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

Must not be taking: Proton pump inhibitors, Antibiotics

Disqualifiers: Malabsorption, Hypercalcemia, Vitamin D insufficiency, Chronic kidney disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether soluble corn fiber can help older men improve bone health by increasing calcium absorption. Researchers believe dietary fiber might strengthen bones, especially in men at risk of fractures. Participants will take the fiber supplement and a placebo in different phases to determine any noticeable effects. This study suits male veterans aged 60 or older who do not have severe kidney disease or use medications affecting calcium or gut health. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications or supplements that affect calcium metabolism or impact gut microbiota, such as antibiotics or probiotics, for at least 3 months before joining.

Is there any evidence suggesting that soluble corn fiber is likely to be safe for humans?

Research has shown that soluble corn fiber is generally well-tolerated in human trials. Previous studies have linked this fiber to improved health and a reduced risk of certain diseases. Although specific side effects are not detailed in the available information, its success in earlier human trials suggests it is safe for consumption. Additionally, soluble corn fiber is a common dietary fiber found in many foods and is not typically associated with serious side effects. This history of use supports its safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bone loss?

Researchers are excited about soluble corn fiber for aging because it offers a natural and dietary approach to improving gut health and potentially other age-related issues. Unlike traditional supplements or medications for aging that might involve synthetic compounds, soluble corn fiber is a prebiotic fiber that helps promote the growth of beneficial gut bacteria. This natural mechanism can lead to improved digestion and overall health, which may be especially beneficial as we age. Plus, it's generally well-tolerated and easy to incorporate into the diet, making it a promising option for enhancing quality of life in older adults.

What evidence suggests that soluble corn fiber might be an effective treatment for age-related bone loss in men?

This trial will compare the effects of soluble corn fiber and a placebo on bone and gut health. Research has shown that soluble corn fiber might improve bone health. In earlier studies, daily intake of soluble corn fiber increased calcium retention in the bones of postmenopausal women by about 50%. This suggests potential benefits for older men as well. It also helped teenagers absorb more calcium, aiding in building strong bones. Additionally, it increased beneficial gut bacteria in healthy men. These findings suggest that soluble corn fiber could support bone health by enhancing calcium absorption and improving gut health. ^{4 6 7 8 9}

Who Is on the Research Team?

Karin C Wu, MD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. medrxiv.org medrxiv.org/content/10.1101/2025.06.12.25329532v1

Soluble Corn Fiber Consumption Effects Executive ... This study evaluated the effects of soluble corn fiber (SCF) on cognition, gastrointestinal microbiota composition, and fermentation end-products.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947079/

Age-Dependent Prebiotic Effects of Soluble Corn Fiber in ... A clinical study reported a significant increase in Bifidobacterium spp. in healthy men who consumed 21 g/d SCF for 21 days versus those who did not [7].

3. withpower.com withpower.com/trial/soluble-corn-fiber-for-aging-a1e81

Soluble Corn Fiber for Aging 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 ...

4. purdue.edu purdue.edu/newsroom/archive/releases/2016/Q3/soluble-corn-fiber-can-help-young-women-build-bone,-and-older-women-preserve-bone.html

Soluble corn fiber can help young women build bone, and ... Daily SCF consumption significantly increased bone calcium retention in postmenopausal women, improving bone calcium balance by an estimated 50 ...

5. researchgate.net researchgate.net/publication/392664169_Soluble_Corn_Fiber_Consumption_Effects_Executive_Functions_and_Gut_Microbiota_in_Middle_to_Older_Age_Adults_A_Randomized_Controlled_Crossover_Trial

Soluble Corn Fiber Consumption Effects Executive ... Background: Dietary soluble corn fiber (SCF) significantly improves calcium absorption in adolescents and the bone strength and architecture in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06519877

NCT06519877 | Fiber and Calcium Absorption in Older Men This study is a crossover intervention study on the effects of soluble corn fiber vs. placebo on intestinal calcium absorption and gut microbiome ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5733116/

Effects of Soluble Corn Fiber Alone or in Synbiotic ... The aging process leads to a potential decline in immune function and adversely affects the gut microbiota. To date, many in vitro and in vivo ...

8. tateandlyle.com tateandlyle.com/sites/default/files/2025-01/soluble-corn-fibre-science-behind-health-benefits.pdf

Soluble Corn Fibre: The science behind the health benefits Research indicates that diets higher in fibre are associated with improved health and reduced risk of certain diseases, including.

9. medrxiv.org medrxiv.org/content/10.1101/2025.06.12.25329532v2.full

Effects of Soluble Corn Fiber Consumption on Executive ... Dietary fiber is associated with reduced risk of obesity, cardiovascular disease, type 2 diabetes, and colon cancer, yet nearly 95% of ...