Slow Age: Interventions to Slow Aging in Humans

NCT ID: NCT05593939

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-21

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

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Time restricted feeding

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Nicotinamide riboside

Intervention Type: 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.

Control

A control group with no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Elysium Health

INDUSTRY

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-21017723

Identifier Type: -

Identifier Source: org_study_id