NCT04910061已完成不适用
A Single-centre Trial to Investigate the Safety and Pharmacokinetics of Orally Administered Nicotinamide Mononucleotide (NMN, 400mg) Over 29 Days of Supplementation in Healthy Adults.
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
- 24
- 试验地点
- 2
- 主要终点
- Safety as measured by subject incident of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to investigate the safety, pharmacokinetic profile, and effects of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects will be studied over the course of 30 days in a repeated-dose study through the collection of blood and urine samples, and administration of surveys and questionnaires.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Naturally post-menopausal women with amenorrhea for 1 year will be eligible.
- •Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using an acceptable methods of birth control.
- •BMI between 18.5 and 29.9 kg/m2; with a stable weight over the last 3 months (±2 kg).
- •Having given written informed consent to participate in the research trial.
- •Agrees to maintain current dietary habits and level of physical activity for the trial duration, except as directed by the Nutritionist Agrees to follow dietary guidelines, consume standardized meals, and abide by dietary guidelines for dinner prior to specified visits (as outlined by Nutritionist at screening)
排除标准
- •Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
- •Active infection, or history of infection and/or antibiotic use 2 weeks prior to the screening visit as assessed by Investigator.
- •Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.
- •Have a history of, or present with, cardiovascular, renal, hepatic, endocrine, gastrointestinal, or inflammatory disease, as assessed by Investigator.
- •Has consumed multivitamins or supplements (such as St. John's Wort) within 1 month prior to the study, or unwilling to discontinue use for the duration of the study
- •History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator.
- •Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by Investigator.
- •Presenting with immune suppression (e.g. autoimmune disease, HIV), as assessed by Investigator.
- •Has undergone surgery in the last 3 months, or has surgery planned during the trial period, as assessed by Investigator.
- •Uses concomitant medications including natural health products (excluding contraceptives and PRN or other medications, which in the Investigator's opinion, do not affect the trial outcomes or participant safety).
- •Currently following a regimented or restricted diet which in the opinion of the Nutritionist and/or PI would negatively affect the study outcome or participants' ability to comply with study requirements, or has in the 3 months prior to enrollment.
- •Plans to change dietary habits and/or activity level during the trial period.
- •Frequent consumption of alcohol (> 2 standard servings of alcohol/day on average).
- •History of (assessed by PI) or current tobacco use (verified by positive cotinine urinalysis)
- •Positive urinalysis for drugs of abuse (amphetamines, Cannabinoids, Cocaine and Opiates)
- •Presenting a niacin deficiency, as assessed by Nutritionist's dietary assessment at screening, and Investigator's physical examination.
- •Has difficulty swallowing capsules.
- •Inability to provide blood and/or urine samples.
- •Positive pregnancy test, intent to get pregnant, or breastfeeding.
- •Any other condition that, in the opinion of the Investigator, could impair the Investigator's ability to complete the study outcomes and participant safety. Participating simultaneously in another clinical research protocol or having participated in another research study for which the exclusion period would not be completed
结局指标
主要结局
Safety as measured by subject incident of treatment-emergent adverse events
时间窗: between Day 1 and Day 30
Subject incidence of treatment-emergent adverse events
Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.
时间窗: between Day 1 and Day 30
Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete blood count, C reactive protein, AST, ALT, bilirubin, GGT, Alkaline phosphatase, creatinine, creatine kinase, Sodium, Potassium, Chloride)
Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs
时间窗: between Day 1 and Day 30
Subject incidence of treatment-emergent clinically significant changes in vital signs (body temperature, heart rate and blood pressure)
次要结局
- Change from baseline in NAD+ metabolites concentrations in plasma(Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29)
- Change from baseline in homocysteine concentrations(Day 1, Day 29)
- Changes in body weight(Day 1, Day 29)
- Changes in Fatigue state(Day 1, Day 29)
- Change in blood lipid profile from baseline during the intervention period(Day 1, Day 29)
- Changes in Sleep quality(Day 1, Day 29)
- Change from baseline in NAD+ metabolites concentrations in urine(Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29)
- Change in blood glucose (fasting) from baseline during the intervention period(Day 1, Day 29)
- Change from baseline in NAD+ and NMN concentrations in whole blood(Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29)
- Tolerance(Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30)
- Changes in Quality of life(Day 1, Day 29)
研究者
研究点 (2)
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