Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease
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ClinicalTrials.gov Identifier: NCT00366860 |
Recruitment Status
:
Completed
First Posted
: August 21, 2006
Last Update Posted
: December 2, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Cardiovascular Diseases | Behavioral: Soy bread | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: Soy bread
Soy bread (75-100 mg isoflavone/day) for 12 weeks
|
Behavioral: Soy bread |
Active Comparator: Wheat bread
Wheat bread for 12 weeks
|
Behavioral: Soy bread |
- deoxypyridinoline [ Time Frame: 12 weeks ]Urinary deoxypyridinoline
- N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, cholesterol, triglycerides, apolipoproteins, C-reactive protein, HbA1c [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Post-menopausal women and men who were 50 years of age or older.
Exclusion Criteria:
- Allergy to soy, wheat, and/or nuts. Use of hormone replacement therapy within the past 6 months. Diagnosis of osteoporosis or use of bone loss medications. Use of drugs within the past 3 months which increase the risk of osteoporosis. End-stage renal disease or other nephropathies. Chemotherapy within the past 6 months. Active gastrointestinal disorders. Diagnosis of thyroid disorder. Use of cholesterol-lowering medications within the past month. Vitamin, mineral, protein, and/or calorie deficiency. Alcoholism, acute or chronic hepatitis, cirrhosis. Use of systemic antibiotics within the past 6 months. Currently under dietary restrictions that would conflict with the intervention. Anticipated mental or physical incapability of adhering to the dietary protocol during the time period of the study (e.g. expected travel).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366860
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Mary A.M. Rogers, PhD | University of Michigan |
Responsible Party: | Mary A.M. Rogers, Research Associate Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT00366860 History of Changes |
Other Study ID Numbers: |
GCRC Protocol #1971 |
First Posted: | August 21, 2006 Key Record Dates |
Last Update Posted: | December 2, 2014 |
Last Verified: | December 2014 |
Keywords provided by Mary A.M. Rogers, University of Michigan:
soy isoflavones bone resorption |
osteogenesis diet hyperlipidemia |
Additional relevant MeSH terms:
Cardiovascular Diseases Osteoporosis Bone Diseases, Metabolic |
Bone Diseases Musculoskeletal Diseases Metabolic Diseases |