Safety and Efficacy of a Prebiotic Blend in Healthy Humans

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Tolerability of 2 Doses of a Prebiotic Fiber Blend in Healthy Individuals

Обзор

The GRASP Trial is a 30-day, randomized, double-blind, placebo-controlled study (Protocol No.: GW-2025-02) designed to evaluate the safety and tolerability of a novel multi-fiber prebiotic blend in healthy adult volunteers (age 18-60, normal BMI). Participants will be randomized (1:1:1) to receive either a low dose (1 dose/day), a high dose (2 doses/day), or an identical placebo powder for 30 days. The primary objective is to evaluate safety and tolerability, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fiber blend's impact on gastrointestinal symptoms (measured by the Gastrointestinal Symptom Rating Scale or GSRS score), beneficial gut microbiome composition (specifically SCFA-producing bacteria like Bifidobacterium spp.), and gut barrier function/inflammation (via markers like LBP, zonulin, hs-CRP, and IL-6). Exploratory objectives will examine effects on sleep and activity patterns using a wearable tracker, as well as quality of life (SF-36) and stress (PSS). The trial includes assessments at baseline (Day 0) and end-of-treatment (Day 28 ± 2), including the collection of blood, urine, and stool samples for comprehensive analysis.

Подробное описание

The GRASP Trial (protocol GW-2025-02) is a randomized, double-blind, placebo-controlled clinical study sponsored by GutWise Inc. (dba LOAM Science). The trial investigates the effects of a multi-fiber prebiotic blend on gastrointestinal comfort, gut microbiome composition, and markers of systemic well-being in healthy adults.

The study follows Good Clinical Practice (GCP) and includes approximately 90 participants allocated equally to three parallel arms: one-dose Fiber Blend, two-dose Fiber Blend, or placebo. Each participant completes a 2-week run-in period followed by a 30-day intervention. The investigational product is a powdered prebiotic formulation containing six well-characterized soluble fibers-Partially Hydrolyzed Guar Gum, Rhamnogalacturonan-I (from carrot), Xylo-oligosaccharides, Resistant Maltodextrin, Tapioca Soluble Fiber, and Wheat Dextrin. The placebo is a visually and organoleptically matched inert powder to ensure blinding integrity.

Participants are healthy men and women aged 18-60 years with normal BMI and no active gastrointestinal disease. Eligible individuals maintain their regular diet and lifestyle and use a wearable tracker to record sleep and activity during the trial.

The study primarily evaluates safety and tolerability, with daily symptom monitoring and predefined adverse-event grading. Secondary and exploratory analyses examine gastrointestinal symptom changes (GSRS), gut microbiota profiles, systemic biomarkers of gut-barrier integrity and inflammation, and quality-of-life and stress metrics (SF-36 and PSS). Objective digital health endpoints (sleep, heart rate, steps) complement biochemical and microbiome measures to explore broader physiological effects of dietary fiber supplementation.

Clinical visits occur at screening, baseline, midpoint, and end of treatment, followed by a brief safety follow-up. Biological samples (blood, urine, stool) are collected at baseline and day 30 for analysis of microbial composition and metabolites, including short-chain fatty acids. Data are captured via secure electronic diaries and the Chloe data platform, ensuring regulatory-grade privacy compliance and data traceability.

Overall, this study aims to characterize how compositional diversity and dosing of a multi-fiber blend influence gastrointestinal comfort, gut microbiome dynamics, and systemic metabolic and neuro-gut signaling markers in healthy adults.

Вмешательства

• Пищевая добавка Fiber Blend 1 (Low Dose)
  One daily dose of the prebiotic fiber blend.
• Пищевая добавка Fiber Blend 2 (High Dose)
  Two daily doses of the prebiotic fiber blend.
• Другое Placebo
  One daily dose of an identical-looking, non-active powder.

Первичные конечные точки

• Incidence and severity of GI adverse events (AEs) and discontinuations. [Срок оценки: 0, 1, 2, 3, 4 weeks]

Вторичные конечные точки (4)

• Change in the Gastrointestinal Symptom Rating Scale (GSRS) total score [Срок оценки: Baseline (Week 0), Week 2, Week 4]
• Gut Microbiome Composition [Срок оценки: 0 and 4 weeks]
• Gut Barrier Function and Inflammation [Срок оценки: 0 and 4 weeks]
• Metabolic and Neurotransmitter Markers [Срок оценки: 0 and 4 weeks]

Критерии участия

Критерии включения

• Healthy adult volunteers aged 18 to 60 years.
• Body mass index (BMI) in the normal range (approximately 18.5-24.9 kg/m²).
• Generally healthy with no active chronic illnesses.
• No significant gastrointestinal disorders (e.g., no diagnosis of irritable bowel syndrome, inflammatory bowel disease, celiac disease, or similar conditions).
• No history of other chronic diseases such as hypertension, hypercholesterolemia, diabetes, or comparable conditions.
• If female, not pregnant or lactating.
• Women of childbearing potential must have a negative pregnancy test at screening and agree to use contraception during the study.
• Willing to maintain their usual diet and lifestyle during the trial.
• Willing to refrain from starting any new supplements or probiotics during the study.
• Willing to consume the study product daily as directed.
• Owns a personal wearable fitness tracker (such as Fitbit or similar) that can be used for the duration of the study.
• Able to provide informed consent.
• Able and willing to comply with all study procedures (including questionnaires, sample collection, and wearing the activity tracker).

Критерии исключения

• Any history of significant gastrointestinal disease or surgery (e.g., inflammatory bowel disease, malabsorption syndromes, or gastrointestinal surgery affecting digestion or absorption) that could confound results or pose risks.
• Use of antibiotics or probiotic/prebiotic supplements in the last 4 weeks.
• Presence of chronic medical conditions such as uncontrolled diabetes, severe allergies, autoimmune diseases, or any condition requiring immunosuppressive therapy.
• Pregnant or breastfeeding.
• Known allergy or intolerance to fiber supplements or any ingredients in the investigational product (e.g., severe wheat allergy or gluten sensitivity related to wheat dextrin content).
• Abnormal screening laboratory values or clinical findings that, in the investigator's opinion, make participation unsafe (e.g., significantly abnormal liver or kidney function tests, anemia).
• Active psychiatric disorders or use of medications that could significantly affect gastrointestinal motility (e.g., chronic opioid therapy) or mood (e.g., certain antidepressants), if these are judged likely to interfere with participation or outcomes.
• Current smoking, heavy smoking, or other tobacco use, if exclusion of smokers is desired to maintain a healthy cohort.
• Excessive alcohol consumption or illicit drug use that may interfere with safety or adherence.
• Participation in another clinical trial of an investigational product or device within the past 30 days.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Next Health — West Hollywood

Идентификаторы

NCT: NCT07514741 · GW-2025-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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