An interventional study of PepZinGI and Placebo in Heartburn, sponsored by NutriScience Innovations, LLC. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by NutriScience Innovations, LLC · Not applicable, Interventional, and Other
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.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Browse Heartburn studies →This is the only study on the registry with NutriScience Innovations, LLC as lead sponsor.
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Exclusion Criteria:
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
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
75 mg patented zinc-L-carnosine complex
\<0.1 mg zinc-L-carnosine
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
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.
Time frame: Baseline through Day 29
Sleep quality measured by wearable sleep devices
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.
Time frame: Baseline through Day 29
Resting heart rate measured by wearable sleep devices
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.
Time frame: Baseline through Day 29
Heart rate variability measured by wearable sleep devices
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.
Time frame: Baseline through Day 29
Awake/restlessness moments measured by wearable sleep devices
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.
Time frame: Baseline through Day 29
Participant satisfaction measured by phase completion questionnaires
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.
Time frame: Day 8 and Day 29
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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