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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00204425
First received: September 12, 2005
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Osteopenia
Dietary Supplement: exercise/soy isoflavone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Lumbar spine bone mineral density at 12 and 24 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density of the proximal femur at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Bone mineral density of the whole body at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Bone quality of the radius and tibia (ultrasound) at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Geometry of the proximal femur at at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Lean tissue mass at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Fat mass at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Body mass index at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Waist girth at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Blood lipids at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Muscular strength at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Self-paced walking ability at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Balance at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Flexibility at 12 and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Breast density at 24 months [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Endometrial thickness at 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: December 2004
Study Completion Date: April 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
exercise/soy isoflavone
Dietary Supplement: exercise/soy isoflavone
Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
Other Name: Archer Daniels Midland
Experimental: 2
exercise/isoflavone placebo
Dietary Supplement: exercise/soy isoflavone
Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
Other Name: Archer Daniels Midland
Experimental: 3
exercise placebo/soy isoflavone
Dietary Supplement: exercise/soy isoflavone
Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
Other Name: Archer Daniels Midland
Placebo Comparator: 4
exercise placebo/isoflavone placebo
Dietary Supplement: exercise/soy isoflavone
Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
Other Name: Archer Daniels Midland

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204425

Locations
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5B2
Sponsors and Collaborators
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Philip D Chilibeck, PhD University of Saskatchewan
Study Director: H J Biem, M.D. University of Saskatchewan
Study Director: Allison Case, M.D. University of Saskatchewan
Study Director: Olufemi Olantunbosun, M.D. University of Saskatchewan
Study Director: Roger Pierson, PhD University of Saskatchewan
Study Director: Susan Whiting, PhD University of Saskatchewan
Study Director: Punam Pahwa, PhD University of Saskatchewan
  More Information

Publications:
Responsible Party: Phil Chilibeck, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00204425     History of Changes
Other Study ID Numbers: Bio 03-1077, 124322 FRN68095
Study First Received: September 12, 2005
Last Updated: September 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Saskatchewan:
Osteoporosis
Bone
Exercise
Soy
Isoflavone
Phytoestrogen
Menopause
Lipids

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014