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Sponsors and Collaborators: |
United States Department of Agriculture University of Connecticut |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00668447 |
The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or soy isoflavones on bone mineral density in late postmenopausal women.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Dietary Supplement: Soy Isolate Dietary Supplement: Control protein Dietary Supplement: Novasoy isoflavones Dietary Supplement: Placebo tablets |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study |
Official Title: | Soy Proteins and Isoflavones Impact Bone Mineral Density in Older Women |
Enrollment: | 97 |
Study Start Date: | November 2001 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Soy protein and isoflavone tablets
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Dietary Supplement: Soy Isolate
20 grams of powder mixed in beverages or food daily for one year
Dietary Supplement: Novasoy isoflavones
3 tablets daily for one year
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2: Active Comparator
Soy protein and placebo tablets
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Dietary Supplement: Soy Isolate
20 grams of powder mixed in beverages or food daily for one year
Dietary Supplement: Placebo tablets
3 tablets daily for one year
|
3: Active Comparator
control protein and Isoflavone tablets
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Dietary Supplement: Control protein
20 grams of powder mixed in beverages or food daily for one year
Dietary Supplement: Novasoy isoflavones
3 tablets daily for one year
|
4: Placebo Comparator
control protein and placebo tablets
|
Dietary Supplement: Control protein
20 grams of powder mixed in beverages or food daily for one year
Dietary Supplement: Placebo tablets
3 tablets daily for one year
|
Although soy foods contain several components (isoflavones and amino acids) that could potentially have positive effects on bone health, there are few long term, large, clinical trials using soy as a means of improving bone mineral density. The objective of this study is to provide daily soy protein and isoflavones to healthy older women in order to answer three major questions:
We hypothesize that soy protein will have a beneficial effect on bone in older women compared to control protein. Further, we hypothesize that there will be an additional benefit to bone in women who receive soy protein plus isoflavones (at both doses) compared to soy protein alone.
Both control and soy proteins used in the study were isolates, meaning they were the highest concentration of protein (85-90% by weight) in order to minimize the volume of protein supplement that each woman was asked to ingest on a daily basis. The soy protein was an alcohol-washed, soy protein isolate containing 90% protein and negligible isoflavone (0.2 mg/g product). The control protein was a mix consisting of 50% protein from sodium caseinate, 25% protein from whey protein and 25% from egg white protein. The use of a mix of proteins as a control provides a more balanced level of amino acids, mimics the real life mix of proteins that humans typically consume, and avoids the unique characteristics of one source of protein. In order to maintain the dietary protein intake constant, the participant was counseled to decrease her intake of other sources of protein from primarily animal sources by approximately 3 ounces per day (the approximate equivalent of the protein powders). The isoflavones tablets each contained 57 mg of total isoflavone from primarily genistein, glycitein, and daidzein and their beta-glycosides.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 |
Principal Investigator: | Jane Kerstetter, PhD | Department of Allied Health Sciences, University of Connecticut |
Responsible Party: | University of Connecticut Center on Aging ( Anne Kenny, MD, Associate Professor of Medicine ) |
Study ID Numbers: | AG0102, USDA CONR-2001-00630 |
Study First Received: | April 25, 2008 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00668447 |
Health Authority: | United States: Federal Government |
bone density bone loss postmenopausal |
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |