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Recruiting NCT07207044

FAXAGE: Fasting And Exercise To Slow Aging In Humans

No phase Interventional Aging Healthy Aging Aging Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise - Strength + Cardio, Time-restricted feeding, Time-restricted feeding + Exercise.
Who it may be relevant to
Registry conditions: Aging, Healthy Aging, Aging Frailty. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

FAXAGE: A Randomized, Controlled Clinical Trial Of Fasting And Exercise To Slow Aging In Humans

Overview

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.

Interventions

  • Behavioral Exercise - Strength + Cardio
    Supervised strength training 2x/week + self-administered cardio training 2x/week.
  • Behavioral Time-restricted feeding
    Time-restricted feeding in a 16/8 regimen - 16 hours of fast and 8 hours of eating per day.
  • Behavioral Time-restricted feeding + Exercise
    Strength and cardio exercise 2x/week each combined with time-restricted feeding in a 16/8 regimen.

Primary outcome measures

  • DNA-methylation age [Time frame: From enrollment until end of intervention at 52 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Denmark · 1 center
  • University of Copenhagen — Copenhagen

Publications

  • Fals EB, Springborg EC, Berthelsen AB, Nyeman-Nielsen J, Larsen S, Scheibye-Knudsen M. Study protocol for FAXAge: a randomized, controlled clinical trial of fasting and exercise to slow aging in humans. Geroscience. 2026 Jun 29. doi: 10.1007/s11357-026-02362-0. Online ahead of print. PMID 42373885

Identifiers

NCT: NCT07207044 · H-25020642

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗