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NCT Number: NCT05593939

Slow Age: 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

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Key information

Conditions

Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Copenhagen

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exercise

Behavioral

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

Behavioral

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 riboside

Dietary 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.

Primary outcomes

  1. Interleukin-6 levels in plasma

    Time frame: Day 1 compared to day 84

Secondary outcomes

  1. Concentration of CRP in plasma

    Time frame: Day 1 compared to day 84

  2. Concentration of TNF-α in plasma

    Time frame: Day 1 compared to day 84

  3. Concentration of NAD in whole blood

    Time frame: Day 1 compared to day 84

  4. Change in fat mass

    Time frame: Day 1 compared to day 84

    Measured using bio-impedance

  5. Change in lean mass

    Time frame: Day 1 compared to day 84

    Measured using bio-impedance

  6. Grip strength

    Time frame: Day 1 compared to day 84

  7. Gait speed

    Time frame: Day 1 compared to day 84

    Measured over 4 meters.

  8. Predicted age (DNA methylation)

    Time frame: Day 1 compared to day 84

    From PBMCs

  9. Predicted age (Blood age)

    Time frame: Day 1 compared to day 84

    From 33 blood parameters

  10. Predicted age (Transcriptomics)

    Time frame: Day 1 compared to day 84

    From RNA seq of PBMCs

  11. Predicted age (voice)

    Time frame: Day 1 compared to day 84

    From voice recordings

  12. Predicted age (photo)

    Time frame: Day 1 compared to day 84

    From a portrait photo

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Elysium Health

Registry information

Official study title

Slow Age: a Randomized, Controlled Clinical Trial of Interventions to Slow Aging in Humans

Acronym: SlowAge

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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