Soluble Corn Fiber for Aging

Overseen By Karin C Wu, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Karin C Wu, MD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for male Veterans who are 60 years or older. It's designed to study how a dietary component, soluble corn fiber, might affect their body's ability to absorb calcium and potentially impact bone health as they age.

Inclusion Criteria

I am a male Veteran aged 60 or older.

Exclusion Criteria

Severe hypogonadism (AM fasting serum total testosterone < 150 ng/dL)

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

I use proton pump inhibitors daily.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive soluble corn fiber 20g/day or placebo for 4 weeks

4 weeks

End of phase visit for measurements

Washout

Participants undergo a 4-week washout period between treatment phases

4 weeks

Treatment Phase 2

Participants receive the alternate treatment (placebo or soluble corn fiber) for 4 weeks

4 weeks

End of phase visit for measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Soluble corn fiber

Trial Overview The study is testing the effects of soluble corn fiber on calcium absorption in the intestines of older men. Researchers will also explore how this fiber influences the gut microbiome, which may play a role in bone metabolism.

Participant Groups

Group I: Group 2 Experimental Treatment 1 Intervention

Placebo (maltodextrin) 20g/day x 4 weeks, washout period for 4 weeks, and soluble corn fiber x 4 weeks.

Group II: Group 1 Experimental Treatment 1 Intervention

Soluble corn fiber 20g/day x 4 weeks, washout period for 4 weeks, and placebo (maltodextrin) x 4 weeks.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

San Francisco VA Health Care System

Collaborator

Trials

11

Recruited

865,000+