Healthy Adult ParticipantsGRASPNCT07514741
Safety and Efficacy of a Prebiotic Blend in Healthy Humans
A study testing Fiber Blend 1 (Low Dose) and Fiber Blend 2 (High Dose) in people with Healthy Adult Participants, run by LOAM Science at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Fiber Blend 1 (Low Dose) and Fiber Blend 2 (High Dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2026to 19 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Adult Participants
- Being tested
- Fiber Blend 1 (Low Dose), Fiber Blend 2 (High Dose), Placebo
- Keywords
- microbiome, prebiotic, health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
One daily dose of an identical-looking, non-active powder.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One daily dose of an identical-looking, non-active powder. Receives: Other: Placebo |
| Arm 1: Fiber Blend 1 (Low Dose) | Active comparator | One daily dose of the prebiotic fiber blend. Receives: Dietary Supplement: Fiber Blend 1 (Low Dose) |
| Arm 2: Fiber Blend 2 (High Dose) | Active comparator | Two daily doses of the prebiotic fiber blend. Receives: Dietary Supplement: Fiber Blend 2 (High Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of GI adverse events (AEs) and discontinuations.
To evaluate the safety and tolerability of the fiber blend.
Measured: 0, 1, 2, 3, 4 weeks
Secondary outcomes (4)
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).
Measured: 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.).
Measured: 0 and 4 weeks
Gut Barrier Function and Inflammation
Changes in serum markers including lipopolysaccharide-binding protein (LBP), zonulin, hs-CRP, and IL-6.
Measured: 0 and 4 weeks
Metabolic and Neurotransmitter Markers
Fecal short-chain fatty acids (SCFAs) (butyrate, acetate, propionate) and Plasma or urine GABA.
Measured: 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start25 Apr 2026
- Primary completion19 Aug 2026
- Study completion19 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- LOAM Science
- Sponsor type
- University, hospital or other
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514741
- Sponsor's protocol ID
- GW-2025-02
- Acronym
- GRASP
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is propriatery data
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07514741
- Acronym / sponsor ID
- GRASP / GW-2025-02
- Conditions
- Healthy Adult Participants
- Keywords
- microbiome, prebiotic, health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- LOAM ScienceUniversity, hospital or other
- Collaborators
- People Science, Inc.
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 19 Aug 2026 (actual)
- Study completion
- 19 Aug 2026 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboOne daily dose of an identical-looking, non-active powder. |
| Arm 1: Fiber Blend 1 (Low Dose) | Active comparator | Dietary Supplement: Fiber Blend 1 (Low Dose)One daily dose of the prebiotic fiber blend. |
| Arm 2: Fiber Blend 2 (High Dose) | Active comparator | Dietary Supplement: Fiber Blend 2 (High Dose)Two daily doses of the prebiotic fiber blend. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber Blend 1 (Low Dose)One daily dose of the prebiotic fiber blend. | Dietary supplement | Arm 1: Fiber Blend 1 (Low Dose) |
| Fiber Blend 2 (High Dose)Two daily doses of the prebiotic fiber blend. | Dietary supplement | Arm 2: Fiber Blend 2 (High Dose) |
| PlaceboOne daily dose of an identical-looking, non-active powder. | Other | Placebo |
Primary outcome
Incidence and severity of GI adverse events (AEs) and discontinuations.
Time frame: 0, 1, 2, 3, 4 weeks
To evaluate the safety and tolerability of the fiber blend.
4 secondary outcomes
Change in the Gastrointestinal Symptom Rating Scale (GSRS) total score
Time frame: Baseline (Week 0), Week 2, Week 4
Gut Microbiome Composition
Time frame: 0 and 4 weeks
Gut Barrier Function and Inflammation
Time frame: 0 and 4 weeks
Metabolic and Neurotransmitter Markers
Time frame: 0 and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. The data is propriatery data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber Blend 1 (Low Dose) and Fiber Blend 2 (High Dose) in people with Healthy Adult Participants, run by LOAM Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of GI adverse events (AEs) and discontinuations. (time frame: 0, 1, 2, 3, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.