Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort

N/ANot Yet RecruitingNCT07525180

Ventoscity LLC125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

125

Conditions

Healthy Participants

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Male or female adults aged 18 to 65 years 2. Body mass index 18.5 to 30 kg/m2 3. Habitual daily fiber intake of fewer than 10 grams per day, as self-reported at screening 4. No current use of fiber supplements, prebiotic supplements, or probiotic supplements 5. No use of fiber supplements, prebiotics, probiotics, or antibiotics within the past 4 months 6. Willing and able to consume one daily fiber supplement (mixed with water) for the duration of the study 7. Willing and able to wear the Ventos intestinal gas monitoring device for approximately 22 hours on designated monitoring days (Tuesdays and Saturdays) for the full 5-week study period 8. Willing and able to complete daily and weekly digital questionnaires and symptom diaries using the Alethios platform 9. Access to a smartphone or computer with internet access 10. Able to read and understand English 11. Non-user (never used, or former user defined as cessation 12 or more months) of tobacco or nicotine products with no plans to begin use during the study period 12. Willing to maintain habitual diet, physical activity, and body weight throughout the trial 13. Willing to refrain from exclusionary medications, supplements, and products throughout the study 14. Willing to provide informed consent electronically 15. Not currently enrolled in any other clinical trial, supplement study, or consumer health research study Exclusion Criteria 1. Diagnosis of any gastrointestinal condition, including but not limited to IBS, IBD (Crohn's Disease or Ulcerative Colitis), celiac disease, diverticulitis, gastroparesis, clinically significant lactose or gluten intolerance or other food or ingredient allergies, or any chronic or acute GI condition requiring medical management (e.g., GERD) 2. Perception that they have more than 40 flatus per day 3. Currently undergoing chemotherapy or any other treatment that affects the digestive system 4. Known allergy or sensitivity to any ingredient in the study supplement 5. Unwilling to discontinue any current fiber supplement use at least 14 days prior to study initiation 6. Habitual dietary fiber intake of 10 or more grams per day 7. Consumption of supplemental inulin/chicory root or inulin/chicory root-fortified foods and beverages equivalent to more than 10 g inulin per day within 1 month of screening 8. Participation in another research study within 30 days prior to screening that could confound study outcomes 9. Recent history (within 12 months of screening) of alcohol or substance abuse 10. Habitual use (daily) of marijuana and hemp products including CBD products within 30 days of screening 11. Currently or planning to be on a weight loss regimen during the study 12. Use of weight loss medications, incretin mimetics, and/or GLP-1 agonists in the 3 months prior to screening 13. Chronic use (daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of screening 14. Expected to receive a COVID-19 vaccine during the study period 15. Antibiotic use within 3 months of screening and throughout the study period 16. Any medical condition that would make participation unsafe or interfere with data quality 17. Currently pregnant or breastfeeding

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Week 1) to Week 2 (first week of supplementation)

Secondary Outcomes

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.

Time frame: Baseline (Week 1) to Weeks 3, 4, and 5

Comparisons of Average Daily Flatus Between LOAM and Cellulose, and Between Inulin and Cellulose

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Weeks 2 through 5

Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes