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

NutriScience Innovations, LLC50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Heartburn

Interventions

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Day 8 and Day 29

Secondary Outcomes

Sleep duration measured by wearable sleep devices

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.