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NCT Number: NCT07207044

FAXAGE: Fasting And Exercise To Slow Aging In Humans

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.

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Copenhagen N, 2200, Denmark

Location status: Recruiting

Location contact

Morten Scheibye-Knudsen, MD

CONTACT

[email protected]

+4542507060

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise - Strength + Cardio

Behavioral

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

Time-restricted feeding

Behavioral

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

Time-restricted feeding + Exercise

Behavioral

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

Primary outcomes

  1. DNA-methylation age

    Time frame: From enrollment until end of intervention at 52 weeks

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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Acronym: FAXAGE

Important dates

Study start
2025
Primary completion
2027
Study completion
2042
First posted
Oct 3, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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