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NCT Number: NCT06425042

Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity

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.

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Key information

Conditions

Healthy Aging Lifestyle-related Condition Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Finis Terrae University

Santiago, Santiago Metropolitan, Chile

Location status: Recruiting

Location contact

Rodrigo Mancilla, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nicotinamide Riboside (NR)

Dietary Supplement

Participants will ingest 1g/d of NR orally during 12 weeks in parallel to a exercise training program

Placebo

Dietary Supplement

Participants will ingest 1g/d of placebo orally during 12 weeks in parallel to a exercise training program

Primary outcomes

  1. Skeletal muscle mitochondrial respiratory capacity

    Time frame: 12 weeks

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

Secondary outcomes

  1. Quantification of proteins that regulate oxidative metabolism

    Time frame: 12 weeks

    Quantification of proteins content of oxidative phosphorylation system in muscle biopsies

  2. Skeletal muscle mitochondrial content

    Time frame: 12 weeks

    Proteins content of oxidative phosphorylation system will be quantified from muscle biopsy

  3. Maximal aerobic capacity

    Time frame: 12 weeks

    Maximal aerobic capacity will be measure upon a progressive cycling test

  4. Walking speed and distance

    Time frame: 12 weeks

    Walking speed and distance will be measured via the 6-minutes walking test

  5. Seating and standing transitions

    Time frame: 12 weeks

    Time spent on performing seating and standing transitions will be measured upon the timed-up and go test

  6. Exercise efficiency

    Time frame: 12 weeks

    Exercise efficiency will be measured upon a sub maximal cycling test and indirect calorimetry

  7. Intrahepatic liver fat content

    Time frame: 12 weeks

    Intrahepatic liver fat content will be measured by 1H-MRS

  8. Body weight

    Time frame: 12 weeks

    body weight will be measured in kilograms

  9. Total muscle mass

    Time frame: 12 weeks

    total muscle mass will be measured in kilograms and/or percentage

  10. Total fat mass

    Time frame: 12 weeks

    Total fat mass will be measured in kilograms and/or percentage

  11. Fat-free mass

    Time frame: 12 weeks

    Fat-free mass will be measured in kilograms and/or percentage

  12. NAD+ levels

    Time frame: 12 weeks

    NAD+ levels in circulation and in skeletal muscle

  13. 24h Blood pressure

    Time frame: 12 weeks

    24h Blood pressure will be measured with a continuous blood pressure holder device

  14. Resting energy expenditure

    Time frame: 12 weeks

    Resting energy expenditure will be measured by indirect calorimetry

Study contacts

Contact information is provided by the study sponsor or research team.

Rodrigo Mancilla, PhD

CONTACT

[email protected]

+56953676588

Sponsors and collaborators

Lead sponsor

Finis Terrae University

Other

Registry information

Official study title

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

Acronym: RESTORENAD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 22, 2024
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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