Healthy AgingRESTORENADNCT06425042
Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity
A study testing Nicotinamide Riboside (NR) in people with Healthy Aging and Lifestyle-related Condition, run by Finis Terrae University at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Lifestyle-related Condition, Metabolic Diseases
- What is being tested?
- Nicotinamide Riboside (NR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Finis Terrae University
Santiago, Santiago Metropolitan
Rodrigo Mancilla, PhD
About this study
Official title: Boosting the NAD+ Levels in Older Individuals Via Nicotinamide Riboside Supplementation and Exercise Training to Promote Metabolic Health
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.
- Being tested
- Nicotinamide Riboside (NR), Placebo
- Medical subject headings
- Mental Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide Riboside (NR)Dietary supplement
Participants will ingest 1g/d of NR orally during 12 weeks in parallel to a exercise training program
PlaceboDietary supplement
Participants will ingest 1g/d of placebo orally during 12 weeks in parallel to a exercise training program
| Study group | Role | What they receive |
|---|---|---|
| NR+EXTR | Experimental | This arm will ingest NR orally and perform exercise training Receives: Dietary Supplement: Nicotinamide Riboside (NR) |
| PLA+EXTR | Placebo comparator | This arm will ingest placebo orally and perform exercise training Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle mitochondrial respiratory capacity
Skeletal muscle mitochondrial respiratory capacity will be measured in permeabilized fibres.
Measured: 12 weeks
Secondary outcomes (14)
Quantification of proteins that regulate oxidative metabolism
Quantification of proteins content of oxidative phosphorylation system in muscle biopsies
Measured: 12 weeks
Skeletal muscle mitochondrial content
Proteins content of oxidative phosphorylation system will be quantified from muscle biopsy
Measured: 12 weeks
Maximal aerobic capacity
Maximal aerobic capacity will be measure upon a progressive cycling test
Measured: 12 weeks
Walking speed and distance
Walking speed and distance will be measured via the 6-minutes walking test
Measured: 12 weeks
Seating and standing transitions
Time spent on performing seating and standing transitions will be measured upon the timed-up and go test
Measured: 12 weeks
Exercise efficiency
Exercise efficiency will be measured upon a sub maximal cycling test and indirect calorimetry
Measured: 12 weeks
Intrahepatic liver fat content
Intrahepatic liver fat content will be measured by 1H-MRS
Measured: 12 weeks
Body weight
body weight will be measured in kilograms
Measured: 12 weeks
Total muscle mass
total muscle mass will be measured in kilograms and/or percentage
Measured: 12 weeks
Total fat mass
Total fat mass will be measured in kilograms and/or percentage
Measured: 12 weeks
Fat-free mass
Fat-free mass will be measured in kilograms and/or percentage
Measured: 12 weeks
NAD+ levels
NAD+ levels in circulation and in skeletal muscle
Measured: 12 weeks
24h Blood pressure
24h Blood pressure will be measured with a continuous blood pressure holder device
Measured: 12 weeks
Resting energy expenditure
Resting energy expenditure will be measured by indirect calorimetry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Mar 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finis Terrae University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Mancilla, Finis Terrae University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425042
- Sponsor's protocol ID
- 23-041
- Acronym
- RESTORENAD
- Status last verified
- Jul 2025
- First submitted
- 14 May 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting the NAD+ Levels in Older Individuals Via Nicotinamide Riboside Supplementation and Exercise Training to Promote Metabolic Health
- ClinicalTrials.gov ID
- NCT06425042
- Acronym / sponsor ID
- RESTORENAD / 23-041
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Finis Terrae UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NR+EXTR | Experimental | Dietary Supplement: Nicotinamide Riboside (NR)This arm will ingest NR orally and perform exercise training |
| PLA+EXTR | Placebo comparator | Dietary Supplement: PlaceboThis arm will ingest placebo orally and perform exercise training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide Riboside (NR)Participants will ingest 1g/d of NR orally during 12 weeks in parallel to a exercise training program | Dietary supplement | NR+EXTR |
| PlaceboParticipants will ingest 1g/d of placebo orally during 12 weeks in parallel to a exercise training program | Dietary supplement | PLA+EXTR |
Primary outcome
Skeletal muscle mitochondrial respiratory capacity
Time frame: 12 weeks
Skeletal muscle mitochondrial respiratory capacity will be measured in permeabilized fibres.
14 secondary outcomes
Quantification of proteins that regulate oxidative metabolism
Time frame: 12 weeks
Skeletal muscle mitochondrial content
Time frame: 12 weeks
Maximal aerobic capacity
Time frame: 12 weeks
Walking speed and distance
Time frame: 12 weeks
Seating and standing transitions
Time frame: 12 weeks
Exercise efficiency
Time frame: 12 weeks
Intrahepatic liver fat content
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Total muscle mass
Time frame: 12 weeks
Total fat mass
Time frame: 12 weeks
Fat-free mass
Time frame: 12 weeks
NAD+ levels
Time frame: 12 weeks
24h Blood pressure
Time frame: 12 weeks
Resting energy expenditure
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside (NR) in people with Healthy Aging and Lifestyle-related Condition, run by Finis Terrae University at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Mancilla, PhD (+56953676588, rmancilla@uft.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle mitochondrial respiratory capacity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.