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

April 6, 2026 updated by: NutriScience Innovations, LLC

PepZinGI® Crossover Heartburn Clinical Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94104
        • Recruiting
        • Alethios, Inc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edward Dosz, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: PepZinGI
Participants will take PepZinGI for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period.
Dietary supplement: PepZinGI
75 mg patented zinc-L-carnosine complex
Experimental: Arm 2: Placebo
Participants will take placebo for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period.
Dietary supplement: Placebo
<0.1 mg zinc-L-carnosine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a
Time Frame: Baseline, Day 8, and Day 29
Participant will select the frequency (Never, One Day, 2-6 days, Once a day, More than once a day) of heartburn related symptoms, if any. The data will be compared to baseline and day after hurdle meals for active and placebo. A lower frequency corresponds with a better outcome.
Baseline, Day 8, and Day 29
Participant sleep quality measured by Karolinska Sleep Scale
Time Frame: Baseline, Day 8, and Day 29
The validated 9-point scale will measure a participant's current level of sleepiness. The data will be compared to baseline and day after hurdle meal for active and placebo. The minimum value 1 denotes "extremely alert" whereas a 9 denotes "very sleepy". A lower score corresponds with a better outcome.
Baseline, Day 8, and Day 29
Heartburn severity measured by NutriScience Heartburn Questionnaire
Time Frame: Day 8 and Day 29
Participants will rank severity of heartburn related symptoms (1: None, 2: A little bit, 3: Quite a bit, 4: A lot, 5: Extremely), if any. Participant data will be compared to PepZinGI and placebo supplementation. A lower value will correspond with a better outcome.
Day 8 and Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep duration measured by wearable sleep devices
Time Frame: Baseline through Day 29
Participant sleep duration in total hours and minutes will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Increased sleep duration will be considered a better outcome.
Baseline through Day 29
Sleep quality measured by wearable sleep devices
Time Frame: Baseline through Day 29
Participant sleep quality score will be acquired from wearable devices (Garmin, Apple Watch, WHOOP) with a range from 0 to 100. Data will be compared amongst study arms. Increased sleep quality score will be considered a better outcome.
Baseline through Day 29
Resting heart rate measured by wearable sleep devices
Time Frame: Baseline through Day 29
Participant resting heart rate in beats per minute will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Decreased resting heart rate will be considered a better outcome.
Baseline through Day 29
Heart rate variability measured by wearable sleep devices
Time Frame: Baseline through Day 29
Participant heart rate variability reflected as time between heartbeats in milliseconds will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Increased heart rate variability will be considered a better outcome.
Baseline through Day 29
Awake/restlessness moments measured by wearable sleep devices
Time Frame: Baseline through Day 29
Participant awake/restlessness measured through number of awakenings throughout total sleep duration will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Decreased awake/restlessness will be considered a better outcome.
Baseline through Day 29
Participant satisfaction measured by phase completion questionnaires
Time Frame: Day 8 and Day 29
Participant satisfaction and perceived effectiveness will be measured by product evaluation questions (taste, recommendation level, purchasing incentive) on a sliding scale from 1 to 10 with a higher number reflecting more positive views. Data from each question will be added to obtain a satisfaction score. Increased satisfaction scores will be considered a better outcome.
Day 8 and Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NutriScience Innovations, LLC

Collaborators

Alethios, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSCI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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