Effects of soluble corn fiber on calcium absorption in older men
Modulation of the Gut Microbiome by Dietary Fiber to Improve Calcium Absorption and Bone Health in Older Men
This study is testing whether adding soluble corn fiber to the diet can help older men absorb more calcium and support their bone health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | Male |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06519877 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates how soluble corn fiber affects intestinal calcium absorption and the gut microbiome in older male Veterans aged 60 and above. The study aims to determine whether dietary fiber can enhance calcium absorption, potentially mitigating age-related bone loss and reducing the risk of osteoporotic fractures. By employing a crossover design, participants will receive both soluble corn fiber and a placebo, allowing for direct comparison of effects. The study will also explore the role of the gut microbiome in this process, focusing on the production of short-chain fatty acids and their influence on calcium metabolism.
Who should consider this trial
Good fit: Ideal candidates for this study are male Veterans aged 60 years or older without conditions that affect calcium metabolism or gut microbiota.
Not a fit: Patients with malabsorption issues, hypercalcemia, or those on medications affecting calcium metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve bone health and reduce fracture risk in older men.
How similar studies have performed: While studies have shown dietary fiber's effects on calcium absorption in other populations, this specific approach in older men is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male Veterans 60 years of age Exclusion Criteria: * 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.
Where this trial is running
San Francisco, California
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Karin C Wu, MD — San Francisco VA Medical Center, San Francisco, CA
- Study coordinator: Karin C Wu, MD
- Email: karin.Wu@va.gov
- Phone: (415) 221-4810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.