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| Name | Class |
|---|---|
| GutWise Inc. (dba LOAM Science) | UNKNOWN |
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This study compares three dietary fiber supplements - LOAM prebiotic fiber, inulin, and a cellulose placebo - to evaluate their effects on intestinal gas production and gastrointestinal comfort in healthy adults who currently eat a low-fiber diet.
Participants will be randomly assigned to one of the three supplements and asked to take one daily serving mixed with water for four weeks. Intestinal gas production will be measured using Ventos, a wearable device that continuously monitors intestinal gas when worn near the body. Participants wear the device for approximately 22 hours on two designated days per week throughout the 5-week study. Gastrointestinal symptoms including bloating, abdominal discomfort, and stool consistency will be tracked daily using a symptom diary and standardized questionnaires.
The study is conducted entirely remotely. Participants receive their supplement and the Ventos device by mail and complete all study activities from home using a smartphone or computer. The study runs for five weeks, including one baseline week before supplementation begins.
The goal is to determine whether LOAM prebiotic fiber causes less intestinal gas and better gastrointestinal tolerability during the initial weeks of supplementation compared to inulin, while also validating the Ventos device as a research measurement tool in a controlled supplement study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOAM | Experimental | 12 grams LOAM prebiotic daily |
|
| Inulin | Active Comparator | 12 grams inulin daily |
|
| Cellulose Placebo | Placebo Comparator | 12 grams cellulose daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOAM | Dietary Supplement | 12 grams of LOAM daily |
| |
| Inulin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin | Average daily flatus as measured by the Ventos wearable intestinal gas monitoring device, defined as the mean of Ventos-measured flatus counts obtained on Tuesday and Saturday of each week. The primary analysis compares the change from Week 1 (baseline, no supplementation) to Week 2 (first week of supplementation) between the LOAM and inulin groups using ANCOVA, with baseline average daily flatus as a covariate. | Baseline (Week 1) to Week 2 (first week of supplementation) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Daily Flatus from Baseline (Week 1) to Weeks 3, 4, and 5 | Average daily flatus as measured by the Ventos wearable intestinal gas monitoring device, defined as the mean of Ventos-measured flatus counts obtained on Tuesday and Saturday of each week. Changes from baseline (Week 1) to Weeks 3, 4, and 5 will be summarized using descriptive statistics and compared between treatment groups using ANCOVA models, with baseline values as covariates. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alethios | San Francisco | California | 94109 | United States |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Dietary Supplement |
12 Grams Inulin daily |
|
| Cellulose Placebo | Dietary Supplement | 12 grams of cellulose placebo daily |
|
| Baseline (Week 1) to Weeks 3, 4, and 5 |
| Comparisons of Average Daily Flatus Between LOAM and Cellulose, and Between Inulin and Cellulose | Average daily flatus as measured by the Ventos wearable intestinal gas monitoring device, defined as the mean of Ventos-measured flatus counts obtained on Tuesday and Saturday of each week. Pairwise comparisons across study arms (LOAM, inulin, cellulose) will be conducted. | Weeks 1 through 5 |
| Microbiome Activity Index | The microbiome activity index is defined as the number of Ventos-derived data points exceeding a standardized threshold, evaluated as change from baseline (Week 1) to Weeks 2, 3, 4, and 5, and as comparisons across LOAM, inulin, and cellulose groups. The microbiome activity index will be interpreted as a proxy measure of intestinal gas volume. | Baseline (Week 1) to Weeks 2, 3, 4, and 5 |
| Daily GI Symptom Diary - Bristol Stool Scale | Stool consistency assessed daily using the Bristol Stool Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models. | Daily over 5 weeks (Days 1-35) |
| Daily GI Symptom Diary - Abdominal Discomfort | Abdominal discomfort assessed daily on a 0-10 Numerical Rating Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models. | Daily over 5 weeks (Days 1-35) |
| Daily GI Symptom Diary - Bloating | Bloating assessed daily on a 0-10 Numerical Rating Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models. | Daily over 5 weeks (Days 1-35) |
| Daily GI Symptom Diary - Intestinal Gas Severity | Intestinal gas severity assessed daily on a 0-10 Numerical Rating Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models. | Daily over 5 weeks (Days 1-35) |
| PROMIS-GI Gas and Bloating 13A Score | The PROMIS-GI Gas and Bloating 13A instrument is a validated, patient-reported outcome measure developed by the National Institutes of Health PROMIS initiative. Scores will be evaluated weekly and as change from baseline to end of study. Administered at baseline (Week 1), Week 2, Week 3, Week 4, and Week 5. | Baseline (Week 1) to Week 5 |
| GAD-7 Score | General psychological well-being assessed using the GAD-7 anxiety screening instrument, evaluated as change from baseline to Week 5. | Baseline (Week 1) to Week 5 |
| Adaptation to Supplementation | Adaptation to supplementation is defined as the change in average daily flatus, as measured by Ventos, from Week 2 to Week 5. LOAM is expected to demonstrate a greater reduction over time compared to inulin. | Week 2 to Week 5 |
| Supplement Compliance | Supplement compliance is defined as the proportion of doses taken per protocol, assessed via daily GI symptom diary supplement intake responses (full dose, partial dose, or missed dose). | Weeks 2 through 5 |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |