RecruitingPhase 2NCT06519877

Fiber and Calcium Absorption in Older Men

Modulation of the Gut Microbiome by Dietary Fiber to Improve Calcium Absorption and Bone Health in Older Men


Sponsor

VA Office of Research and Development

Enrollment

30 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 60 Years

Inclusion Criteria1

  • Male Veterans 60 years of age

Exclusion Criteria9

  • History of malabsorption
  • Hypercalcemia (corrected Ca > 10.2 mg/dL)
  • Vitamin D insufficiency (25OHD < 30 ng/mL)
  • Chronic kidney disease stage 3B or worse (CrCl < 45 mL/min)
  • Severe hypogonadism (AM fasting serum total testosterone < 150 ng/dL)
  • Daily use of proton pump inhibitor
  • Use of medication(s) known to affect calcium metabolism
  • Use of medications or supplements that could impact gut microbiota in the previous 3 months (antibiotics or commercially available probiotics or prebiotics.
  • Presence of a condition or abnormality that in the opinion of the Investigator that would compromise the safety of the patient or the quality of the data.

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Interventions

DIETARY_SUPPLEMENTSoluble corn fiber

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.


Locations(1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

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NCT06519877


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