PepZinGI® for quick relief of food-triggered heartburn and better sleep.
PepZinGI® Crossover Heartburn Clinical Study
This remote study will try PepZinGI® to see if it reduces food-triggered heartburn and improves sleep in adults who have heartburn at least once a week.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | NutriScience Innovations, LLC Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07379645 on ClinicalTrials.gov |
What this trial studies
This decentralized, randomized, double-blind, placebo-controlled, two-period crossover study will enroll about 50 adults and compare one week of PepZinGI® with one week of placebo separated by a two-week washout. Participants complete two 1-week treatment periods and report heartburn severity and frequency using the NutriScience Heartburn Questionnaire as the primary outcome. Secondary outcomes include PROMIS GI Reflux-13a, time to relief, use of rescue calcium carbonate, wearable-derived sleep metrics, Karolinska Sleep Scale, sleep diary entries, and participant satisfaction. All procedures and data collection are conducted remotely through Alethios and participants must be able to complete electronic surveys and use a compatible wearable device.
Who should consider this trial
Good fit: Adults aged 21 and older with self-reported food-triggered heartburn at least once per week who can avoid OTC heartburn products during the study and use a compatible wearable are ideal candidates.
Not a fit: People with clinician-diagnosed GERD or inflammatory bowel disease, those taking prescription heartburn medications, pregnant or breastfeeding people, and those with daily chronic heartburn are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, PepZinGI® could reduce the severity and frequency of food-triggered heartburn and improve sleep after meals.
How similar studies have performed: Using zinc-L-carnosine for acute heartburn relief is relatively novel; small prior studies suggest mucosal protective effects but there is limited direct evidence for rapid symptom relief.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- Alethios, Inc — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Edward Dosz, Ph.D
- Email: edosz@nutriscienceusa.com
- Phone: (203) 372-8877
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.