跳至主要内容
临床试验/NCT06425042
NCT06425042招募中不适用

Boosting the NAD+ Levels in Older Individuals Via Nicotinamide Riboside Supplementation and Exercise Training to Promote Metabolic Health

Finis Terrae University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
28
试验地点
1
主要终点
Skeletal muscle mitochondrial respiratory capacity

研究概览

简要总结

The prevalence of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is mounting worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with diminished skeletal muscle mitochondrial function in humans. Nicotinamide adenosine dinucleotide (NAD) is a coenzyme that regulates mitochondrial function, therefore, plays an important role in energy metabolism. Importantly, it has been shown that high cellular NAD+ levels as well as a high NAD+/NADH ratio promote metabolic and mitochondrial health. In contrast, NAD+ bioavailability declines upon aging in humans as well as in animal models of metabolic disorders and type 2 diabetes. These findings fuel the notion of boosting the NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in aged individuals. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, boosts cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Interestingly, Recently, it has been suggested that metabolic conditions where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This metabolic condition could be achieved by exercise. However, studies combining NR and exercise are lacking, and that is why we will perform the present study.

研究设计

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

盲法说明

Double blinded

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants are able to provide signed and dated written informed consent prior to any study specific procedures
  • Aged ≥ 60 and ≤ 80 years
  • Body mass index (BMI) 25 - 35 kg/m2
  • Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
  • No signs of active cardiovascular disease, liver or kidney malfunction

排除标准

  • Patients with congestive heart failure and and/or severe renal and or liver insufficiency
  • Uncontrolled hypertension
  • Any contra-indication for MRI scanning
  • Alcohol consumption of > 3 servings per day for man and >2 servings per day for woman
  • Unstable body weight (weight gain or loss > 5kg in the last 3 months)
  • Engagement in structured exercise activities > 2 hours a week
  • Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results
  • Use of food supplements containing NR or Resveratrol (similar working mechanisms)

结局指标

主要结局

Skeletal muscle mitochondrial respiratory capacity

时间窗: 12 weeks

Skeletal muscle mitochondrial respiratory capacity will be measured in permeabilized fibres.

Skeletal muscle mitochondrial respiratory capacity

时间窗: 12 weeks

Skeletal muscle mitochondrial respiratory capacity will be measured in permeabilized fibres.

次要结局

  • Quantification of proteins that regulate oxidative metabolism(12 weeks)
  • Skeletal muscle mitochondrial content(12 weeks)
  • Maximal aerobic capacity(12 weeks)
  • Walking speed and distance(12 weeks)
  • Seating and standing transitions(12 weeks)
  • Exercise efficiency(12 weeks)
  • Intrahepatic liver fat content(12 weeks)
  • Body weight(12 weeks)
  • Total muscle mass(12 weeks)
  • Total fat mass(12 weeks)
  • Fat-free mass(12 weeks)
  • NAD+ levels(12 weeks)
  • 24h Blood pressure(12 weeks)
  • Resting energy expenditure(12 weeks)
  • Maximal aerobic capacity(12 weeks)
  • Walking speed and distance(12 weeks)
  • Seating and standing transitions(12 weeks)
  • Exercise efficiency(12 weeks)
  • Body weight(12 weeks)
  • Total muscle mass(12 weeks)
  • Total fat mass(12 weeks)
  • Fat-free mass(12 weeks)
  • NAD+ levels(12 weeks)
  • 24h Blood pressure(12 weeks)
  • Resting energy expenditure(12 weeks)

研究者

发起方
Finis Terrae University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Mancilla

Doctor, PhD

Finis Terrae University

研究点 (1)

Loading locations...

相似试验