Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR
研究概览
简要总结
Over-the-counter drugs like acetaminophen (e.g., Tylenol®) can be detrimental. In space, astronauts who have pain and constant discomfort use acetaminophen extensively. Investigators are studying the effects of acetaminophen under space-like conditions since acetaminophen might affect astronauts' health. Investigators also wish to see whether a dietary supplement can reduce some negative effects of acetaminophen.
It is believed that acetaminophen promotes the productions of chemicals in the body that could be toxic.
In this study, measurements of these chemicals in urine after ingestion of 1 tablet of acetaminophen and compare these measurements to when acetaminophen is taken at the same time as a dietary supplement. This study will also explore whether these products are more abundant when blood is placed under conditions that mimic space. Therefore, this study will collect blood from a few volunteers who took acetaminophen, and acetaminophen with the dietary supplement.
详细描述
In space, astronauts are constantly exposed to conditions the body is not used to. To relieve pain and discomfort, astronauts often use acetaminophen. This study investigates a possible negative synergistic effect between using acetaminophen and space-like stressors as they both generate oxidative stress and produce toxins that distribute around the body and disrupt cellular function in other tissues. The study seeks to examine whether a dietary supplement, nicotinamide riboside (NR), can reduce some adverse effects of these toxins by reducing their production when taking acetaminophen.
The study will measure these materials in urine after ingestion of 1 gram of acetaminophen and compare these measurements to when the same amount of acetaminophen is taken at the same time as NR. It will also evaluate whether these toxins are more abundant when blood is placed under conditions resembling space. Therefore, blood collection from a few volunteers who take acetaminophen, and acetaminophen with NR. Ultimately, this work will establish whether NR could reduce the generation of specific endotoxins.
For this study, male and female volunteers are needed to donate urine for testing the effect of 1000mg dose of Tylenol® and one 1000mg dose of Tylenol® with one 250mg dose of Nicotinamide Riboside on the abundance of uremic toxins in urine and in blood. Volunteers are also needed to donate blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
Sample will be assigned a unique identifier to de-identify samples from the study team. This unique identifier will be assigned by the clinical manager, who will be providing the informed consent. Each sample will be labeled to include gender, race and ethnicity.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Individual allergic to acetaminophen or nicotinamide riboside
研究组 & 干预措施
Tylenol and Nicotinamide Riboside
干预措施: Acetaminophen (Drug)
Tylenol and Nicotinamide Riboside
干预措施: Acetaminophen and Nicotinamide Riboside (Combination Product)
Tylenol Only
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR
时间窗: At consent and 6 hours post dose
Multiple blood draws pre and post dose of acetaminophen plus NR
Count the DNA damage occurring upon space-like stressors following exposure to acetaminophen, with and without NR
时间窗: At consent and 6 hours post dose
Multiple blood draws pre and post dose of acetaminophen with or without NR.
Count the quantity of ox-NAD(P) present with exposure to acetaminophen, with and without NR
时间窗: At consent and 6 hours post dose
Multiple blood draws pre and post dose of acetaminophen plus NR
Count the quantity of PYR-ribosides present with exposure to acetaminophen, with and without NR
时间窗: Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
A urine sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR
Count the quantity of PYR-nucleotides present with exposure to acetaminophen, with and without NR
时间窗: Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
A blood sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR
次要结局
未报告次要终点
研究者
Marie Migaud
Professor of Pharmacology
University of South Alabama