Completed
PepZinGI Crossover Heartburn Clinical Study
Led by NutriScience Innovations, LLC · Updated on 2026-06-17
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NutriScience Innovations, LLC
Lead Sponsor
A
Alethios, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This decentralized, randomized, double-blind, placebo-controlled, two-period crossover study will evaluate whether PepZinGI® (zinc-L-carnosine) reduces food-triggered heartburn compared with placebo. Participants (N=50) complete two 1-week treatment periods (PepZinGI® and placebo) separated by a 2-week washout, for a total of 29 days. Primary outcomes are heartburn severity and frequency measured by the NutriScience Heartburn Questionnaire; secondary outcomes include PROMIS GI Reflux-13a, time to relief, rescue medication use, wearable-derived sleep metrics, Karolinska Sleep Scale, sleep diary entries, and satisfaction. All activities are remote through Alethios; no in-person visits.
CONDITIONS
Brief Title
A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes
Who Can Participate
Eligibility Criteria
Inclusion Criteria:
- Age ≥21 years
- Self-reported food-triggered heartburn with known trigger foods
- Heartburn at least once per week
- Willing to avoid OTC/supplement heartburn treatments during study (calcium-carbonate rescue allowed but must be logged and not used during hurdle-meal day/night)
- Able to complete electronic surveys and adhere to procedures
- Access to or willingness to use a compatible wearable device
Exclusion Criteria:
- Clinician-diagnosed GERD, UC, Crohn's, or IBD
- Prescribed drugs for heartburn/digestive conditions
- Heartburn less than once per week or daily throughout the month
- More than 1 alcoholic drink/day on average during study
- Recreational drug use during study
- Known allergy to zinc, L-carnosine, or study ingredients
- Pregnant or breastfeeding
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