Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519877
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-20
Brief Title:
Fiber and Calcium Absorption in Older Men
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Modulation of the Gut Microbiome by Dietary Fiber to Improve Calcium Absorption and Bone Health in Older Men
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoporotic fractures are a major but underrecognized problem in men There is growing evidence that low dietary fiber intake is a modifiable risk factor for age-related bone loss in men Preclinical and human studies in adolescents and postmenopausal women suggest that dietary fiber intake influences bone metabolism by modulating the gut microbiome to augment intestinal calcium absorption but it is unclear through what molecular mechanism and whether dietary fiber has the same effects in older men In this crossover intervention study the investigators will enroll and follow 30 older male Veterans to evaluate the effects of soluble corn fiber on intestinal calcium absorption and explore the contribution of the gut microbiome
Detailed Description:
Osteoporosis and associated fractures are a major problem in older men One in four men over the age of 60 will sustain an osteoporotic fracture during his lifetime Moreover the mortality rate in men after fractures is nearly twice that in women Despite the burden of fractures little is understood about the pathogenesis of progressive bone loss in men Studies point to dietary fiber as a potentially important mitigator of decline in bone mass likely through increased intestinal calcium absorption and retention as studied in adolescents young men and postmenopausal women However the effects of dietary fiber in older men have not been tested and the mechanism by which dietary fiber influences calcium absorption is unclear The gut microbiome which is crucial for host nutrient metabolism and hormone modulation is a likely but underexplored mechanism
The overall objective is to examine the effects of soluble corn fiber on intestinal calcium absorption with modulation of the gut microbiome in older men The central hypothesis is that soluble corn fiber augments production of short-chain fatty acids by the gut microbiome which modulates the production of systemic insulin-like growth factor 1 to increase calcium absorption and bone mass
This study is a crossover intervention study on the effects of soluble corn fiber vs placebo on intestinal calcium absorption and gut microbiome composition and function in 30 older male Veterans 60 years of age Participants will be randomized 11 to sequential soluble corn fiber 20gday vs placebo for 4 weeks each with a 4-week washout period Individualized doses of calcium and vitamin D supplementation will also be provided throughout the study period Study measurements at the end of each intervention include intestinal calcium absorption via a dual stable isotope method detailed gut microbiome characterization with metagenomics and metabolomics dietary assessment calciotropic hormones and bone turnover marker levels Baseline bone density and microstructure will also be obtained
The overall objective is to examine the effects of soluble corn fiber on intestinal calcium absorption with modulation of the gut microbiome in older men The central hypothesis is that soluble corn fiber augments production of short-chain fatty acids by the gut microbiome which modulates the production of systemic insulin-like growth factor 1 to increase calcium absorption and bone mass
This study is a crossover intervention study on the effects of soluble corn fiber vs placebo on intestinal calcium absorption and gut microbiome composition and function in 30 older male Veterans 60 years of age Participants will be randomized 11 to sequential soluble corn fiber 20gday vs placebo for 4 weeks each with a 4-week washout period Individualized doses of calcium and vitamin D supplementation will also be provided throughout the study period Study measurements at the end of each intervention include intestinal calcium absorption via a dual stable isotope method detailed gut microbiome characterization with metagenomics and metabolomics dietary assessment calciotropic hormones and bone turnover marker levels Baseline bone density and microstructure will also be obtained
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