Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity (RESTORENAD)

Finis Terrae University

Status: Enrolling

Conditions: Metabolic Diseases; Healthy Aging; Lifestyle-related Condition

Treatments: Dietary Supplement: Nicotinamide Riboside (NR); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06425042

23-041

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

NR+EXTR

Experimental group

Description:

This arm will ingest NR orally and perform exercise training

Treatment:

Dietary Supplement: Nicotinamide Riboside (NR)

PLA+EXTR

Placebo Comparator group

Description:

This arm will ingest placebo orally and perform exercise training

Treatment:

Dietary Supplement: Placebo