RECRUITING

Fiber and Calcium Absorption in Older Men

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-01
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06519877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male Veterans 60 years of age
  1. * History of malabsorption
  2. * Hypercalcemia (corrected Ca \> 10.2 mg/dL)
  3. * Vitamin D insufficiency (25OHD \< 30 ng/mL)
  4. * Chronic kidney disease stage 3B or worse (CrCl \< 45 mL/min)
  5. * Severe hypogonadism (AM fasting serum total testosterone \< 150 ng/dL)
  6. * Daily use of proton pump inhibitor
  7. * Use of medication(s) known to affect calcium metabolism
  8. * Use of medications or supplements that could impact gut microbiota in the previous 3 months (antibiotics or commercially available probiotics or prebiotics.
  9. * 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.

Contacts and Locations

Study Contact

Karin C Wu, MD
CONTACT
(415) 221-4810
karin.Wu@va.gov

Principal Investigator

Karin C Wu, MD
PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA

Study Locations (Sites)

San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Karin C Wu, MD, PRINCIPAL_INVESTIGATOR, San Francisco VA Medical Center, San Francisco, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2025-01-01
Study Completion Date2029-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Aging