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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014