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| Name | Class |
|---|---|
| Alethios, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PepZinGI | Dietary Supplement | 75 mg patented zinc-L-carnosine complex |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 8 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Day 29 |
| Sleep quality measured by wearable sleep devices |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alethios, Inc | San Francisco | California | 94104 | United States |
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| ID | Term |
|---|---|
| D006356 | Heartburn |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
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| Placebo |
| Dietary Supplement |
<0.1 mg zinc-L-carnosine |
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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. |
| 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. | 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. | 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. | 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. | Day 8 and Day 29 |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |