A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes

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

  • Heartburn

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