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Completed

NCT Number: NCT07379645

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.

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Key information

Conditions

Heartburn Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alethios, Inc

San Francisco, California, 94104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PepZinGI

Dietary Supplement

75 mg patented zinc-L-carnosine complex

Placebo

Dietary Supplement

<0.1 mg zinc-L-carnosine

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

NutriScience Innovations, LLC

Industry

Collaborators

  • Alethios, Inc.

Registry information

Official study title

PepZinGI® Crossover Heartburn Clinical Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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