Status:
RECRUITING
Fiber and Calcium Absorption in Older Men
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
San Francisco VA Health Care System
Conditions:
Aging
Eligibility:
MALE
60+ years
Phase:
PHASE2
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...
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 me...
Eligibility Criteria
Inclusion
- Male Veterans 60 years of age
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06519877
Start Date
January 1 2025
End Date
January 1 2029
Last Update
March 12 2025
Active Locations (1)
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1
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563