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Safety and Efficacy of a Prebiotic Blend in Healthy Humans

NCT07514741 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Healthy Adult Participants

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.

Sponsors & Collaborators

  • People Science, Inc.

    collaborator INDUSTRY

  • LOAM Science

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-25
Primary Completion
2026-04-25
Completion
2026-04-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514741 on ClinicalTrials.gov