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

NCT07379645 | Recruiting

• 1 other identifier: NSCI01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PepZinGI; heartburn; reflux; crossover; wearable sleep metrics

Outcome Measures

Primary Outcomes (3)

• Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a

  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

  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

  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 Outcomes (6)

• Sleep duration measured by wearable sleep devices

  Baseline through Day 29

• Sleep quality measured by wearable sleep devices

  Baseline through Day 29

• Resting heart rate measured by wearable sleep devices

  Baseline through Day 29

• Heart rate variability measured by wearable sleep devices

  Baseline through Day 29

• Awake/restlessness moments measured by wearable sleep devices

  Baseline through Day 29

Study Arms (2)

Arm 1: PepZinGI

EXPERIMENTAL

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

Arm 2: Placebo

EXPERIMENTAL

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

Interventions

PepZinGI DIETARY_SUPPLEMENT

75 mg patented zinc-L-carnosine complex

Arm 1: PepZinGI

Placebo DIETARY_SUPPLEMENT

\<0.1 mg zinc-L-carnosine

Arm 2: Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NutriScience Innovations, LLC: lead
• Alethios, Inc.: collaborator

Study Sites (1)

Alethios, Inc

San Francisco, California, 94104, United States

RECRUITING

MeSH Terms

Conditions

Heartburn; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Edward Dosz, Ph.D

CONTACT

(203) 372-8877; edosz@nutriscienceusa.com

Zoe Benham, B.S

CONTACT

(956) 277-1765; zoe@alethios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 30, 2026
• Study Start: January 15, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)