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

NCT06739941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Digestive Health
  • Metabolic Health

Interventions

OTHER

Oat fiber (BG-OS)

Beta-glucan oligosaccharide (BG-OS) is beta-glucan predominant, dietary fiber obtained by extracting oat fiber from oat grain and applying a food-grade depolymerization process to shorten the polysaccharide chain length of the fiber. BG-OS retains the fiber structure of oat fiber but has a shorter chain length, which makes it water soluble and easily formulated into any food.

Sponsors & Collaborators

  • People Science, Inc.

    collaborator INDUSTRY

  • One Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Noah Craft, M.D., Ph.D. · People Science, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-04-25
Completion
2025-04-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06739941 on ClinicalTrials.gov