Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366860
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2006-08-17
Brief Title:
Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Effect of Soy Bread on Markers of Bone Metabolism and Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 slicesday 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
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 servingsday of soy bread increased urinary equol concentrations and whether the addition of fructooligosaccharide enhanced this excretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None