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

U

University of Saskatchewan

Status and phase

Completed
Phase 3

Conditions

Osteopenia
Osteoporosis

Treatments

Dietary Supplement: exercise/soy isoflavone

Study type

Interventional

Funder types

Other

Identifiers

NCT00204425
Bio 03-1077
124322 FRN68095

Details and patient eligibility

About

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.

Full 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.

Enrollment

351 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

351 participants in 4 patient groups, including a placebo group

1
Experimental group
Description:
exercise/soy isoflavone
Treatment:
Dietary Supplement: exercise/soy isoflavone
2
Experimental group
Description:
exercise/isoflavone placebo
Treatment:
Dietary Supplement: exercise/soy isoflavone
3
Experimental group
Description:
exercise placebo/soy isoflavone
Treatment:
Dietary Supplement: exercise/soy isoflavone
4
Placebo Comparator group
Description:
exercise placebo/isoflavone placebo
Treatment:
Dietary Supplement: exercise/soy isoflavone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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