Oat Fiber for Digestive Health

Overseen By Katherine M Ng, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: One Bio Inc.

Must not be taking: Prescribed medications

Disqualifiers: Diabetes, Obesity, Crohn's, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take prescribed medications that are likely to influence study measures. If you are on such medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Oat Fiber (BG-OS) for digestive health?

Research shows that oats, which contain beta-glucan, can improve digestive health by increasing stool weight and reducing constipation. Additionally, oats have been found to positively affect the gut microbiome, which is important for overall digestive health. ^{1 2 3 4 5}

Is oat fiber safe for human consumption?

Research shows that oats, including oat fiber, are generally safe for human consumption and have beneficial effects on digestive health. They can improve gut health by altering fecal bacteria and increasing beneficial compounds in the gut. ^{1 5 6 7 8}

How does oat fiber differ from other treatments for digestive health?

Oat fiber, particularly its component beta-glucan, is unique because it can improve gut health by altering fecal bacteria and increasing short-chain fatty acids, which are beneficial for digestion. Unlike other fibers, oat fiber also helps reduce cholesterol and has a specific impact on bile acid excretion, making it a multifaceted option for digestive health. ^{1 4 7 9 10}

What is the purpose of this trial?

The goal of this interventional study is to evaluate the tolerability and potential health benefits of oat fiber oligosaccharide (BG-OS) in healthy adults aged 18-70 years. The main questions it aims to answer are: * Does oat fiber dose impact gastrointestinal tolerability, as assessed by changes in symptoms using the Gastrointestinal Symptom Rating Scale (GSRS)? * Does oat fiber reduce postprandial glucose levels after a white rice challenge? Researchers will compare three groups receiving different doses of oat fiber (5 g, 10 g, and 20 g) to assess dose-related effects. Participants will: * Complete daily surveys on gastrointestinal symptoms, diet, energy, and sleep quality. * Use a continuous glucose monitoring device (CGM) to track glucose levels throughout the study. * Participate in standardized white rice challenge tests to measure glucose uptake during baseline and at one time point during study. * Provide stool samples during baseline and at the end of the study for gut microbiota analysis. * Undergo blood tests for biomarkers like CBC, CMP, and A1C at the beginning and end of the study.

Research Team

Noah Craft, M.D., Ph.D.

Principal Investigator

People Science, Inc.

Eligibility Criteria

This trial is for healthy adults aged 18-70 who want to help test if oat fiber (BG-OS) is easy on the stomach and good for blood sugar control. You can't join if you have digestive disorders, are pregnant or breastfeeding, or have a condition that could affect study results.

Inclusion Criteria

Able to download an app

Language Proficiency: Able to read and understand English

I am capable of understanding and agreeing to the terms of the clinical trial.

Exclusion Criteria

Technology Access: Lack of a smartphone and/or internet access

Pregnancy and Breastfeeding: Pregnant, planning to become pregnant, or currently breastfeeding

Substance Use: Excessive alcohol use or substance abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline

Participants undergo baseline assessments including blood tests, stool sample collection, and initial glucose monitoring

1 week

1 visit (in-person) for initial assessments

Treatment

Participants receive daily doses of oat fiber (5 g, 10 g, or 20 g) and complete daily surveys on gastrointestinal symptoms, diet, energy, and sleep quality

2 weeks

Daily monitoring (home-based)

Follow-up

Participants are monitored for changes in gastrointestinal symptoms, glucose levels, and gut microbiota composition

1 week

1 visit (in-person) for final assessments

Treatment Details

Interventions

• Oat Fiber (BG-OS)

Trial Overview Researchers are testing three different doses of oat fiber (5g, 10g, and 20g) to see how they affect stomach comfort and blood sugar levels after eating white rice. Participants will monitor their glucose continuously, fill out daily health surveys, and provide stool and blood samples.

Participant Groups

Group I: 10 g/day of oat fiber Active Control 1 Intervention

Participants receive 10 g/day of oat fiber (BG-OS) in a single dose.

Group II: 20 g/day of oat fiber Active Control 1 Intervention

Participants receive 20 g/day of oat fiber (BG-OS) in a single dose.

Group III: 5 g/day of oat fiber Active Control 1 Intervention

Participants receive 5 g/day of oat fiber (BG-OS) in a single dose

Who Is Running the Clinical Trial?

One Bio Inc.

Lead Sponsor

Trials

1

Recruited

60+

People Science, Inc.

Industry Sponsor

Trials

7

Recruited

730+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of oats on gastrointestinal health as assessed by in vitro, animal, and human studies. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical response to dietary fiber treatment of chronic constipation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Oats and bowel disease: a systematic literature review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Role of guar fiber in improving digestive health and function. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Concentrated oat beta-glucan, a fermentable fiber, lowers serum cholesterol in hypercholesterolemic adults in a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Food labeling: health claims; soluble dietary fiber from certain foods and coronary heart disease. Final rule. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of oat β-glucan and barley β-glucan on fecal characteristics, intestinal microflora, and intestinal bacterial metabolites in rats. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Food labeling: health claims; soluble dietary fiber from certain foods and coronary heart disease. Final rule. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Oat beta-glucan increases bile acid excretion and a fiber-rich barley fraction increases cholesterol excretion in ileostomy subjects. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Digestion of polysaccharides and other major components in the small and large intestine of pigs fed on diets consisting of oat fractions rich in beta-D-glucan. [2022]