Safety and Efficacy of a Prebiotic Blend in Healthy Humans

Part of paid clinical trials in West Hollywood, California.

Sponsor
LOAM Science
Study ID
NCT07514741
Status
Enrolling By Invitation

Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 25, 2026
Status verified
Apr 2026
Primary completion
Apr 25, 2026
Completion
Apr 25, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo
    One daily dose of an identical-looking, non-active powder.
  • Active Comparator: Arm 1: Fiber Blend 1 (Low Dose)
    One daily dose of the prebiotic fiber blend.
  • Active Comparator: Arm 2: Fiber Blend 2 (High Dose)
    Two daily doses of the prebiotic fiber blend.

Primary Outcome Measure

Incidence and severity of GI adverse events (AEs) and discontinuations. [ Time Frame: 0, 1, 2, 3, 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Next HealthWest HollywoodCalifornia90069-

Find similar trials in West Hollywood, CA

By research site
Next Health· West Hollywood, CA

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