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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05593939
Other study ID # H-21017723
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 1, 2022
Est. completion date December 21, 2022

Study information

Verified date September 2022
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 21, 2022
Est. primary completion date December 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Aged = 65 years 4. In good general health Exclusion Criteria: 1. Inability or unwillingness to take oral supplements 2. Inability or unwillingness to adhere to the fasting regiment 3. Inability or unwillingness to perform the prescribed physical exercise 4. Current smoker or use of any nicotine products within 10 years 5. Chronic use of supplements containing vitamin B or nicotinamide riboside 6. Treatment with another investigational drug or other intervention within 1 year 7. Cancer diagnosis within last 5 years

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
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 feeding
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.
Dietary Supplement:
Nicotinamide riboside
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.

Locations

Country Name City State
Denmark University of Copenhagen Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen Elysium Health

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interleukin-6 levels in plasma Day 1 compared to day 84
Secondary Concentration of CRP in plasma Day 1 compared to day 84
Secondary Concentration of TNF-a in plasma Day 1 compared to day 84
Secondary Concentration of NAD in whole blood Day 1 compared to day 84
Secondary Change in fat mass Measured using bio-impedance Day 1 compared to day 84
Secondary Change in lean mass Measured using bio-impedance Day 1 compared to day 84
Secondary Grip strength Day 1 compared to day 84
Secondary Gait speed Measured over 4 meters. Day 1 compared to day 84
Secondary Predicted age (DNA methylation) From PBMCs Day 1 compared to day 84
Secondary Predicted age (Blood age) From 33 blood parameters Day 1 compared to day 84
Secondary Predicted age (Transcriptomics) From RNA seq of PBMCs Day 1 compared to day 84
Secondary Predicted age (voice) From voice recordings Day 1 compared to day 84
Secondary Predicted age (photo) From a portrait photo Day 1 compared to day 84
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