Fiber and Calcium Absorption in Older Men

Part of paid clinical trials in San Francisco, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06519877
Phase
PHASE2
Status
Recruiting
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Conditions

  • Aging

Eligibility Criteria

Sex
MALE
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Soluble corn fiber — DIETARY_SUPPLEMENT
    Soluble corn fiber, also referred to resistant maltodextrin, is a type of dietary fiber made from corn starch. Soluble corn fiber is typically used to thicken processed foods and has been marketed as a prebiotic to improve digestive health.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Feb 2026
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Group 1
    Soluble corn fiber 20g/day x 4 weeks, washout period for 4 weeks, and placebo (maltodextrin) x 4 weeks.
  • Experimental: Group 2
    Placebo (maltodextrin) 20g/day x 4 weeks, washout period for 4 weeks, and soluble corn fiber x 4 weeks.

Primary Outcome Measure

Intestinal fractional calcium absorption [ Time Frame: At week 4 and week 12 of study participation (at the end of each treatment phase x2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Karin C Wu, MD
[email protected]
415-221-4810
Karin C Wu, MD (PRINCIPAL_INVESTIGATOR)

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