HeartburnNCT07379645
A Clinical Trial of PepZinGI® for Acute Heartburn Relief and Sleep Outcomes
A study testing PepZinGI in people with Heartburn, run by NutriScience Innovations, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heartburn
- What is being tested?
- PepZinGI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 11 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: PepZinGI® Crossover Heartburn Clinical Study
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.
- Conditions
- Heartburn
- Being tested
- PepZinGI, Placebo
- Keywords
- PepZinGI, heartburn, reflux, crossover, wearable sleep metrics
- Medical subject headings
- Heartburn, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PepZinGIDietary supplement
75 mg patented zinc-L-carnosine complex
PlaceboDietary supplement
<0.1 mg zinc-L-carnosine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: PepZinGI | Experimental | Participants will take PepZinGI for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period. Receives: Dietary Supplement: PepZinGI |
| Arm 2: Placebo | Experimental | Participants will take placebo for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a
Participant will select the frequency (Never, One Day, 2-6 days, Once a day, More than once a day) of heartburn related symptoms, if any. The data will be compared to baseline and day after hurdle meals for active and placebo. A lower frequency corresponds with a better outcome.
Measured: Baseline, Day 8, and Day 29
Participant sleep quality measured by Karolinska Sleep Scale
The validated 9-point scale will measure a participant's current level of sleepiness. The data will be compared to baseline and day after hurdle meal for active and placebo. The minimum value 1 denotes "extremely alert" whereas a 9 denotes "very sleepy". A lower score corresponds with a better outcome.
Measured: Baseline, Day 8, and Day 29
Heartburn severity measured by NutriScience Heartburn Questionnaire
Participants will rank severity of heartburn related symptoms (1: None, 2: A little bit, 3: Quite a bit, 4: A lot, 5: Extremely), if any. Participant data will be compared to PepZinGI and placebo supplementation. A lower value will correspond with a better outcome.
Measured: Day 8 and Day 29
Secondary outcomes (6)
Sleep duration measured by wearable sleep devices
Participant sleep duration in total hours and minutes will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Increased sleep duration will be considered a better outcome.
Measured: Baseline through Day 29
Sleep quality measured by wearable sleep devices
Participant sleep quality score will be acquired from wearable devices (Garmin, Apple Watch, WHOOP) with a range from 0 to 100. Data will be compared amongst study arms. Increased sleep quality score will be considered a better outcome.
Measured: Baseline through Day 29
Resting heart rate measured by wearable sleep devices
Participant resting heart rate in beats per minute will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Decreased resting heart rate will be considered a better outcome.
Measured: Baseline through Day 29
Heart rate variability measured by wearable sleep devices
Participant heart rate variability reflected as time between heartbeats in milliseconds will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Increased heart rate variability will be considered a better outcome.
Measured: Baseline through Day 29
Awake/restlessness moments measured by wearable sleep devices
Participant awake/restlessness measured through number of awakenings throughout total sleep duration will be acquired from wearable devices (Garmin, Apple Watch, WHOOP). Data will be compared amongst study arms. Decreased awake/restlessness will be considered a better outcome.
Measured: Baseline through Day 29
Participant satisfaction measured by phase completion questionnaires
Participant satisfaction and perceived effectiveness will be measured by product evaluation questions (taste, recommendation level, purchasing incentive) on a sliding scale from 1 to 10 with a higher number reflecting more positive views. Data from each question will be added to obtain a satisfaction score. Increased satisfaction scores will be considered a better outcome.
Measured: Day 8 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 Jan 2026
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NutriScience Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379645
- Sponsor's protocol ID
- NSCI01
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PepZinGI® Crossover Heartburn Clinical Study
- ClinicalTrials.gov ID
- NCT07379645
- Acronym / sponsor ID
- NSCI01
- Conditions
- Heartburn
- Keywords
- PepZinGI, heartburn, reflux, crossover, wearable sleep metrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NutriScience Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Alethios, Inc.
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: PepZinGI | Experimental | Dietary Supplement: PepZinGIParticipants will take PepZinGI for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period. |
| Arm 2: Placebo | Experimental | Dietary Supplement: PlaceboParticipants will take placebo for 1 week and consume a hurdle meal. This will be followed by a 2-week washout period. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PepZinGI75 mg patented zinc-L-carnosine complex | Dietary supplement | Arm 1: PepZinGI |
| Placebo<0.1 mg zinc-L-carnosine | Dietary supplement | Arm 2: Placebo |
Primary outcome
Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a
Time frame: Baseline, Day 8, and Day 29
Participant will select the frequency (Never, One Day, 2-6 days, Once a day, More than once a day) of heartburn related symptoms, if any. The data will be compared to baseline and day after hurdle meals for active and placebo. A lower frequency corresponds with a better outcome.
Participant sleep quality measured by Karolinska Sleep Scale
Time frame: Baseline, Day 8, and Day 29
The validated 9-point scale will measure a participant's current level of sleepiness. The data will be compared to baseline and day after hurdle meal for active and placebo. The minimum value 1 denotes "extremely alert" whereas a 9 denotes "very sleepy". A lower score corresponds with a better outcome.
Heartburn severity measured by NutriScience Heartburn Questionnaire
Time frame: Day 8 and Day 29
Participants will rank severity of heartburn related symptoms (1: None, 2: A little bit, 3: Quite a bit, 4: A lot, 5: Extremely), if any. Participant data will be compared to PepZinGI and placebo supplementation. A lower value will correspond with a better outcome.
6 secondary outcomes
Sleep duration measured by wearable sleep devices
Time frame: Baseline through Day 29
Sleep quality measured by wearable sleep devices
Time frame: Baseline through Day 29
Resting heart rate measured by wearable sleep devices
Time frame: Baseline through Day 29
Heart rate variability measured by wearable sleep devices
Time frame: Baseline through Day 29
Awake/restlessness moments measured by wearable sleep devices
Time frame: Baseline through Day 29
Participant satisfaction measured by phase completion questionnaires
Time frame: Day 8 and Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Heartburn
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Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
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RecruitingObservational study
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Enrolling by invitationObservational study
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PepZinGI in people with Heartburn, run by NutriScience Innovations, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a (time frame: Baseline, Day 8, and Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.