Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort (NCT07525180) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort
United States125 participantsStarted 2026-04-15
Plain-language summary
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.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Male or female adults aged 18 to 65 years
ā. Body mass index 18.5 to 30 kg/m2
ā. Habitual daily fiber intake of fewer than 10 grams per day, as self-reported at screening
ā. No current use of fiber supplements, prebiotic supplements, or probiotic supplements
ā. No use of fiber supplements, prebiotics, probiotics, or antibiotics within the past 4 months
ā. Willing and able to consume one daily fiber supplement (mixed with water) for the duration of the study
ā. 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
ā. Willing and able to complete daily and weekly digital questionnaires and symptom diaries using the Alethios platform
Exclusion criteria
ā4. Willing to provide informed consent electronically
What they're measuring
1
Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin
Timeframe: Baseline (Week 1) to Week 2 (first week of supplementation)
ā5. Not currently enrolled in any other clinical trial, supplement study, or consumer health research study
ā. 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)
ā. Perception that they have more than 40 flatus per day
ā. Currently undergoing chemotherapy or any other treatment that affects the digestive system
ā. Known allergy or sensitivity to any ingredient in the study supplement
ā. Unwilling to discontinue any current fiber supplement use at least 14 days prior to study initiation
ā. Habitual dietary fiber intake of 10 or more grams per day