NCT07514741

Safety and Efficacy of a Prebiotic Blend in Healthy Humans

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: LOAM Science · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fiber Blend 1 (Low Dose)	One daily dose of the prebiotic fiber blend.
DIETARY_SUPPLEMENT	Fiber Blend 2 (High Dose)	Two daily doses of the prebiotic fiber blend.
OTHER	Placebo	One daily dose of an identical-looking, non-active powder.

Timeline

• Start date: 2026-04-25
• Primary completion: 2026-04-25
• Completion: 2026-04-25
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States