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

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:

MedlinePlus related topics: Bone Density Dietary Supplements Exercise and Physical Fitness Menopause Minerals Osteoporosis

U.S. FDA Resources

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:

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. Review.

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 May 16, 2013