PepZinGI® Crossover Heartburn Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PepZinGI (Dietary Supplement)
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.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Heartburn frequency measured by PROMIS-Gastroesophageal Reflux 13a
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Sleep duration measured by wearable sleep devices(Baseline through Day 29)
- Sleep quality measured by wearable sleep devices(Baseline through Day 29)
- Resting heart rate measured by wearable sleep devices(Baseline through Day 29)
- Heart rate variability measured by wearable sleep devices(Baseline through Day 29)
- Awake/restlessness moments measured by wearable sleep devices(Baseline through Day 29)
- Participant satisfaction measured by phase completion questionnaires(Day 8 and Day 29)