Osteoporosis Clinical Trial
Official title:
Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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