Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LOAM
12 grams LOAM prebiotic daily
干预措施: LOAM (Dietary Supplement)
Cellulose Placebo
12 grams cellulose daily
干预措施: Cellulose Placebo (Dietary Supplement)
Inulin
12 grams inulin daily
干预措施: Inulin (Dietary Supplement)
结局指标
主要结局
Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin
时间窗: 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.
次要结局
- Change in Average Daily Flatus from Baseline (Week 1) to Weeks 3, 4, and 5(Baseline (Week 1) to Weeks 3, 4, and 5)
- Comparisons of Average Daily Flatus Between LOAM and Cellulose, and Between Inulin and Cellulose(Weeks 1 through 5)
- Microbiome Activity Index(Baseline (Week 1) to Weeks 2, 3, 4, and 5)
- Daily GI Symptom Diary - Bristol Stool Scale(Daily over 5 weeks (Days 1-35))
- Daily GI Symptom Diary - Abdominal Discomfort(Daily over 5 weeks (Days 1-35))
- Daily GI Symptom Diary - Bloating(Daily over 5 weeks (Days 1-35))
- Daily GI Symptom Diary - Intestinal Gas Severity(Daily over 5 weeks (Days 1-35))
- PROMIS-GI Gas and Bloating 13A Score(Baseline (Week 1) to Week 5)
- GAD-7 Score(Baseline (Week 1) to Week 5)
- Adaptation to Supplementation(Week 2 to Week 5)
- Supplement Compliance(Weeks 2 through 5)
研究者
Andrew Brantley Hall
Co-Founder
Ventoscity LLC