NCT07514741
Safety and Efficacy of a Prebiotic Blend in Healthy Humans
Enrolling by Invitation
NAAges 18–60InterventionalPreventionLOAM ScienceInvestigator-initiated
~90 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Fiber Blend 1 (Low Dose)Fiber Blend 2 (High Dose)Placebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of GI adverse events (AEs) and discontinuations.
Measured over 0, 1, 2, 3, 4 weeks
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Incidence and severity of GI adverse events (AEs) and discontinuations.0, 1, 2, 3, 4 weeks
To evaluate the safety and tolerability of the fiber blend.