Clinical trial NCT06739941: Investigating the Tolerability of Oat Fiber (BG-OS) in Healthy Individuals
Official title: A Direct-to-Consumer, Open-label Study Investigating the Tolerability of BG-OS in Healthy Individuals in a Home Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Digestive Health
Metabolic Health
Keywords: oat fiber
dietary fiber
beta-glucan
Gastrointestinal tolerability
oat oligosaccharides
Lead sponsor: One Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: People Science, Inc.
First posted: 2024-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: On day 5, day 12 and day 19
Secondary outcomes:
measure: Change in Postprandial Glucose Uptake after a white rice challenge (iAUC)
timeFrame: 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).
measure: Change in Postprandial Glucose Uptake after a white rice challenge (Peak Glucose levels)
timeFrame: 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:
measure: Glucose uptake dynamics
timeFrame: During baseline and throughout product use period (From Day 1 up to day 19)
measure: Effect on appetite, anxiety, mood
timeFrame: 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).
measure: Gastrointestinal symptoms, sleep quality, energy levels, change in diet
timeFrame: Daily at baseline and daily throughout product use period (from Day 1 up to Day19)
measure: Gut microbial composition
timeFrame: Once during baseline period (Day 1 to Day 5) and once at the end of study product use (Day 18 to Day 22)
measure: Gut microbial function
timeFrame: Once during baseline period (Day 1 to Day 5) and once at the end of study product use (Day 18 to Day 22)
Locations:
city: Los Angeles
country: United States
facility: People Science Inc.
state: California
Study officials:
affiliation: People Science, Inc.
name: Noah Craft, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: