A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes

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.

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