Clinical trial NCT06425042: Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity
Official title: Boosting the NAD+ Levels in Older Individuals Via Nicotinamide Riboside Supplementation and Exercise Training to Promote Metabolic Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Lifestyle-related Condition
Metabolic Diseases
Lead sponsor: Finis Terrae University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Smoking
* 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)

Primary outcomes:
measure: Skeletal muscle mitochondrial respiratory capacity
timeFrame: 12 weeks
measure: Skeletal muscle mitochondrial content
timeFrame: 12 weeks
Secondary outcomes:
measure: Quantification of proteins that regulate oxidative metabolism
timeFrame: 12 weeks
measure: Maximal aerobic capacity
timeFrame: 12 weeks
measure: Walking speed and distance
timeFrame: 12 weeks
measure: Seating and standing transitions
timeFrame: 12 weeks
measure: Exercise efficiency
timeFrame: 12 weeks
measure: Intrahepatic liver fat content
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Total muscle mass
timeFrame: 12 weeks
measure: Total fat mass
timeFrame: 12 weeks
measure: Fat-free mass
timeFrame: 12 weeks
measure: NAD+ levels
timeFrame: 12 weeks
measure: 24h Blood pressure
timeFrame: 12 weeks
measure: Heart rate variability
timeFrame: 12 weeks
measure: Resting energy expenditure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Finis Terrae University
state: Region Metropolitana
Study officials:
References: