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| Name | Class |
|---|---|
| People Science, Inc. | INDUSTRY |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 20 g/day of oat fiber | Active Comparator | Participants receive 20 g/day of oat fiber (BG-OS) in a single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Description | Time Frame |
|---|---|---|
| Glucose uptake dynamics | Changes in glucose uptake dynamics as measured by a CGM device | During baseline and throughout product use period (From Day 1 up to day 19) |
| Effect on appetite, anxiety, mood | Changes measured by weekly questionnaire that consists of 12 questions on appetite, anxiety and mood. |
Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Noah Craft, M.D., Ph.D. | People Science, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People Science Inc. | Los Angeles | California | 90034 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42358297 | Derived | 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. |
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| 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. | 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). |
| 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 | Changes measured by daily questionnaire that consists of 5 questions on participant experience of change in diet, energy levels and sleep quality. | Daily at baseline and daily throughout product use period (from Day 1 up to Day19) |
| Gut microbial composition | Changes in gut microbiota composition as analyzed by relative abundance of bacterial taxa in the stool samples | Once during baseline period (Day 1 to Day 5) and once at the end of study product use (Day 18 to Day 22) |
| Gut microbial function | Changes in gut microbiota function as analyzed by quantification of key microbial-derived short chain fatty acids in stool samples | Once during baseline period (Day 1 to Day 5) and once at the end of study product use (Day 18 to Day 22) |