NCT04905446已完成不适用
Measurement of NAD+ Synthesis in Human Skeletal Muscle
AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年9月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS)
研究概览
简要总结
The key objective of this pilot research study is to dose human volunteers with a heavy (non-radioactive) isotope derivative of nicotinamide to detect NAD synthesis in human skeletal muscle. The ultimate goal is to examine the impact of lifestyle choices, aging, nutraceuticals, and drugs on the rate of NAD synthesis in human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects who, at the time of screening are between the ages of 21 to 40 years of age, inclusive.
- •BMI between 20-30 kg/m2 at the screening visit (SV)
- •Understands the procedures and agrees to participate by giving written informed consent
- •Willing and able to comply with the scheduled study day and other study procedures
排除标准
- •Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:
- •History of type 1 or type 2 diabetes mellitus, including pre-diabetes (HbA1c > 5.7)
- •History of any antihyperglycemic agent (e.g., insulin)
- •Currently taking medications that can alter glucose homeostasis (e.g., steroids, glucocorticoids, nicotinic acid) or skeletal muscle metabolism
- •History of taking Tru Niagen, Basis (or any other NR-containing NAD+ booster) or niacin supplements.
- •Any bleeding disorders
- •Currently taking any aspirin (ASA) (including baby ASA) or NSAIDs (ibuprofen, naproxen, etc.) that cannot be safely stopped throughout the study. There is a recommended hold on NSAIDs and/or ASA for at least 2 days prior to biopsy, although not exclusionary
- •Presence of bruising in lower extremities
- •Any major surgery within the past 3 months
- •Any acute or chronic infections
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological or allergic diseases, but excluding untreated, asymptomatic, seasonal allergies at the time of intervention.
- •Previous difficulty with lidocaine or other local anesthetic agents
- •Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
- •Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
- •Use of tobacco or nicotine-containing products within the last 12 months.
- •Chronic kidney disease with GFR of < 60
- •Anemia (hemoglobin <12 g/dl) during screening
- •History of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- •Liver function testing for ALT or AST greater than or equal to 2 times the upper limit of normal
- •Participation in studies involving investigational drug(s) within 30 days prior to Screening visit
- •Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening (participants may not donate blood any time during the study, through the final study day)
- •Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days Labs may be repeated at the discretion of the PI, MI or Sub-investigators (Sub-I).
研究组 & 干预措施
Healthy male subjects
Other
干预措施: Deuterated nicotinamide (D4-NAM) IV infusion (Other)
Healthy male subjects
Other
干预措施: Skeletal muscle biopsy (Procedure)
Healthy male subjects
Other
干预措施: Skin tissue biopsy (Procedure)
结局指标
主要结局
Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS)
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Research Study of a New Medicine NNC0113-6856 in Healthy MalesHealthy VolunteersType 2 DiabetesNCT05521256Novo Nordisk A/S70
已完成
早期 1 期
Effect of Sublingually Generated S-nitroso-N-acetylcysteine on Systemic Blood Pressure.Cardiovascular DiseasesHypertensionNCT05798481University of Alabama at Birmingham14
已完成
1 期
NOX-A12 First-in-human (FIH) StudyAutologous Stem Cell TransplantationNCT00976378TME Pharma AG48
已完成
1 期
Safety and Pharmacodynamic Study of CD-NPHeart Failure, CongestiveNCT00482937Nile Therapeutics22
已完成
不适用
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical FusionDegenerative Disc DiseaseNCT01495234Medtronic Spinal and Biologics15