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

Overview

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.

Full Title of Study: “Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2007

Detailed 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.

Interventions

  • Dietary Supplement: exercise/soy isoflavone
    • Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

Arms, Groups and Cohorts

  • Experimental: 1
    • exercise/soy isoflavone
  • Experimental: 2
    • exercise/isoflavone placebo
  • Experimental: 3
    • exercise placebo/soy isoflavone
  • Placebo Comparator: 4
    • exercise placebo/isoflavone placebo

Clinical Trial Outcome Measures

Primary Measures

  • Lumbar spine bone mineral density at 12 and 24 months
    • Time Frame: 2 years

Secondary Measures

  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Post-menopausal women Exclusion Criteria:

  • Diagnosed osteoporotic – Previous fragility fractures – Previous breast cancer – Previous endometrial cancer – Taken bisphosphonates in past 12 months – Taken hormone replacement therapy in past 12 months – Taken selective estrogen receptor modulators in past 12 months – Taken parathyroid hormone in past 12 months – Taken calcitonin in past 12 months – Currently taking corticosteroids – Currently taking a thiazide diuretic – Crohn's Disease – Cushing Disease – Allergy to soy – Severe osteoarthritis – Currently participating in vigorous exercise

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Saskatchewan
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Phil Chilibeck, Professor – University of Saskatchewan
  • Overall Official(s)
    • Philip D Chilibeck, PhD, Principal Investigator, University of Saskatchewan
    • H J Biem, M.D., Study Director, University of Saskatchewan
    • Allison Case, M.D., Study Director, University of Saskatchewan
    • Olufemi Olantunbosun, M.D., Study Director, University of Saskatchewan
    • Roger Pierson, PhD, Study Director, University of Saskatchewan
    • Susan Whiting, PhD, Study Director, University of Saskatchewan
    • Punam Pahwa, PhD, Study Director, University of Saskatchewan

References

Chilibeck PD. Exercise and estrogen or estrogen alternatives (phytoestrogens, bisphosphonates)for preservation of bone mineral in postmenopausal women. Can J Appl Physiol. 2004 Feb;29(1):59-75. doi: 10.1139/h04-006.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.