Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort

Обзор

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.

Вмешательства

• Пищевая добавка LOAM
  12 grams of LOAM daily
• Пищевая добавка Inulin
  12 Grams Inulin daily
• Пищевая добавка Cellulose Placebo
  12 grams of cellulose placebo daily

Первичные конечные точки

• Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin [Срок оценки: Baseline (Week 1) to Week 2 (first week of supplementation)]

Вторичные конечные точки (11)

• Change in Average Daily Flatus from Baseline (Week 1) to Weeks 3, 4, and 5 [Срок оценки: Baseline (Week 1) to Weeks 3, 4, and 5]
• Comparisons of Average Daily Flatus Between LOAM and Cellulose, and Between Inulin and Cellulose [Срок оценки: Weeks 1 through 5]
• Microbiome Activity Index [Срок оценки: Baseline (Week 1) to Weeks 2, 3, 4, and 5]
• Daily GI Symptom Diary - Bristol Stool Scale [Срок оценки: Daily over 5 weeks (Days 1-35)]
• Daily GI Symptom Diary - Abdominal Discomfort [Срок оценки: Daily over 5 weeks (Days 1-35)]
• Daily GI Symptom Diary - Bloating [Срок оценки: Daily over 5 weeks (Days 1-35)]
• Daily GI Symptom Diary - Intestinal Gas Severity [Срок оценки: Daily over 5 weeks (Days 1-35)]
• PROMIS-GI Gas and Bloating 13A Score [Срок оценки: Baseline (Week 1) to Week 5]
• GAD-7 Score [Срок оценки: Baseline (Week 1) to Week 5]
• Adaptation to Supplementation [Срок оценки: Week 2 to Week 5]
• Supplement Compliance [Срок оценки: Weeks 2 through 5]

Критерии участия

Критерии включения

• Male or female adults aged 18 to 65 years
• Body mass index 18.5 to 30 kg/m2
• Habitual daily fiber intake of fewer than 10 grams per day, as self-reported at screening
• No current use of fiber supplements, prebiotic supplements, or probiotic supplements
• No use of fiber supplements, prebiotics, probiotics, or antibiotics within the past 4 months
• Willing and able to consume one daily fiber supplement (mixed with water) for the duration of the study
• 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
• Willing and able to complete daily and weekly digital questionnaires and symptom diaries using the Alethios platform
• Access to a smartphone or computer with internet access
• Able to read and understand English
• 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
• Willing to maintain habitual diet, physical activity, and body weight throughout the trial
• Willing to refrain from exclusionary medications, supplements, and products throughout the study
• Willing to provide informed consent electronically
• Not currently enrolled in any other clinical trial, supplement study, or consumer health research study

Критерии исключения

• 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)
• Perception that they have more than 40 flatus per day
• Currently undergoing chemotherapy or any other treatment that affects the digestive system
• Known allergy or sensitivity to any ingredient in the study supplement
• Unwilling to discontinue any current fiber supplement use at least 14 days prior to study initiation
• Habitual dietary fiber intake of 10 or more grams per day
• 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
• Participation in another research study within 30 days prior to screening that could confound study outcomes
• Recent history (within 12 months of screening) of alcohol or substance abuse
• Habitual use (daily) of marijuana and hemp products including CBD products within 30 days of screening
• Currently or planning to be on a weight loss regimen during the study
• Use of weight loss medications, incretin mimetics, and/or GLP-1 agonists in the 3 months prior to screening
• Chronic use (daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of screening
• Expected to receive a COVID-19 vaccine during the study period
• Antibiotic use within 3 months of screening and throughout the study period
• Any medical condition that would make participation unsafe or interfere with data quality
• Currently pregnant or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Alethios — San Francisco

Идентификаторы

NCT: NCT07525180 · LOA002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗