Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE (NCT05938205) | Clinical Trial Compass
CompletedNot Applicable
Multicomponent Analysis of phYsical Frailty BiomarkErs: Focus on Mitochondrial Health - MAYBE
Italy111 participantsStarted 2019-03-01
Plain-language summary
The study will be conducted in a group of obese sarcopenic patients (Sarco-Ob) aged \> 60 years on moderately hypocaloric diet therapy aimed at comparing the effect of a strength exercise protocol, combined or not with dietary supplementation with amino acids, on physical performance, muscle strength, body composition, muscle oxidative metabolism, and biomarkers of sarcopenia. The supplementation study will be conducted in a double-blind manner.
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Participants will be included in the study based on the following inclusion criteria:
* Older men and women between 60-80 years
* The presence of sarcopenic obesity was considered when the following two conditions were satisfied: Fat mass \> 34.8% and FFM \<90% of subject's ideal FFM.
* Resident in Verona (Italy)
* Stable weight in the previous 2 months
* Previously sedentary (less than one hour of exercise per week in the last 6 months)
* Signing of the informed consent for participation in the study
Exclusion criteria:
* Unstable angina or recent myocardial infarction
* Malignant or unstable arrhythmias
* Heart failure NYHA class \> II
* Severe respiratory failure
* Severe heart valve disease (i.e severe aortic stenosis or insufficiency)
* Abdominal and/or thoracic aneurysm
* Recent intracerebral or subdural haemorrhage
* Poorly controlled arterial hypertension
* Presence of pacemakers or metal prostheses
* Severe chronic renal failure
* Symptomatic musculoskeletal pathology
* Symptomatic disc herniation, arthrosis, acute joint, tendon and ligamentous injuries, hip and/or knee prostheses recently placed (\<6 months) or with joint instability, symptomatic or large inguinal or abdominal hernia
* Acute retinal detachment or bleeding
* Recent eye surgery (laser, cataract, retinal surgery, glaucoma surgery)
* History of malignant cancer within the previous 5 years
* Diagnosis of dementia
* Eating disorders
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline 1-repetition maximum with isokinetic dynamometer at 5-months