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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: PepZinGI 		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
    75 mg patented zinc-L-carnosine complex
Experimental
Arm 2: Placebo 		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
    <0.1 mg zinc-L-carnosine

Recruiting Locations

Alethios, Inc
San Francisco, California 94104
Contact:
Zoe Benham, B.S.
(650) 206-8006
support@alethios.com

More Details

Status
Recruiting
Sponsor
NutriScience Innovations, LLC

Study Contact

Edward Dosz, Ph.D
(203) 372-8877
edosz@nutriscienceusa.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.