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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

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


Condition or disease Intervention/treatment Phase
Aging Behavioral: Exercise Behavioral: Time restricted feeding Dietary Supplement: Nicotinamide riboside Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Slow Age: a Randomized, Controlled Clinical Trial of Interventions to Slow Aging in Humans
Actual Study Start Date : May 1, 2022
Actual Primary Completion Date : December 21, 2022
Actual Study Completion Date : December 21, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.

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.
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.

No Intervention: Control
A control group with no intervention.



Primary Outcome Measures :
  1. Interleukin-6 levels in plasma [ Time Frame: Day 1 compared to day 84 ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05593939


Locations
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Denmark
University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Elysium Health
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Responsible Party: University of Copenhagen
ClinicalTrials.gov Identifier: NCT05593939    
Other Study ID Numbers: H-21017723
First Posted: October 26, 2022    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not possible under current data protection rules.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents