Safety and Efficacy of a Prebiotic Blend in Healthy Humans (GRASP)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Other: Placebo; Dietary supplement: Fiber Blend 1 (Low Dose); Dietary supplement: Fiber Blend 2 (High Dose)

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • West Hollywood, California, United States, 90069
      • Next Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adult volunteers aged 18 to 60 years.
• Body mass index (BMI) in the normal range (approximately 18.5-24.9 kg/m²).
• Generally healthy with no active chronic illnesses.
• No significant gastrointestinal disorders (e.g., no diagnosis of irritable bowel syndrome, inflammatory bowel disease, celiac disease, or similar conditions).
• No history of other chronic diseases such as hypertension, hypercholesterolemia, diabetes, or comparable conditions.
• If female, not pregnant or lactating.
• Women of childbearing potential must have a negative pregnancy test at screening and agree to use contraception during the study.
• Willing to maintain their usual diet and lifestyle during the trial.
• Willing to refrain from starting any new supplements or probiotics during the study.
• Willing to consume the study product daily as directed.
• Owns a personal wearable fitness tracker (such as Fitbit or similar) that can be used for the duration of the study.
• Able to provide informed consent.
• Able and willing to comply with all study procedures (including questionnaires, sample collection, and wearing the activity tracker).

Exclusion Criteria:

• Any history of significant gastrointestinal disease or surgery (e.g., inflammatory bowel disease, malabsorption syndromes, or gastrointestinal surgery affecting digestion or absorption) that could confound results or pose risks.
• Use of antibiotics or probiotic/prebiotic supplements in the last 4 weeks.
• Presence of chronic medical conditions such as uncontrolled diabetes, severe allergies, autoimmune diseases, or any condition requiring immunosuppressive therapy.
• Pregnant or breastfeeding.
• Known allergy or intolerance to fiber supplements or any ingredients in the investigational product (e.g., severe wheat allergy or gluten sensitivity related to wheat dextrin content).
• Abnormal screening laboratory values or clinical findings that, in the investigator's opinion, make participation unsafe (e.g., significantly abnormal liver or kidney function tests, anemia).
• Active psychiatric disorders or use of medications that could significantly affect gastrointestinal motility (e.g., chronic opioid therapy) or mood (e.g., certain antidepressants), if these are judged likely to interfere with participation or outcomes.
• Current smoking, heavy smoking, or other tobacco use, if exclusion of smokers is desired to maintain a healthy cohort.
• Excessive alcohol consumption or illicit drug use that may interfere with safety or adherence.
• Participation in another clinical trial of an investigational product or device within the past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; One daily dose of an identical-looking, non-active powder.	Other: 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.	Dietary supplement: 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.	Dietary supplement: Fiber Blend 2 (High Dose); Two daily doses of the prebiotic fiber blend.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of GI adverse events (AEs) and discontinuations.	To evaluate the safety and tolerability of the fiber blend.	0, 1, 2, 3, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Gastrointestinal Symptom Rating Scale (GSRS) total score	The Gastrointestinal Symptom Rating Scale (GSRS) is a validated patient-reported questionnaire assessing gastrointestinal symptoms across 15 items grouped into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation). Each item is rated on a 7-point Likert scale, where 1 = no discomfort and 7 = very severe discomfort. The total GSRS score ranges from 15 to 105, with higher scores indicating worse gastrointestinal symptoms (poorer outcome).	Baseline (Week 0), Week 2, Week 4
Gut Microbiome Composition	Changes in alpha diversity and relative abundance of SCFA-producing bacteria (e.g., Faecalibacterium prausnitzii, Bifidobacterium spp.).	0 and 4 weeks
Gut Barrier Function and Inflammation	Changes in serum markers including lipopolysaccharide-binding protein (LBP), zonulin, hs-CRP, and IL-6.	0 and 4 weeks
Metabolic and Neurotransmitter Markers	Fecal short-chain fatty acids (SCFAs) (butyrate, acetate, propionate) and Plasma or urine GABA.	0 and 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time	Total sleep time (minutes per night) measured by a validated wearable tracker. Higher values indicate longer sleep duration (better outcome).	Continuous measurement throughout the 30 days; data downloaded at Day 30
Quality of Life (SF-36 Total Score)	The 36-Item Short Form Health Survey (SF-36) is a validated questionnaire assessing eight domains of health-related quality of life, including physical functioning, bodily pain, general health, vitality, social functioning, and mental health. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life (better outcome).	Baseline (Week 0), Week 2, and Week 4
Bristol Stool Form Scale	Daily stool type (1-7) to assess stool normalization/GI motility.	Daily tracking throughout the intervention (Days 1-30).
Perceived Stress (PSS Total Score)	The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire that measures the degree to which situations in one's life are appraised as stressful. Each item is rated on a 5-point Likert scale (0 = never to 4 = very often), yielding a total score from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).	Baseline (Week 0), Week 2, and Week 4
Sleep Efficiency	Sleep efficiency calculated as the ratio of total sleep time to time in bed, expressed as a percentage (%). Higher percentages indicate better sleep quality (better outcome).	Continuous measurement throughout the 30 days; data downloaded at Day 30
Resting Heart Rate	Mean resting heart rate (beats per minute) measured by a validated wearable device. Lower values indicate better cardiovascular fitness (better outcome).	Continuous measurement throughout the 30 days; data downloaded at Day 30
Daily Step Count	Mean daily step count (steps per day) measured by a wearable tracker. Higher values indicate higher physical activity (better outcome).	Continuous measurement throughout the 30 days; data downloaded at Day 30

Collaborators and Investigators

• Sponsor: LOAM Science
• Collaborators: People Science, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2026
• Primary Completion (Estimated): April 25, 2026
• Study Completion (Estimated): April 25, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: health; prebiotic; microbiome
• Other Study ID Numbers: GW-2025-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is propriatery data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No