Safety and Efficacy of a Prebiotic Blend in Healthy Humans

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Healthy Adult Participants

In brief

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 facts

Study ID

NCT07514741

Run by

LOAM Science

People needed

90

Starts

2026-04-25

Expected to finish

2026-04-25

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Next Health — West Hollywood, California, United States

Full record on ClinicalTrials.gov

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