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

Part of paid clinical trials in San Francisco, California.

Sponsor
NutriScience Innovations, LLC
Study ID
NCT07379645
Status
Recruiting
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Conditions

  • Heartburn

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PepZinGI — DIETARY_SUPPLEMENT
    75 mg patented zinc-L-carnosine complex
  • Placebo — DIETARY_SUPPLEMENT
    \<0.1 mg zinc-L-carnosine

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Apr 2026
Primary completion
May 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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.
  • 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.

Primary Outcome Measure

Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a [ Time Frame: Baseline, Day 8, and Day 29 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Alethios, IncSan FranciscoCalifornia94104
Zoe Benham, B.S.
[email protected]
(650) 206-8006
Edward Dosz, Ph.D.
[email protected]
(203) 372-8877
Edward Dosz, Ph.D. (PRINCIPAL_INVESTIGATOR)

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Alethios, Inc· San Francisco, CA

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