Digestive HealthNCT06739941
Investigating the Tolerability of Oat Fiber (BG-OS) in Healthy Individuals
A study testing Oat fiber (BG-OS) in people with Digestive Health and Metabolic Health, run by One Bio Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health, Metabolic Health
- What is being tested?
- Oat fiber (BG-OS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 25 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Direct-to-Consumer, Open-label Study Investigating the Tolerability of BG-OS in Healthy Individuals in a Home Setting
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Digestive Health, Metabolic Health
- Being tested
- Oat fiber (BG-OS)
- Keywords
- oat fiber, dietary fiber, beta-glucan, Gastrointestinal tolerability, oat oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat fiber (BG-OS)Other
Also called Oat beta-glucan oligosaccharides
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Oat fiber (BG-OS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: On day 5, day 12 and day 19
Secondary outcomes (2)
Change in Postprandial Glucose Uptake after a white rice challenge (iAUC)
Change in postprandial glucose uptake measured by incremental Area Under the Curve (iAUC) using data from a Continuous Glucose Monitoring (CGM) device.
Measured: 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)
Change in peak glucose levels measured using a Continuous Glucose Monitoring (CGM) device.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start15 Jan 2025
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digestive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- One Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, M.D., Ph.D., Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739941
- Sponsor's protocol ID
- Pro00074413
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marcobal AM, Ng KM, Drexler RA, McConnell BR, Amicucci MJ. Short-chain oat fiber improves gastrointestinal tolerance and regulates glucose metabolism: a two-week open-label study in healthy adults. Front Nutr. 2026 Jun 10;13:1745303. doi: 10.3389/fnut.2026.1745303. eCollection 2026.
PubMed 42358297
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Direct-to-Consumer, Open-label Study Investigating the Tolerability of BG-OS in Healthy Individuals in a Home Setting
- ClinicalTrials.gov ID
- NCT06739941
- Acronym / sponsor ID
- Pro00074413
- Conditions
- Digestive Health, Metabolic Health
- Keywords
- oat fiber, dietary fiber, beta-glucan, Gastrointestinal tolerability, oat oligosaccharides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- One Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Oat fiber (BG-OS)Participants receive 10 g/day of oat fiber (BG-OS) in a single dose. |
| 20 g/day of oat fiber | Active comparator | Other: Oat fiber (BG-OS)Participants receive 20 g/day of oat fiber (BG-OS) in a single dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Technology Access: Lack of a smartphone and/or internet access.
- Medical Conditions:
- Significant abnormal laboratory values (CBC, CMP, or A1C ≥ 6.5%) at screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oat fiber (BG-OS)Also: Oat beta-glucan oligosaccharidesBeta-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 | 10 g/day of oat fiber, 20 g/day of oat fiber |
Primary outcome
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
2 secondary outcomes
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 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 42358297Marcobal AM, Ng KM, Drexler RA, McConnell BR, Amicucci MJ. Short-chain oat fiber improves gastrointestinal tolerance and regulates glucose metabolism: a two-week open-label study in healthy adults. Front Nutr. 2026 Jun 10;13:1745303. doi: 10.3389/fnut.2026.1745303. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, M.D., Ph.D. principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oat fiber (BG-OS) in people with Digestive Health and Metabolic Health, run by One Bio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms (time frame: On day 5, day 12 and day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06739941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.