FAXAGE: Fasting and exercise to slow aging in older adults.
FAXAGE: A Randomized, Controlled Clinical Trial Of Fasting And Exercise To Slow Aging In Humans
This project will test whether time-restricted eating, exercise, or both can slow biological aging in people 65 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen, Copenhagen N) |
| Trial ID | NCT07207044 on ClinicalTrials.gov |
What this trial studies
FAXAge is a randomized, controlled one-year intervention enrolling 240 adults aged 65 and older who will be assigned to time-restricted feeding, supervised exercise, a combined intervention, or a control group. A reference cohort aged 20+ balanced by age and sex will be used to train algorithms for estimating biological age, while participants undergo repeated measures of physical, molecular, and digital biomarkers. Biomarkers include DNA-methylation, VO2max, body composition, and face- and voice-age, with measurements at baseline, 3 months, 6 months, and week 52. The primary outcome is DNA-methylation age at week 52 and secondary outcomes are the other biomarker changes and functional measures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older in generally good health (no more than one well-managed chronic disease), non-smokers who can commit to one year of time-restricted eating and/or supervised exercise and attend regular testing visits.
Not a fit: People with severe or uncontrolled medical conditions, current time-restricted eating habits, regular high-intensity exercise (>1 hour/week), active smoking, or use of systemic glucocorticoids or hormonal therapies are likely excluded or less likely to benefit.
Why it matters
Potential benefit: If successful, the interventions could slow biological aging as measured by DNA-methylation and improve physical fitness and body composition in older adults.
How similar studies have performed: Prior studies have shown metabolic and functional benefits from intermittent fasting and exercise and some small studies report changes in epigenetic aging markers, but large randomized trials showing durable reductions in DNA-methylation age are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen, Copenhagen N
- University of Copenhagen — Copenhagen, Copenhagen N, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.