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Completed

NCT Number: NCT00204425

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise/soy isoflavone

Dietary Supplement

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

Other names: Archer Daniels Midland

Primary outcomes

  1. Lumbar spine bone mineral density at 12 and 24 months

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis

Important dates

Study start
2004
Primary completion
2007
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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