FAXAGE: Fasting And Exercise To Slow Aging In Humans

NCT07207044 | Recruiting

• 1 other identifier: H-25020642
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

FAXAge is a randomized controlled trial investigating the effects of fasting and exercise on human aging. 240 participants over the age of 65 will be divided into 4 groups - an exercise group, a fasting group, a combined exercise and fasting group and a control group. The intervention will last for one year, and tests of biomarkers of aging will be performed at baseline, after 3 months, 6 months and at the end of the intervention. A reference group of participants over the age of 20 equally distributed by age and sex will be used to train an algorithm for determination of biological age. The study will include both physical, molecular and digital biomarkers including DNA-methylation, VO2max, body composition and face- and voice-age. The main outcome of the project is DNA-methylation age at week 52. Secondary outcomes are the rest of the tested biomarkers at week 52. It is hypothesised that the intervention groups will have similar superior benefits after the 52 weeks of intervention.

Conditions

Aging; Healthy Aging; Aging Frailty

Outcome Measures

Primary Outcomes (1)

• DNA-methylation age

  Changes in predicted biological age from baseline based on DNA-methylation from isolated peripheral blood mononucleated cells after 52 weeks of intervention

  From enrollment until end of intervention at 52 weeks

Study Arms (4)

TRF

EXPERIMENTAL

Behavioral: Time-restricted feeding

EXE

EXPERIMENTAL

Behavioral: Exercise - Strength + Cardio

FAX

EXPERIMENTAL

Behavioral: Time-restricted feeding + Exercise

CON

NO INTERVENTION

Interventions

Exercise - Strength + Cardio BEHAVIORAL

Supervised strength training 2x/week + self-administered cardio training 2x/week.

EXE

Time-restricted feeding BEHAVIORAL

Time-restricted feeding in a 16/8 regimen - 16 hours of fast and 8 hours of eating per day.

TRF

Time-restricted feeding + Exercise BEHAVIORAL

Strength and cardio exercise 2x/week each combined with time-restricted feeding in a 16/8 regimen.

FAX

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Aged \>20 years
• In good general health meaning maximally 1 well-managed chronic disease
• Non-smoker.

You may not qualify if:

• Inability or unwillingness to adhere to the TRF regiment
• Inability or unwillingness to perform the prescribed physical exercise
• Treatment with other investigational drug or intervention within 1 year
• \>1 hour of systematic strenuous exercise or strength training a week
• Current time-restricted eating habits
• Severe or dysregulated medical disease (i.e. active cancer, uncontrolled diabetes, severe pulmonary or heart disease)
• \>1 well-managed chronic disease
• Smoker
• Use of systemic glucocorticoids, androgens or antiandrogens.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, Copenhagen N, 2200, Denmark

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2042
• Last Updated: January 28, 2026

Record last verified: 2025-09

Locations

DK (1)