Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort

Ventoscity LLC

Status: Not yet enrolling

Conditions: Healthy Participants

Treatments: Dietary Supplement: Cellulose Placebo; Dietary Supplement: Inulin; Dietary Supplement: LOAM

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07525180

LOA002

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 3 patient groups, including a placebo group

LOAM

Experimental group

Description:

12 grams LOAM prebiotic daily

Treatment:

Dietary Supplement: LOAM

Inulin

Active Comparator group

Description:

12 grams inulin daily

Treatment:

Dietary Supplement: Inulin

Cellulose Placebo

Placebo Comparator group

Description:

12 grams cellulose daily

Treatment:

Dietary Supplement: Cellulose Placebo