Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | August 17, 2006 | ||||
| Last Updated Date | August 17, 2006 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
deoxypyridinoline | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, cholesterol, triglycerides, apolipoproteins, C-reactive protein, HbA1c | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease | ||||
| Official Title ICMJE | Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease | ||||
| 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 bread consumption affects the metabolism of phytoestrogens. To answer Aim 1, a double-blind randomized crossover trial was conducted. Individuals with an ability to metabolize a specific isoflavone, daidzein, consumed 3 slices of bread (either soy or wheat) daily over a 12-week period. After a 4-week wash-out period, subjects consumed 3 slices/day of the other type of bread. Markers of bone metabolism and cardiovascular health were evaluated before and after each time period. To answer Aim 2, individuals who did not metabolize daidzein at baseline entered a double-blind randomized trial of soy bread with or without fructooligosaccharide (a type of dietary fiber) over an 8-week period. Subjects were evaluated regarding their ability to metabolize daidzein to equol. |
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| 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 metabolism are less well known. The National Aeronautics and Space Administration expressed an interest in the effects of soy on bone loss and a former NASA scientist developed a soy product, soy bread, which may be more palatable for most Americans than currently available soy foods. A two-treatment two-period crossover trial was conducted to assess the effects of soy bread consumption on deoxypyridinoline, N-telopeptides, bone-specific alkaline phosphatase, osteocalcin, calcium, leptin, insulin-like growth factor-1, luteinizing hormone, follicle-stimulating hormone, testosterone, cholesterol (total, HDL, LDL), triglycerides, apolipoprotein AI, apolipoprotein B, C-reactive protein, and glycosylated hemoglobin. The crossover trial was conducted in subjects identified as having the ability to metabolize daidzein to equol. The treatment was 3 servings of soy bread daily over a 12-week period. The control period included 3 servings of a placebo wheat bread over a 12-week period. For subjects who did not metabolize daidzein to equol at baseline, a pretest-posttest trial of soy bread consumption over an 8-week period was conducted to examine whether 3 servings/day of soy bread increased urinary equol concentrations and whether the addition of fructooligosaccharide enhanced this excretion. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Soy bread | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | May 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00366860 | ||||
| Other Study ID Numbers ICMJE | GCRC Protocol #1971 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | Ohio State University | ||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | August 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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