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

NCT ID: NCT00204425

Last Updated: 2011-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2010-04-30

Brief 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.

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.

Conditions

Osteoporosis; Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: QUADRUPLE

Study Groups

1

exercise/soy isoflavone

Group Type: EXPERIMENTAL

exercise/soy isoflavone

Intervention Type: DIETARY_SUPPLEMENT

Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

2

exercise/isoflavone placebo

Group Type: EXPERIMENTAL

exercise/soy isoflavone

Intervention Type: DIETARY_SUPPLEMENT

Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

3

exercise placebo/soy isoflavone

Group Type: EXPERIMENTAL

exercise/soy isoflavone

Intervention Type: DIETARY_SUPPLEMENT

Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

4

exercise placebo/isoflavone placebo

Group Type: PLACEBO_COMPARATOR

exercise/soy isoflavone

Intervention Type: DIETARY_SUPPLEMENT

Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

Interventions

exercise/soy isoflavone

Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Archer Daniels Midland

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Phil Chilibeck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip D Chilibeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

H J Biem, M.D.

Role: STUDY_DIRECTOR

University of Saskatchewan

Allison Case, M.D.

Role: STUDY_DIRECTOR

University of Saskatchewan

Olufemi Olantunbosun, M.D.

Role: STUDY_DIRECTOR

University of Saskatchewan

Roger Pierson, PhD

Role: STUDY_DIRECTOR

University of Saskatchewan

Susan Whiting, PhD

Role: STUDY_DIRECTOR

University of Saskatchewan

Punam Pahwa, PhD

Role: STUDY_DIRECTOR

University of Saskatchewan

Locations

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

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.

Reference Type: BACKGROUND

PMID: 15001805 (View on PubMed)

Other Identifiers

124322 FRN68095

Identifier Type: -

Identifier Source: secondary_id

Bio 03-1077

Identifier Type: -

Identifier Source: org_study_id