NCT04862338已完成不适用
Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Seneque SA
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change from baseline in NAD+ concentrations in whole blood
研究概览
简要总结
The purpose of this study is to evaluate the physiological and/or biological actions of nicotinamide mononucleotide (NMN-C) in healthy adults receiving a repeated-dose over the course of 28 days by studying the tolerance and pharmacodynamics of this product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers should be
- •Men between the ages of 30 and 60 years old
- •With a BMI between 23 and 30 kg/m2
- •With a weight > or = 70kg
- •Giving their free informed consent to the study
排除标准
- •May not be included in the study Volunteers with
- •a history of allergy to vitamin B3 (niacin or nicotinamide)
- •immunocompromised or suffering from a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic or infectious)
- •with abnormal results on the screening bioassay (CBC, Transaminases (AST, ALT, GGT), Bilirubin, Creatinine, CPK, Ionogram, Blood glucose, Hba1c, Lipid profile)
- •having donated blood in the month preceding inclusion,
- •having consumed more than 2 glasses of alcohol per day,
- •being under medication or taking food supplements,
- •having reached the maximum compensation threshold for research involving the human being as provided for by the regulations or having participated in another biomedical research project that required blood samples in the previous month,
- •involved in another clinical trial or being in the exclusion period of a previous clinical trial.
结局指标
主要结局
Change from baseline in NAD+ concentrations in whole blood
时间窗: Day 0, Day 14 and Day 28
次要结局
- Change from baseline in NMN concentrations in whole blood(Day 0, Day 14 and Day 28)
- Evolution of blood lipid levels(Day -7, Day 14 and Day 28)
- Evolution of Blood cell count(Day -7, Day 14 and Day 28)
- Evolution of Heart rate(Day -7 and Day 28)
- Evolution of the mitochondrial DNA ratio(Day 0 and Day 28)
- Evolution of blood glucose levels(Day -7, Day 14 and Day 28)
- Evolution of Creatinine levels in blood(Day -7, Day 14 and Day 28)
- Creatine phosphokinase (CPK) levels in blood(Day -7, Day 14 and Day 28)
- Evolution of blood Ionogram(Day -7, Day 14 and Day 28)
- Evolution of Diastolic blood pressure(Day -7 and Day 28)
- Evolution of Bilirubin levels in blood(Day -7, Day 14 and Day 28)
- Change from baseline NAD+ metabolite concentrations in plasma(Day 0, Day 14 and Day 28)
- Change from baseline NAD+ metabolite concentrations in urine(Day -7, Day 14 and Day 28)
- Adverse events(Day 14 and Day 28)
- Evolution of Transaminases (ASAT, ALAT, GGT) levels in blood(Day -7, Day 14 and Day 28)
- Evolution of Systolic blood pressure(Day -7 and Day 28)
- Evolution of body composition(Day -7, Day 14 and Day 28)
- Evolution of weight(Day -7, Day 14 and Day 28)
研究者
研究点 (2)
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