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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how varying amounts of oat fiber (BG-OS) affect digestive health and blood sugar control. It aims to determine if oat fiber influences stomach comfort and impacts blood sugar levels after consuming white rice. Participants will test different doses of oat fiber to identify the most effective amount. Healthy adults without digestive or metabolic issues, who are willing to monitor their symptoms and glucose levels, are ideal candidates. As an unphased trial, this study allows participants to contribute to foundational research on the health benefits of oat fiber.

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 prior data suggests that oat fiber is safe for digestive health?

Research has shown that oat fiber is generally safe for people. In past studies, most participants tolerated it well, although some experienced minor digestive issues like gas or bloating, which is common with high fiber intake.

There is no strict limit on fiber consumption, but large amounts can cause stomach problems, such as gas and diarrhea. This study tests different amounts of oat fiber (5 g, 10 g, and 20 g) to observe reactions and any digestive side effects.

Overall, oat fiber is considered safe and beneficial for gut health. It promotes the growth of good bacteria in the gut, which can improve digestion. When considering participation in a trial with oat fiber, the main factor is how the body might react to different amounts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Oat Fiber (BG-OS) is unique because it's a natural dietary option aimed at improving digestive health, unlike many standard treatments like laxatives or probiotics. Researchers are excited about it because oat fiber is known for its ability to support gut health by promoting regular bowel movements and enhancing beneficial bacteria growth. Additionally, the study explores varying doses (5g, 10g, and 20g per day), which could help determine the most effective amount for improving digestion. This approach offers a potentially simpler, natural alternative to current digestive health treatments, with fewer side effects.

What evidence suggests that oat fiber might be an effective treatment for digestive health?

Research has shown that oat fiber benefits gut health. Studies have found that oat fiber increases the number and variety of beneficial bacteria in the gut, which is crucial for digestion. Eating oats is also linked to higher levels of short-chain fatty acids, which improve nutrient absorption in the gut. Although evidence supports these benefits, no major changes in overall quality of life have been noted. This trial will test different amounts of oat fiber, with participants receiving either 5 g/day, 10 g/day, or 20 g/day, to determine if these varying doses can affect symptoms like bloating and help control blood sugar levels after meals. ^{1 3 4 6 7}

Who Is on the Research Team?

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

Principal Investigator

People Science, Inc.

Are You a Good Fit for This Trial?

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

Language Proficiency: Able to read and understand English

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

Able to download an app

Exclusion Criteria

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

Substance Use: Excessive alcohol use or substance abuse

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10459712/

Relationship between Oat Consumption, Gut Microbiota ... A healthy diet, rich in fiber, can beneficially modulate the gut microbiota. In this sense, oats are a source of both soluble and insoluble ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06739941

NCT06739941 | Investigating the Tolerability of Oat Fiber ... The rationale for this study is to determine the gastrointestinal tolerability of a food-grade fiber obtained from oat (BG-OS) in healthy participants.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622003765

Systematic Review of the Effects of Oat Intake on ... There was an increased concentration of short-chain fatty acids and improved gut permeability with oat intake but with no significant quality-of-life difference ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06739941?term=AREA%5BBasicSearch%5D(BG%2012)&rank=4

Investigating the Tolerability of Oat Fiber (BG-OS) in ... The goal of this interventional study is to evaluate the tolerability and potential health benefits of oat fiber oligosaccharide ( BG -OS) in healthy adults ...

5. mdpi.com mdpi.com/2072-6643/17/15/2481

Oat Fiber Alleviates Loperamide-Induced Constipation in ... Gut microbiota analysis revealed that oat fiber increased both the abundance and diversity of gut microbiota in constipated mice. Specifically, oat fiber was ...

6. portlandcleanair.org portlandcleanair.org/files/merge/msds/OAT_FIBER_POWDER.PDF

Material Safety Data Sheet RightFiber Oat Fiber Ingestion: May cause slight gastrointestinal irritation. Skin Contact ... In general, dilution ventilation is a satisfactory health hazard control for this.

7. nature.com nature.com/articles/s41522-025-00759-x

Oat bran fiber protects against radiation-induced disruption ... Our findings suggest that fiber deprivation exacerbates radiation-induced intestinal damage, while supplementation with 15% highly fermentable oat bran fiber ...