跳至主要内容
临床试验/NCT03310034
NCT03310034终止不适用

The Effects of NAD+-Precursor Supplementation on Energy Metabolism in Physically Compromised Elderly

Maastricht University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
2
主要终点
Ex vivo mitochondrial respiration

研究概览

简要总结

This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Outcomes are related to mitochondrial function, energy metabolism, and physical function will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females
  • Age ≥ 65 ≤ 75 years;
  • BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
  • Normal physical activity levels: maximum of 1 hour per week engagement in a structured exercise session;
  • SPPB score 4-9 and (pre-)frail;
  • Subject should be in sufficient health to participate in the experiments, to be judged by the responsible physician based on the subject's medical history.

排除标准

  • Not meeting all inclusion criteria;
  • Excessive alcohol use and/or drug abuse;
  • Subjects with diabetes mellitus type 2;
  • Significant food allergies or intolerances concerning the study products;
  • Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
  • Medication use known to hamper subject's safety during the study procedures;
  • Subjects who use selective serotonin re-uptake inhibitors (SSRI), or selective norepinephrin re-uptake inhibitors (SNRI), or monoamino oxidase inhibitors (MAO-inhibitors), or clomipramine, or St. John's wort (Hypericum perforatum);
  • Subjects with contra-indications for MRI;
  • Subjects who do not want to be informed about unexpected medical findings;
  • Subjects who do not want that their treating physician to be informed;
  • Co-morbidities to which the intervention or program the may pose as a complicating factor;
  • Inability to participate and/or complete the required measurements.

结局指标

主要结局

Ex vivo mitochondrial respiration

时间窗: After 4 weeks of supplementation.

Ex vivo mitochondrial function in skeletal muscle measured by oxygen consumption in muscle fibres (muscle biopsy vastus lateralis) on lipid-derived and carbohydrate-derived substrates.

Basal metabolic rate

时间窗: After 4 weeks of supplementation.

Basal metabolic rate expressed as kcal/kg/min

In vivo mitochondrial capacity

时间窗: After 4 weeks of supplementation.

In vivo mitochondrial capacity measured with 31P-MRS.

Submaximal exercise energy expenditure

时间窗: After 4 weeks of supplementation.

Submaximal exercise energy expenditure expressed as kcal/kg/min

次要结局

  • Ectopic lipid accumulation(After 4 weeks of supplementation.)
  • Glucose tolerance(After 4 weeks of supplementation.)
  • Acetylcarnitine levels(After 4 weeks of supplementation.)
  • Physical function(After 4 weeks of supplementation.)

研究者

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

Patrick Schrauwen

Prof. Dr. P. Schrauwen

Maastricht University

研究点 (2)

Loading locations...

相似试验