Investigating the Tolerability of Oat Fiber (BG-OS) in Healthy Individuals

Completed · Not applicable

Conditions studied: Digestive Health, Metabolic Health

In brief

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.

Key facts

Study ID

NCT06739941

Run by

One Bio Inc.

People needed

60

Starts

2025-01-15

Expected to finish

2025-04-25

Last updated by the study team

2025-09-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age: Healthy adults aged 18 to 70 years.
• Language Proficiency: Able to read and understand English.
• Informed Consent: Capable of providing informed consent.
• Technology Access: Must have a personal smartphone device.
• Able to download an app
• Study Commitment: Willing and able to complete all study assessments over a period of up to 7 weeks.

You may not qualify if…

• Technology Access: Lack of a smartphone and/or internet access.
• Medical Conditions:
• Significant abnormal laboratory values (CBC, CMP, or A1C ≥ 6.5%) at screening.
• Diagnosed with gastrointestinal, digestive, or metabolic diseases, including:
• Crohn's disease Ulcerative colitis Irritable bowel syndrome Celiac disease Gluten allergy Diabetes Obesity Significant illness, disease, or condition that may interfere with study participation or outcomes, as determined by the principal investigator.
• Allergies: Known allergic reactions to any component of the study product or rice challenge product.
• Medications: Prescribed medications likely to influence study measures.
• Diet and Supplements:
• Use of fiber supplements within 30 days prior to enrollment or during the study.
• Major changes in diet or exercise 30 days prior to enrollment or during the study.
• Antibiotics Use: Use of antibiotics within 30 days prior to enrollment or during the study.
• Pregnancy and Breastfeeding: Pregnant, planning to become pregnant, or currently breastfeeding.
• Substance Use: Excessive alcohol use or substance abuse.
• Compliance Concerns: Unlikely to comply with the study protocol for any reason, as determined by the principal investigator.

Where it is running

• People Science Inc. — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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