Status:
COMPLETED
Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Ohio State University
Conditions:
Osteoporosis
Cardiovascular Diseases
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
A study was designed with two specific aims: (1) to assess the effect of soy bread, compared with wheat bread, on markers of bone metabolism and cardiovascular health, and (2) to evaluate whether soy ...
Detailed Description
Soy beans are rich in isoflavones, such as genistein and daidzein, which exhibit estrogenic activity. While the cardiovascular benefits of isoflavones in soy have been recognized, the effects on bone ...
Eligibility Criteria
Inclusion
- Post-menopausal women and men who were 50 years of age or older.
Exclusion
- 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).
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00366860
Start Date
January 1 2004
End Date
May 1 2008
Last Update
December 2 2014
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109