The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio
研究概览
简要总结
The primary aim of this study is to investigate the effects of exogenously administered nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging.
The secondary aims are to investigate the change in brain PCr/ATP and creatine kinase enzyme rate after NR use. In addition, NAD+/NADH ratio, PCr/ATP and CK enzyme rate will be measured in the calf muscle, as secondary outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-80 year-old
- •Male or female
- •Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID))
- •Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only.
排除标准
- •Significant medical or neurological illness.
- •Diagnosis diabetes mellitus (DM), uncontrolled hypertension (HTN), severe hypotension, coronary artery disease (CAD), metabolic syndrome, glaucoma, liver impairment, decreased renal function, respiratory disorders, uncontrolled peptic ulcer disease.
- •Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women
- •Pregnancy. Females of child-bearing age must be using an effective contraceptive method.
- •History of smoking, substance abuse or dependence.
- •Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal- containing intrauterine devices)
- •Medical condition that would prevent blood draws, including current anti-coagulant or anti-aggregant therapy, tendency for abnormal scarring (e.g. keloids).
- •Difficulty in swallowing capsules.
研究组 & 干预措施
Nicotinamide riboside 2g/day
Participants will receive NR at a dose of 2g/day
干预措施: Nicotinamide Riboside (Drug)
结局指标
主要结局
Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio
时间窗: Baseline and after 15 days of supplement use
Change from baseline to the end of treatment in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy The NAD+/NADH ratio is calculated by first quantifying NAD+ and NADH separately in the data and then obtaining a simple ratio. There is a normative NAD+/NADH ratio range in healthy brain and deviations from this level in either direction can be a sign of pathology.
次要结局
- Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)(Baseline and after 15 days of supplement use)
- Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate(Baseline and after 15 days of supplement use)
- Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)(Baseline and after 15 days of supplement use)
- Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate(Baseline and after 15 days of supplement use)
- Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio(Baseline and after 15 days of supplement use)
研究者
Dost Ongur
Chief of Psychotic Disorders Division at McLean Hospital and Associate Professor in Psychiatry at Harvard Medical School
Mclean Hospital