Alethios
San Francisco, California, 94109, United States
NCT Number: NCT07525180
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
San Francisco, California, 94109, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 grams of LOAM daily
12 Grams Inulin daily
12 grams of cellulose placebo daily
Time frame: Baseline (Week 1) to Week 2 (first week of supplementation)
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.
Time frame: 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.
Time frame: Weeks 1 through 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. Pairwise comparisons across study arms (LOAM, inulin, cellulose) will be conducted.
Time frame: Baseline (Week 1) to Weeks 2, 3, 4, and 5
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.
Time frame: Daily over 5 weeks (Days 1-35)
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.
Time frame: Daily over 5 weeks (Days 1-35)
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.
Time frame: Daily over 5 weeks (Days 1-35)
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.
Time frame: Daily over 5 weeks (Days 1-35)
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.
Time frame: Baseline (Week 1) to Week 5
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.
Time frame: Baseline (Week 1) to Week 5
General psychological well-being assessed using the GAD-7 anxiety screening instrument, evaluated as change from baseline to Week 5.
Time frame: Week 2 to Week 5
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.
Time frame: Weeks 2 through 5
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).
Ventoscity LLC
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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