Actively Recruiting

Phase 2
Age: 60Years +
MALE
Healthy Volunteers
NCT06519877

Fiber and Calcium Absorption in Older Men

Led by VA Office of Research and Development · Updated on 2026-02-17

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

S

San Francisco VA Health Care System

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fiber and Calcium Absorption in Older Men

Who Can Participate

Age: 60Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male Veterans 60 years of age
Not Eligible

You will not qualify if you...

  • 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 would compromise the safety of the patient or the quality of the data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States, 94121-1563

Actively Recruiting

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Research Team

K

Karin C Wu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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