Clinical trial NCT05593939: Slow Age: Interventions to Slow Aging in Humans
Official title: Slow Age: a Randomized, Controlled Clinical Trial of Interventions to Slow Aging in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aging
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Elysium Health
First posted: 2022-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Interleukin-6 levels in plasma
timeFrame: Day 1 compared to day 84
Secondary outcomes:
measure: Concentration of CRP in plasma
timeFrame: Day 1 compared to day 84
measure: Concentration of TNF-α in plasma
timeFrame: Day 1 compared to day 84
measure: Concentration of NAD in whole blood
timeFrame: Day 1 compared to day 84
measure: Change in fat mass
timeFrame: Day 1 compared to day 84
measure: Change in lean mass
timeFrame: Day 1 compared to day 84
measure: Grip strength
timeFrame: Day 1 compared to day 84
measure: Gait speed
timeFrame: Day 1 compared to day 84
measure: Predicted age (DNA methylation)
timeFrame: Day 1 compared to day 84
measure: Predicted age (Blood age)
timeFrame: Day 1 compared to day 84
measure: Predicted age (Transcriptomics)
timeFrame: Day 1 compared to day 84
measure: Predicted age (voice)
timeFrame: Day 1 compared to day 84
measure: Predicted age (photo)
timeFrame: Day 1 compared to day 84
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References: