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ENROLLING BY INVITATION
NCT07514741
NA

Safety and Efficacy of a Prebiotic Blend in Healthy Humans

Sponsor: LOAM Science

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Next Health

West Hollywood, California, United States