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临床试验/NCT06005350
NCT06005350进行中(未招募)不适用

Validation of an Enzymatic Assay for Quantification of Nicotinamide Adenine Dinucleotide in Blood Plasma After Ingestion of the Vitamin B3 Variant Nicotinamide Riboside: a Randomized Controlled Trial

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
54
试验地点
2
主要终点
NR increases plasma concentrations of eNAD+

研究概览

简要总结

The investigation is a clinical study in which the impact of taking the dietary supplement nicotinamide riboside (NR) on the concentration of extracellular nicotinamide adenine dinucleotide (eNAD+) in human plasma over time will be determined. The study will be conducted in a randomized, double-blinded, and placebo-controlled manner.

详细描述

The significance of nicotinamide adenine dinucleotide (NAD+) in promoting a healthy life is currently under intense research. Despite an increasing number of research groups focusing on NAD+, there is no validated measurement method for extracellular NAD+. With this research project, the investigators aim to address this research gap.

The coenzyme NAD+ is one of the central regulators of metabolism, existing mostly in its oxidized form, NAD+, and its reduced form, NADH, in a dynamic equilibrium. NAD+ is indispensable for various metabolic processes, and is especially key in ATP generation. It also enables gluconeogenesis, ketogenesis, pentose phosphate production, heme and lipid synthesis, and the elimination of oxygen radicals.

To validate the NAD+ assay as a robust and reliable quantification method of extracellular NAD+, a controlled increase of the measured metabolite in blood plasma is required through NAD+ precursor administration.

Multiple studies have already demonstrated that oral NR intake can increase NAD+ levels in mammalian cells, rodent tissues, and peripheral blood mononuclear cells (PBMCs) in humans. However, this relationship has not been explored in the extracellular space due to the lack of reliable quantification of eNAD+ levels. Now, using the NAD+ assay, the investigators aim to examine the increase of eNAD+ after oral NR intake and provide initial data on the effects of a 1000 mg/day dosage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Good general health
  • Normal nutritional status and
  • Age >18 years.

排除标准

  • Pregnancy and/or lactation, or
  • Severe psychiatric disorders, or
  • Conditions that involve attention deficits, or
  • Severe medical conditions, or
  • Withdrawal of consent by the participant.

结局指标

主要结局

NR increases plasma concentrations of eNAD+

时间窗: 10 days

The daily intake of 1,000 mg of NR changes the concentration of eNAD+ over the course of 10 days. The NAD+ assay measures the changes in concentrations of eNAD+ in plasma.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felix Krenzien

Principal Investigator

Charite University, Berlin, Germany

研究点 (2)

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