Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity

NCT06425042 | Recruiting DMC

• 1 other identifier: 23-041
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging; Lifestyle-related Condition; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle mitochondrial respiratory capacity

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

  12 weeks

Secondary Outcomes (14)

• 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

Study Arms (2)

NR+EXTR

EXPERIMENTAL

This arm will ingest NR orally and perform exercise training

Dietary Supplement: Nicotinamide Riboside (NR)

PLA+EXTR

PLACEBO COMPARATOR

This arm will ingest placebo orally and perform exercise training

Dietary Supplement: Placebo

Interventions

Nicotinamide Riboside (NR) DIETARY_SUPPLEMENT

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

NR+EXTR

Placebo DIETARY_SUPPLEMENT

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

PLA+EXTR

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Finis Terrae University: lead

Study Sites (1)

Finis Terrae University

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Metabolic Diseases

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Rodrigo Mancilla, PhD

CONTACT

+56953676588; rmancilla@uft.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, PhD

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 22, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)