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

NCT06739941 | Completed

• 1 other identifier: Pro00074413
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oat fiber; dietary fiber; beta-glucan; Gastrointestinal tolerability; oat oligosaccharides

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal symptoms

  Change in gastrointestinal symptoms as measured by mean total score on the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS comprises 15 items, each rated on a Likert scale from 1 (no discomfort) to 7 (severe discomfort). Higher total scores indicate worse gastrointestinal symptoms

  On day 5, day 12 and day 19

Secondary Outcomes (2)

• Change in Postprandial Glucose Uptake after a white rice challenge (iAUC)

  Day 3 (baseline), Day 6 (after first use of study product), Day 12 (after 1 week of use of study product), and Day 19 (end of intervention, after 2 weeks of use of study product).

• Change in Postprandial Glucose Uptake after a white rice challenge (Peak Glucose levels)

  Day 3 (baseline), Day 6 (after first use of study product), Day 12 (after 1 week of use of study product), and Day 19 (end of intervention, after 2 weeks of use of study product).

Other Outcomes (5)

• Glucose uptake dynamics

  During baseline and throughout product use period (From Day 1 up to day 19)

• Effect on appetite, anxiety, mood

  Day 5 (baseline), Day 12 (after 1 week of use of study product), and Day 19 (end of intervention, after 2 weeks of use of study product).

• Gastrointestinal symptoms, sleep quality, energy levels, change in diet

  Daily at baseline and daily throughout product use period (from Day 1 up to Day19)

Study Arms (3)

5 g/day of oat fiber

ACTIVE COMPARATOR

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

10 g/day of oat fiber

ACTIVE COMPARATOR

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

Other: Oat fiber (BG-OS)

20 g/day of oat fiber

ACTIVE COMPARATOR

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

Other: Oat fiber (BG-OS)

Interventions

Oat fiber (BG-OS) OTHER

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.

Also known as: Oat beta-glucan oligosaccharides

10 g/day of oat fiber; 20 g/day of oat fiber

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• One Bio Inc.: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science Inc.

Los Angeles, California, 90034, United States

Location

Study Officials

• Noah Craft, M.D., Ph.D.

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: January 15, 2025
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)