Trial Outcomes & Findings for Exercise and Phytoestrogens: Effect on Factors Predisposing to Cardiovascular Disease(CVD) in Postmenopausal Women (NCT NCT01048606)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

Baseline

Results posted on

2014-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Placeco + Exercise Placebo (no phytoestrogen) Exercise (three 1h-sessions/week) 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.	Phytoestrogens Without Exercise Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session) 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.	Phytoestrogens + Exercise Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week) 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.	Placebo Without Exercise Placebo (no phytoestrogens) Without exercise (no structured exercise session) 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).
Overall Study STARTED	28	15	26	10
Overall Study COMPLETED	16	8	16	5
Overall Study NOT COMPLETED	12	7	10	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placeco + Exercise n=28 Participants Placebo (no phytoestrogen) Exercise (three 1h-sessions/week) 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.	Phytoestrogens Without Exercise n=15 Participants Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session) 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.	Phytoestrogens + Exercise n=26 Participants Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week) 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.	Placebo Without Exercise n=10 Participants Placebo (no phytoestrogens) Without exercise (no structured exercise session) 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).	Total n=79 Participants Total of all reporting groups
Age, Continuous	59.5 years STANDARD_DEVIATION 5.7 • n=5 Participants	58.4 years STANDARD_DEVIATION 4.3 • n=7 Participants	60.5 years STANDARD_DEVIATION 3.8 • n=5 Participants	61.7 years STANDARD_DEVIATION 3.9 • n=4 Participants	60.4 years STANDARD_DEVIATION 4.8 • n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants	10 Participants n=4 Participants	79 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Canada	28 participants n=5 Participants	15 participants n=7 Participants	26 participants n=5 Participants	10 participants n=4 Participants	79 participants n=21 Participants
Body Mass Index	29.8 kg/m2 STANDARD_DEVIATION 4.7 • n=5 Participants	33.8 kg/m2 STANDARD_DEVIATION 5.8 • n=7 Participants	30.3 kg/m2 STANDARD_DEVIATION 5.3 • n=5 Participants	31.1 kg/m2 STANDARD_DEVIATION 2.9 • n=4 Participants	30.9 kg/m2 STANDARD_DEVIATION 5.1 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Placeco + Exercise n=28 Participants Placebo (no phytoestrogen) Exercise (three 1h-sessions/week) 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.	Phytoestrogens Without Exercise n=15 Participants Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session) 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.	Phytoestrogens + Exercise n=26 Participants Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week) 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.	Placebo Without Exercise n=10 Participants Placebo (no phytoestrogens) Without exercise (no structured exercise session) 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).
Body Composition: Dual-energy X-ray Absorptiometry Method	44.5 percent of total fat mass Standard Deviation 5.5	48.8 percent of total fat mass Standard Deviation 5.0	43.8 percent of total fat mass Standard Deviation 4.8	46.6 percent of total fat mass Standard Deviation 2.8

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 6 and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 6 and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 6 and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 6 and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 and 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 6 and 12 months

Outcome measures

Outcome data not reported

Adverse Events

Placeco + Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phytoestrogens Without Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phytoestrogens + Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Without Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Isabelle Dionne, Ph.D., vice-dean to research and graduate studies

Université de Sherbrooke

Phone: 1-819-821-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place