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

NCT07379645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Heartburn

Interventions

DIETARY_SUPPLEMENT

PepZinGI

75 mg patented zinc-L-carnosine complex

DIETARY_SUPPLEMENT

Placebo

\<0.1 mg zinc-L-carnosine

Sponsors & Collaborators

  • Alethios, Inc.

    collaborator INDUSTRY

  • NutriScience Innovations, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2026-05-11
Completion
2026-05-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07379645 on ClinicalTrials.gov