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Safety and Efficacy of a Prebiotic Blend in Healthy Humans
Sponsor: LOAM Science
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Tolerability of 2 Doses of a Prebiotic Fiber Blend in Healthy Individuals
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-04-25
Completion Date
2026-04-25
Last Updated
2026-04-07
Healthy Volunteers
Yes
Conditions
Interventions
Fiber Blend 1 (Low Dose)
One daily dose of the prebiotic fiber blend.
Fiber Blend 2 (High Dose)
Two daily doses of the prebiotic fiber blend.
Placebo
One daily dose of an identical-looking, non-active powder.
Locations (1)
Next Health
West Hollywood, California, United States