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.

NCT Number	NCT07379645
Lead Sponsor	NutriScience Innovations, LLC Collaborators: Alethios, Inc.
Conditions	Heartburn
Enrollment	50 participants
Start Date	2026-01-15
Primary Completion	2026-05-11 (estimated)
Study Completion	2026-05-11 (estimated)
Updated on ClinicalTrials.gov	2026-06-17