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Slow Age: Interventions to Slow Aging in Humans (SlowAge)

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ClinicalTrials.gov Identifier: NCT05593939
Recruitment Status : Completed
First Posted : October 26, 2022
Last Update Posted : April 25, 2023
Sponsor:
Collaborator:
Elysium Health
Information provided by (Responsible Party):
University of Copenhagen

Tracking Information
First Submitted Date  ICMJE September 27, 2022
First Posted Date  ICMJE October 26, 2022
Last Update Posted Date April 25, 2023
Actual Study Start Date  ICMJE May 1, 2022
Actual Primary Completion Date December 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2022)
Interleukin-6 levels in plasma [ Time Frame: Day 1 compared to day 84 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2022)
  • 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 ]
    Measured using bio-impedance
  • Change in lean mass [ Time Frame: Day 1 compared to day 84 ]
    Measured using bio-impedance
  • Grip strength [ Time Frame: Day 1 compared to day 84 ]
  • Gait speed [ Time Frame: Day 1 compared to day 84 ]
    Measured over 4 meters.
  • Predicted age (DNA methylation) [ Time Frame: Day 1 compared to day 84 ]
    From PBMCs
  • Predicted age (Blood age) [ Time Frame: Day 1 compared to day 84 ]
    From 33 blood parameters
  • Predicted age (Transcriptomics) [ Time Frame: Day 1 compared to day 84 ]
    From RNA seq of PBMCs
  • Predicted age (voice) [ Time Frame: Day 1 compared to day 84 ]
    From voice recordings
  • Predicted age (photo) [ Time Frame: Day 1 compared to day 84 ]
    From a portrait photo
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Slow Age: Interventions to Slow Aging in Humans
Official Title  ICMJE Slow Age: a Randomized, Controlled Clinical Trial of Interventions to Slow Aging in Humans
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Aging
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Exercise arm
    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.
    Intervention: Behavioral: Exercise
  • Experimental: Time restricted feeding
    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.
    Intervention: Behavioral: Time restricted feeding
  • Experimental: Nicotinamide riboside
    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.
    Intervention: Dietary Supplement: Nicotinamide riboside
  • No Intervention: Control
    A control group with no intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2022)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 21, 2022
Actual Primary Completion Date December 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05593939
Other Study ID Numbers  ICMJE H-21017723
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This is not possible under current data protection rules.
Current Responsible Party University of Copenhagen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Copenhagen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Elysium Health
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP