Actively Recruiting
PepZinGI45 Crossover Clinical Study to Evaluate Food-Triggered Heartburn Relief and Sleep Outcomes
Led by NutriScience Innovations, LLC · Updated on 2026-04-13
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
NutriScience Innovations, LLC
Lead Sponsor
A
Alethios, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating PepZinGI45, a zinc-L-carnosine dietary supplement, to see if it reduces food-triggered heartburn compared with placebo. This randomized, double-blind, placebo-controlled crossover study includes adults with self-reported food-triggered heartburn occurring at least once per week. The study also examines sleep outcomes related to heartburn, using various questionnaires and wearable device metrics. Participants take PepZinGI and a placebo each for one week, separated by a two-week washout period, totaling 29 days. During each treatment week, participants consume a hurdle meal designed to trigger heartburn. The study is fully remote with no in-person visits, and all activities are completed through the Alethios platform. Throughout the study, participants complete electronic surveys on heartburn severity and frequency and sleep quality at baseline, day 8, and day 29. Wearable devices track sleep duration, quality, resting heart rate, heart rate variability, and restlessness continuously from baseline through day 29. Participant satisfaction is also assessed with questionnaires after each treatment phase. Rescue medication use and timing of symptom relief are recorded, ensuring comprehensive monitoring of heartburn and related sleep outcomes.
CONDITIONS
Brief Title
A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3821 years
- Self-reported food-triggered heartburn with known trigger foods
- Experience heartburn at least once per week
- Willing to avoid over-the-counter or supplement heartburn treatments during the study (calcium-carbonate rescue allowed but must be logged and not used during hurdle-meal day/night)
- Able to complete electronic surveys and follow study procedures
- Have access to or willingness to use a compatible wearable device
You will not qualify if you...
- Clinician-diagnosed GERD, ulcerative colitis, Crohn's disease, or inflammatory bowel disease
- Taking prescribed drugs for heartburn or digestive conditions
- Heartburn less than once per week or daily throughout the month
- Average of more than 1 alcoholic drink per day during the study
- Recreational drug use during the study
- Known allergy to zinc, L-carnosine, or study ingredients
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 weeks
Participants take PepZinGI or placebo for 1 week and consume a hurdle meal, followed by a 2-week washout period. This cycle is then crossed over to the other treatment.
2 treatment periods each lasting 1 week with a 2-week washout in between; visits occur at baseline, Day 8, and Day 29
Duration - Baseline through Day 29
Participants wear sleep devices continuously to measure sleep duration, sleep quality, resting heart rate, heart rate variability, and awake/restlessness moments throughout the study.
Continuous wearable device monitoring
Trial Site Locations
Total: 1 location
1
Alethios, Inc
San Francisco, California, United States, 94104
Actively Recruiting
Research Team
E
Edward Dosz, Ph.D
Z
Zoe Benham, B.S
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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