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Completed

NCT Number: NCT06739941

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

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.

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Key information

Conditions

Digestive Health Metabolic Health

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

People Science Inc.

Los Angeles, California, 90034, United States

About this study

The rationale for this study is to determine the gastrointestinal tolerability of a food-grade fiber obtained from oat (BG-OS) in healthy participants. Additionally, the study aims to observe the effects of the BG-OS on glucose uptake (as measured by Continuous Glucose Monitors or CGM) after a dietary challenge with cooked white rice, other potential health benefits of oat, and gut microbiota via activities and technologies that can successfully and effectively be completed and utilized in a home setting.

Outcomes will be examined in a broad age-range of adults who have chosen to try these products. The study incorporates participant reported outcomes and surveys, the use of a CGM device and carbohydrate (white rice) dietary challenge tests, at-home stool collection and standard blood sample collection for complete blood count (CBC), comprehensive metabolic panel (CMP) tests, and A1C hemoglobin test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Oat beta-glucan oligosaccharides

Primary outcomes

  1. Gastrointestinal symptoms

    Time frame: On day 5, day 12 and day 19

    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

Secondary outcomes

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

    Time frame: 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 measured by incremental Area Under the Curve (iAUC) using data from a Continuous Glucose Monitoring (CGM) device.

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

    Time frame: 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 peak glucose levels measured using a Continuous Glucose Monitoring (CGM) device.

Other outcomes

  1. Glucose uptake dynamics

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

    Changes in glucose uptake dynamics as measured by a CGM device

  2. Effect on appetite, anxiety, mood

    Time frame: 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).

    Changes measured by weekly questionnaire that consists of 12 questions on appetite, anxiety and mood.

  3. Gastrointestinal symptoms, sleep quality, energy levels, change in diet

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

    Changes measured by daily questionnaire that consists of 5 questions on participant experience of change in diet, energy levels and sleep quality.

  4. Gut microbial composition

    Time frame: Once during baseline period (Day 1 to Day 5) and once at the end of study product use (Day 18 to Day 22)

    Changes in gut microbiota composition as analyzed by relative abundance of bacterial taxa in the stool samples

  5. Gut microbial function

    Time frame: Once during baseline period (Day 1 to Day 5) and once at the end of study product use (Day 18 to Day 22)

    Changes in gut microbiota function as analyzed by quantification of key microbial-derived short chain fatty acids in stool samples

Sponsors and collaborators

Lead sponsor

One Bio Inc.

Industry

Collaborators

  • People Science, Inc.

Registry information

Official study title

A Direct-to-Consumer, Open-label Study Investigating the Tolerability of BG-OS in Healthy Individuals in a Home Setting

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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