ Time Frame: 0, 6 and 12 months ]
  • 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: 0, 6 and 12 months ]
  • Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale. [ Time Frame: 0, 6 and 12 months ]
  • Plasma Fibrinogen Levels Measured With Luminescence. [ Time Frame: 0, 6 and 12 months ]
Complete list of historical versions of study NCT01048606 on ClinicalTrials.gov Archive Site
  • Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval) [ Time Frame: 0, 6 and 12 months ]
  • Physical Activity Level: Physical Activity Scale for the Elderly (PASE) [ Time Frame: 0, 6 and 12 months ]
  • Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 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) [ Time Frame: 0, 6 and 12 months ]
  • Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval) [ Time Frame: 0, 6 and 12 months ]
  • Physical Activity Level: Physical Activity Scale for the Elderly (PASE) [ Time Frame: 0, 6 and 12 months ]
  • Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method [ Time Frame: 0, 6 and 12 months ]
  • Metbolic 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 ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Exercise and Phytoestrogens: Effect on Factors Predisposing to Cardiovascular Disease(CVD) in Postmenopausal Women
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Overweight
  • 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.

  • 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.

  • 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.

  • Active Comparator: Placeco + exercise
    Placebo (no phytoestrogen): 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 (three 1h-sessions/week)
    Intervention: Behavioral: Placebo + exercise
  • Active Comparator: Phytoestrogens without exercise
    Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)
    Intervention: Dietary Supplement: Phytoestrogens without exercise
  • Experimental: Phytoestrogens + exercise
    Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)
    Intervention: Other: Phytoestrogens + exercise
  • No Intervention: 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) No exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
120
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
50 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01048606
IDionne_phyto_2008-2011
No
Not Provided
Not Provided
Isabelle J Dionne, Université de Sherbrooke
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Isabelle J Dionne, Ph.D. Université de Sherbrooke
Université de Sherbrooke
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP