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临床试验/NCT05561712
NCT05561712已完成不适用

Method Optimization for the Quantification of the NAD (Nicotinamide Adenine Dinucleotide) Metabolome in Human Whole Blood, Plasma, and Urine, and Evaluation of Baseline Inter and Intra-subject Variability

Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Comparison of NAD metabolite concentrations in whole blood, collected with different tubes and anticoagulants.

研究概览

简要总结

Method optimization for the quantification of the NAD metabolome in human whole blood, and evaluation of baseline inter and intra-subject variability.

详细描述

Whole blood from healthy participants will be collected to optimize analytical method based on liquid chromatography tandem mass spectrometry (LC-MS/MS) for the analysis of the NAD metabolome in biological samples. Parameters such as collection volume and anti-coagulants will be investigated for optimal quantification. Moreover, inter- and intra-subject variability of NAD metabolite levels in whole blood will be evaluated. Plasma and urine will also collected for method development and variability measurements.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women (based on anamnesis),
  • Age between 18 and 55 years,
  • Body Mass Index (BMI) = weight (kg) / height (m)2 between 18.5 to 28 kg/m2.

排除标准

  • Pregnant or lactating women
  • Sick or with a strong cold
  • With vitamin B3 supplementations or under low carbohydrate of ketogenic diet
  • Under prescribed chronic medication, except contraceptive pill.

结局指标

主要结局

Comparison of NAD metabolite concentrations in whole blood, collected with different tubes and anticoagulants.

时间窗: through study completion, an average of 1 year

NAD metabolites in whole blood will be quantified by liquid chromatography-tandem

次要结局

  • Validation of the method for a set of NAD metabolites in plasma and urine (including determination of Limit Of Detection-LOD, Limit Of Quantification- LOQ).(through study completion, an average of 1 year)
  • Estimation of inter- and intra-subject variabilities of NAD metabolites in whole blood(through study completion, an average of 1 year)

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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