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A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes
Sponsor: NutriScience Innovations, LLC
Summary
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.
Official title: PepZinGI® Crossover Heartburn Clinical Study
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-01-15
Completion Date
2026-07-01
Last Updated
2026-01-30
Healthy Volunteers
Yes
Conditions
Interventions
PepZinGI
75 mg patented zinc-L-carnosine complex
Placebo
\<0.1 mg zinc-L-carnosine