FAXAGE: Fasting And Exercise To Slow Aging In Humans
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorUniversity of Copenhagen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise - Strength + Cardio
BehavioralSupervised strength training 2x/week + self-administered cardio training 2x/week.
Time-restricted feeding
BehavioralTime-restricted feeding in a 16/8 regimen - 16 hours of fast and 8 hours of eating per day.
Time-restricted feeding + Exercise
BehavioralStrength and cardio exercise 2x/week each combined with time-restricted feeding in a 16/8 regimen.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: TRFExperimental treatment 1 intervention
Group B: EXEExperimental treatment 1 intervention
Group C: FAXExperimental treatment 1 intervention
Group D: CONNo intervention 0 interventions
Trial outcomes
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
Time frame
From enrollment until end of intervention at 52 weeksSponsors and contacts
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Source ClinicalTrials.gov