Effect of Exercise Training and Soy-based Nutritional Supplementation on Prevention of Osteoporosis

Osteoporosis Clinical Trial

Official title: Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

• NCT number: NCT00204425
• Study type: Interventional
• Source: University of Saskatchewan
• Status: Completed
• Phase: Phase 3
• Start date: December 2004
• Completion date: April 2010