Safety and Efficacy of a Prebiotic Blend in Healthy Humans

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.