The purpose of the study is to determine the effectiveness of combining exercise training (i.e. weight lifting and walking) and dietary supplementation with a soy-based nutritional supplement for increasing bone mineral density. We hypothesize that the exercise training and soy-based supplement will be additive for increasing bone mineral density.
Exercise training is effective for increasing bone mineral density and preventing osteoporosis, but the effects are small. When estrogen replacement is given to post-menopausal women the effectiveness of exercise training for improving bone mineral density is increased. Currently many women are concerned about the risks of taking hormone-replacement therapy and are seeking alternative therapies. The purpose of our study therefore is to use an estrogen-like dietary supplement derived from soy called a phytoestrogen (soy isoflavone) combined with exercise training for improving bone mineral density. Comparisons: Four groups are being compared: 1) Exercise training (i.e. weight lifting 2 times per week and walking 4 times per week) plus soy isoflavone (90 mg aglycone equivalents per day); 2) Exercise training plus placebo; 3) Exercise placebo (flexibility exercises four times per week) plus soy isoflavone; 4) Exercise placebo plus placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
351
Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Lumbar spine bone mineral density at 12 and 24 months
Time frame: 2 years
Bone mineral density of the proximal femur at 12 and 24 months.
Time frame: 2 years
Bone mineral density of the whole body at 12 and 24 months.
Time frame: 2 years
Bone quality of the radius and tibia (ultrasound) at 12 and 24 months.
Time frame: 2 years
Geometry of the proximal femur at at 12 and 24 months.
Time frame: 2 years
Lean tissue mass at 12 and 24 months.
Time frame: 2 years
Fat mass at 12 and 24 months.
Time frame: 2 years
Body mass index at 12 and 24 months.
Time frame: 2 years
Waist girth at 12 and 24 months.
Time frame: 2 years
Blood lipids at 12 and 24 months.
Time frame: 2 years
Muscular strength at 12 and 24 months.
Time frame: 2 years
Self-paced walking ability at 12 and 24 months.
Time frame: 2 years
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Balance at 12 and 24 months.
Time frame: 2 years
Flexibility at 12 and 24 months.
Time frame: 2 years
Breast density at 24 months
Time frame: 2 years
Endometrial thickness at 24 months.
Time frame: 2 years
Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months.
Time frame: 2 years