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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Dietary Supplement: exercise/soy isoflavone


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>exercise/soy isoflavone | Dietary Supplement: exercise/soy isoflavone<br>* Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo<br>* Other names: Archer Daniels Midland;|
| Experimental: 2<br>exercise/isoflavone placebo | Dietary Supplement: exercise/soy isoflavone<br>* Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo<br>* Other names: Archer Daniels Midland;|
| Experimental: 3<br>exercise placebo/soy isoflavone | Dietary Supplement: exercise/soy isoflavone<br>* Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo<br>* Other names: Archer Daniels Midland;|
| Placebo Comparator: 4<br>exercise placebo/isoflavone placebo | Dietary Supplement: exercise/soy isoflavone<br>* Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo<br>* Other names: Archer Daniels Midland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar spine bone mineral density at 12 and 24 months |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of the proximal femur at 12 and 24 months. |  | 2 years | 
| Bone mineral density of the whole body at 12 and 24 months. |  | 2 years | 
| Bone quality of the radius and tibia (ultrasound) at 12 and 24 months. |  | 2 years | 
| Geometry of the proximal femur at at 12 and 24 months. |  | 2 years | 
| Lean tissue mass at 12 and 24 months. |  | 2 years | 
| Fat mass at 12 and 24 months. |  | 2 years | 
| Body mass index at 12 and 24 months. |  | 2 years | 
| Waist girth at 12 and 24 months. |  | 2 years | 
| Blood lipids at 12 and 24 months. |  | 2 years | 
| Muscular strength at 12 and 24 months. |  | 2 years | 
| Self-paced walking ability at 12 and 24 months. |  | 2 years | 
| Balance at 12 and 24 months. |  | 2 years | 
| Flexibility at 12 and 24 months. |  | 2 years | 
| Breast density at 24 months |  | 2 years | 
| Endometrial thickness at 24 months. |  | 2 years | 
| Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Bone, Exercise, Soy, Isoflavone, Phytoestrogen, Menopause, Lipids