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

NutriScience Innovations, LLC

Status: Not yet enrolling

Conditions: Heartburn

Treatments: Dietary Supplement: Placebo; Dietary Supplement: PepZinGI

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07379645

NSCI01

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Arm 1: PepZinGI

Experimental group

Description:

Participants will take PepZinGI for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period.

Treatment:

Dietary Supplement: PepZinGI

Arm 2: Placebo

Experimental group

Description:

Participants will take placebo for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period.

Treatment:

Dietary Supplement: Placebo