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| ID | Type | Description | Link |
|---|---|---|---|
| 124322 FRN68095 |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | exercise/soy isoflavone |
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| 2 | Experimental | exercise/isoflavone placebo |
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| 3 | Experimental | exercise placebo/soy isoflavone |
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| 4 | Placebo Comparator | exercise placebo/isoflavone placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise/soy isoflavone | Dietary Supplement | Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine bone mineral density at 12 and 24 months | 2 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip D Chilibeck, PhD | University of Saskatchewan | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saskatchewan | Saskatoon | Saskatchewan | S7N 5B2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15001805 | Background | 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. doi: 10.1139/h04-006. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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 |
| D001519 | Behavior |