Actively Recruiting
A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes
Led by NutriScience Innovations, LLC · Updated on 2026-04-13
50
Participants Needed
1
Research Sites
23 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
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
Official Title
A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 61 years
- Self-reported food-triggered heartburn with known trigger foods
- Heartburn at least once per week
- Willing to avoid OTC or supplement heartburn treatments during the study (except calcium-carbonate rescue, which must be logged and not used during hurdle-meal day/night)
- Able to complete electronic surveys and follow study procedures
- 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 other inflammatory bowel diseases
- Use of prescribed drugs for heartburn or digestive conditions
- Heartburn occurring less than once per week or daily throughout the month
- More than 1 alcoholic drink per day on average 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
Trial Site Locations
Total: 1 location
1
Alethios, Inc
San Francisco, California, United States, 94104
Actively Recruiting
Research Team
E
Edward Dosz, Ph.D
CONTACT
Z
Zoe Benham, B.S
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here