Slow Age: Interventions to Slow Aging in Humans

Aging Clinical Trial

— SlowAge  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05593939
• Other study ID #: H-21017723
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: September 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Elysium Health

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6 levels in plasma		Day 1 compared to day 84
Secondary	Concentration of CRP in plasma		Day 1 compared to day 84
Secondary	Concentration of TNF-a in plasma		Day 1 compared to day 84
Secondary	Concentration of NAD in whole blood		Day 1 compared to day 84
Secondary	Change in fat mass	Measured using bio-impedance	Day 1 compared to day 84
Secondary	Change in lean mass	Measured using bio-impedance	Day 1 compared to day 84
Secondary	Grip strength		Day 1 compared to day 84
Secondary	Gait speed	Measured over 4 meters.	Day 1 compared to day 84
Secondary	Predicted age (DNA methylation)	From PBMCs	Day 1 compared to day 84
Secondary	Predicted age (Blood age)	From 33 blood parameters	Day 1 compared to day 84
Secondary	Predicted age (Transcriptomics)	From RNA seq of PBMCs	Day 1 compared to day 84
Secondary	Predicted age (voice)	From voice recordings	Day 1 compared to day 84
Secondary	Predicted age (photo)	From a portrait photo	Day 1 compared to day 84