AgingPhase 2SlowAgeNCT05593939
Slow Age: Interventions to Slow Aging in Humans
A Phase 2 study testing Exercise, Time restricted feeding and Nicotinamide riboside in people with Aging, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The proportion of older individuals is growing, and it is therefore important to investigate ways to promote healthy aging. Exercise is one of the most studied interventions and is known to have a variety of health benefits. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Exercise, Time restricted feeding and Nicotinamide riboside
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2022to 21 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged ≥ 65 years
- In good general health
Who cannot join
- Inability or unwillingness to take oral supplements
- Inability or unwillingness to adhere to the fasting regiment
- Inability or unwillingness to perform the prescribed physical exercise
- Current smoker or use of any nicotine products within 10 years
- Chronic use of supplements containing vitamin B or nicotinamide riboside
- Treatment with another investigational drug or other intervention within 1 year
- Cancer diagnosis within last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Slow Age: a Randomized, Controlled Clinical Trial of Interventions to Slow Aging in Humans
The proportion of older individuals is growing, and it is therefore important to investigate ways to promote healthy aging. Exercise is one of the most studied interventions and is known to have a variety of health benefits. Dietary interventions have also shown encouraging results, with intermittent fasting being a promising anti-aging intervention. Likewise, dietary supplementation with precursors that can increase the central metabolite nicotinamide dinucleotide (NAD+) has powerful effects on aging at least in model organisms. Although physical exercise is known to increase health-span, the effects of these latter dietary interventions on aging lacks evidence in humans.
This is a randomized, controlled trial of interventions to slow aging in humans. Healthy older individuals will be randomized into either an aerobic exercise (EXE), time-restricted feeding (TRF), nicotinamide riboside (NR), or control group and followed for twelve weeks. Changes in biomarkers of aging will be assessed before and after the intervention. It is hypothesized that the interventions provide similar, superior benefits to these markers when compared to placebo.
Primary Outcome: Interleukin-6 levels. Secondary Outcomes: CRP, TNF-α, NAD+, hematologic age, epigenetic age (DNA methylation), transcriptomic age (RNA-sequencing), functional age (handgrip strength, gait speed), body composition, vocal age, and photo age
- Conditions
- Aging
- Being tested
- Exercise, Time restricted feeding, Nicotinamide riboside
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants randomized to the EXE group will perform aerobic exercise five days per week, totaling 150-300 min/week, at moderate to vigorous intensities i.e., ~60-90% heart rate (HR) max. Participants randomized to the EXE group will perform aerobic exercise five days per week, totaling 150-300 min/week, at moderate to vigorous intensities i.e., ~60-90% heart rate (HR) max. Exercise intensity and duration will gradually increase up until week 3 to habituate the participants to the exercise. The training modality will change to reduce the risk of injuries and may be impacted by individual preferences to increase adherence. The training can be performed individually or in groups of 4-6 participants, depending on the geographical locations of the participants home address, and on the current recruitment rate.
Time restricted feedingBehavioural
Participants randomized to the time restricted feeding group will be instructed to abstain from any caloric intake during the targeted fasting window of 16 continuous hours and consume ad libitum during the eating window of 8 hours.
Nicotinamide ribosideDietary supplement
Participants randomized to the NR group will be instructed to take the administered tablets once in the morning (1 g) and once in the evening (1 g), in both cases with a meal.
| Study group | Role | What they receive |
|---|---|---|
| Exercise arm | Experimental | 12 week aerobic exercise will be performed in agreement with current guidelines for exercise in older adults from the American College of Sports Medicine. A frequency of 5 days/week, totaling 150-300 min/week, performed at both moderate and vigorous intensities is chosen. This dose has a high level of evidence supporting positive effects on health- and life-span. Receives: Behavioral: Exercise |
| Time restricted feeding | Experimental | A 12 week fasting/feeding regiment of 16 hours fasting /8 hours feeding each day is chosen. This ratio has been shown to be tolerable in older individuals. Receives: Behavioral: Time restricted feeding |
| Nicotinamide riboside | Experimental | Previous clinical trials have shown that an nicotinamide riboside dose up to 2 g/day is well tolerated with no treatment-emergent adverse events reported so far and with efficacy on our primary outcome measurement. A dose of 2 g/day NR is therefore chosen and will be split in two: 1 g in the morning and 1 g in the evening. Receives: Dietary Supplement: Nicotinamide riboside |
| Control | No intervention | A control group with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 levels in plasma
Measured: Day 1 compared to day 84
Secondary outcomes (12)
Concentration of CRP in plasma
Measured: Day 1 compared to day 84
Concentration of TNF-α in plasma
Measured: Day 1 compared to day 84
Concentration of NAD in whole blood
Measured: Day 1 compared to day 84
Change in fat mass
Measured using bio-impedance
Measured: Day 1 compared to day 84
Change in lean mass
Measured using bio-impedance
Measured: Day 1 compared to day 84
Grip strength
Measured: Day 1 compared to day 84
Gait speed
Measured over 4 meters.
Measured: Day 1 compared to day 84
Predicted age (DNA methylation)
From PBMCs
Measured: Day 1 compared to day 84
Predicted age (Blood age)
From 33 blood parameters
Measured: Day 1 compared to day 84
Predicted age (Transcriptomics)
From RNA seq of PBMCs
Measured: Day 1 compared to day 84
Predicted age (voice)
From voice recordings
Measured: Day 1 compared to day 84
Predicted age (photo)
From a portrait photo
Measured: Day 1 compared to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 May 2022
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Elysium Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593939
- Sponsor's protocol ID
- H-21017723
- Acronym
- SlowAge
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not possible under current data protection rules.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Age: a Randomized, Controlled Clinical Trial of Interventions to Slow Aging in Humans
- ClinicalTrials.gov ID
- NCT05593939
- Acronym / sponsor ID
- SlowAge / H-21017723
- Conditions
- Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Elysium Health
- Study start
- 1 May 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 26 Oct 2022 (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 proportion of older individuals is growing, and it is therefore important to investigate ways to promote healthy aging. Exercise is one of the most studied interventions and is known to have a variety of health benefits. Dietary interventions have also shown encouraging results, with intermittent fasting being a promising anti-aging intervention. Likewise, dietary supplementation with precursors that can increase the central metabolite nicotinamide dinucleotide (NAD+) has powerful effects on aging at least in model organisms. Although physical exercise is known to increase health-span, the effects of these latter dietary interventions on aging lacks evidence in humans.
This is a randomized, controlled trial of interventions to slow aging in humans. Healthy older individuals will be randomized into either an aerobic exercise (EXE), time-restricted feeding (TRF), nicotinamide riboside (NR), or control group and followed for twelve weeks. Changes in biomarkers of aging will be assessed before and after the intervention. It is hypothesized that the interventions provide similar, superior benefits to these markers when compared to placebo.
Primary Outcome: Interleukin-6 levels. Secondary Outcomes: CRP, TNF-α, NAD+, hematologic age, epigenetic age (DNA methylation), transcriptomic age (RNA-sequencing), functional age (handgrip strength, gait speed), body composition, vocal age, and photo age
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise arm | Experimental | Behavioral: Exercise12 week aerobic exercise will be performed in agreement with current guidelines for exercise in older adults from the American College of Sports Medicine. A frequency of 5 days/week, totaling 150-300 min/week, performed at both moderate and vigorous intensities is chosen. This dose has a high level of evidence supporting positive effects on health- and life-span. |
| Time restricted feeding | Experimental | Behavioral: Time restricted feedingA 12 week fasting/feeding regiment of 16 hours fasting /8 hours feeding each day is chosen. This ratio has been shown to be tolerable in older individuals. |
| Nicotinamide riboside | Experimental | Dietary Supplement: Nicotinamide ribosidePrevious clinical trials have shown that an nicotinamide riboside dose up to 2 g/day is well tolerated with no treatment-emergent adverse events reported so far and with efficacy on our primary outcome measurement. A dose of 2 g/day NR is therefore chosen and will be split in two: 1 g in the morning and 1 g in the evening. |
| Control | No intervention | –A control group with no intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged ≥ 65 years
- In good general health
Key exclusion criteria (7 listed)
- Inability or unwillingness to take oral supplements
- Inability or unwillingness to adhere to the fasting regiment
- Inability or unwillingness to perform the prescribed physical exercise
- Current smoker or use of any nicotine products within 10 years
- Chronic use of supplements containing vitamin B or nicotinamide riboside
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 |
|---|---|---|
| ExerciseParticipants randomized to the EXE group will perform aerobic exercise five days per week, totaling 150-300 min/week, at moderate to vigorous intensities i.e., ~60-90% heart rate (HR) max. Participants randomized to the EXE group will perform aerobic exercise five days per week, totaling 150-300 min/week, at moderate to vigorous intensities i.e., ~60-90% heart rate (HR) max. Exercise intensity and duration will gradually increase up until week 3 to habituate the participants to the exercise. The training modality will change to reduce the risk of injuries and may be impacted by individual preferences to increase adherence. The training can be performed individually or in groups of 4-6 participants, depending on the geographical locations of the participants home address, and on the current recruitment rate. | Behavioural | Exercise arm |
| Time restricted feedingParticipants randomized to the time restricted feeding group will be instructed to abstain from any caloric intake during the targeted fasting window of 16 continuous hours and consume ad libitum during the eating window of 8 hours. | Behavioural | Time restricted feeding |
| Nicotinamide ribosideParticipants randomized to the NR group will be instructed to take the administered tablets once in the morning (1 g) and once in the evening (1 g), in both cases with a meal. | Dietary supplement | Nicotinamide riboside |
Primary outcome
Interleukin-6 levels in plasma
Time frame: Day 1 compared to day 84
12 secondary outcomes
Concentration of CRP in plasma
Time frame: Day 1 compared to day 84
Concentration of TNF-α in plasma
Time frame: Day 1 compared to day 84
Concentration of NAD in whole blood
Time frame: Day 1 compared to day 84
Change in fat mass
Time frame: Day 1 compared to day 84
Change in lean mass
Time frame: Day 1 compared to day 84
Grip strength
Time frame: Day 1 compared to day 84
Gait speed
Time frame: Day 1 compared to day 84
Predicted age (DNA methylation)
Time frame: Day 1 compared to day 84
Predicted age (Blood age)
Time frame: Day 1 compared to day 84
Predicted age (Transcriptomics)
Time frame: Day 1 compared to day 84
Predicted age (voice)
Time frame: Day 1 compared to day 84
Predicted age (photo)
Time frame: Day 1 compared to day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No. This is not possible under current data protection rules.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise, Time restricted feeding and Nicotinamide riboside in people with Aging, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 25 Apr 2023. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 levels in plasma (time frame: Day 1 compared to day 84). 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 25 Apr 2023; AzTrials last refreshed its copy on 3 Nov 2026.