Slow Age: Interventions to Slow Aging in Humans

Phase 2

Completed

• Conditions: Aging
• Interventions: Dietary Supplement: Nicotinamide riboside; Behavioral: Exercise; Behavioral: Time restricted feeding

• Registration Number: NCT05593939
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-26
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotinamide riboside	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.
Exercise arm	Exercise	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.
Time restricted feeding	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.

Primary Outcome Measures

Name	Time	Method
Interleukin-6 levels in plasma	Day 1 compared to day 84

Secondary Outcome Measures

Name	Time	Method
Grip strength	Day 1 compared to day 84
Predicted age (Blood age)	Day 1 compared to day 84	From 33 blood parameters
Predicted age (Transcriptomics)	Day 1 compared to day 84	From RNA seq of PBMCs
Predicted age (voice)	Day 1 compared to day 84	From voice recordings
Change in fat mass	Day 1 compared to day 84	Measured using bio-impedance
Concentration of CRP in plasma	Day 1 compared to day 84
Concentration of TNF-α in plasma	Day 1 compared to day 84
Concentration of NAD in whole blood	Day 1 compared to day 84
Change in lean mass	Day 1 compared to day 84	Measured using bio-impedance
Gait speed	Day 1 compared to day 84	Measured over 4 meters.
Predicted age (DNA methylation)	Day 1 compared to day 84	From PBMCs
Predicted age (photo)	Day 1 compared to day 84	From a portrait photo

Trial Locations

Locations (1)

University of Copenhagen; 🇩🇰 Copenhagen, Denmark