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

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ClinicalTrials.gov Identifier: NCT00204425
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 13, 2011
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis
Study Start Date : December 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Lumbar spine bone mineral density at 12 and 24 months [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Bone mineral density of the proximal femur at 12 and 24 months. [ Time Frame: 2 years ]
  2. Bone mineral density of the whole body at 12 and 24 months. [ Time Frame: 2 years ]
  3. Bone quality of the radius and tibia (ultrasound) at 12 and 24 months. [ Time Frame: 2 years ]
  4. Geometry of the proximal femur at at 12 and 24 months. [ Time Frame: 2 years ]
  5. Lean tissue mass at 12 and 24 months. [ Time Frame: 2 years ]
  6. Fat mass at 12 and 24 months. [ Time Frame: 2 years ]
  7. Body mass index at 12 and 24 months. [ Time Frame: 2 years ]
  8. Waist girth at 12 and 24 months. [ Time Frame: 2 years ]
  9. Blood lipids at 12 and 24 months. [ Time Frame: 2 years ]
  10. Muscular strength at 12 and 24 months. [ Time Frame: 2 years ]
  11. Self-paced walking ability at 12 and 24 months. [ Time Frame: 2 years ]
  12. Balance at 12 and 24 months. [ Time Frame: 2 years ]
  13. Flexibility at 12 and 24 months. [ Time Frame: 2 years ]
  14. Breast density at 24 months [ Time Frame: 2 years ]
  15. Endometrial thickness at 24 months. [ Time Frame: 2 years ]
  16. Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months. [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

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

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