RecruitingNot ApplicableNCT07379645

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

PepZinGI® Crossover Heartburn Clinical Study


Sponsor

NutriScience Innovations, LLC

Enrollment

50 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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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Interventions

DIETARY_SUPPLEMENTPepZinGI

75 mg patented zinc-L-carnosine complex

DIETARY_SUPPLEMENTPlacebo

\<0.1 mg zinc-L-carnosine


Locations(1)

Alethios, Inc

San Francisco, California, United States

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NCT07379645


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