NCT06739941

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: One Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Digestive Health
• Metabolic Health

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-15
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2024-12-18
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States