The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Card… (NCT05167903) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health
Israel50 participantsStarted 2022-05-15
Plain-language summary
The aim of the study is to determine the effect of resistance training (RT) combined with time-restricted eating (TRE) or normal diet (ND) on muscle mass, and strength. Additionally, the study will compare between TRE and ND and its effects on cardiometabolic health, mitochondria function and body composition among people with metabolic syndrome.
In this randomized controlled trial, 50 males with metabolic syndrome (elevated waist circumference, blood pressure, triglycerides, fasting glucose and low high-density lipoprotein cholesterol) between the age of 40-60y and with BMI between 25-33 kg/m2 will be randomized to either TRE+RT (n=25) or ND+RT (n=25). All participants will perform supervised and monitored RT three time per week for the 10 weeks of intervention Study measurements; Changes in body composition, muscle mass and adipose tissue distribution will be measured by 3-Tesla magnetic resonance imaging (MRI), dual energy x-ray absorptiometry (DXA), air displacement plethysmography (BODPOD) and Bioelectrical Impedance analysis (BIA). Muscular Strength will be assessed. Blood samples, including lipid and glycemic profile. muscle biopsy taken from the vastus lateralis muscle.
Who can participate
Age range
40 Years – 60 Years
Sex
MALE
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:
* Subject with metabolic syndrome
* BMI between 25-33 kg/m²
* Age 40-60
* Without cardiac and pulmonary disease
* Did not engage exercise training in the last year.
* Willing and able to read, understand and sign an informed consent
Exclusion Criteria:
* Participants that have cardiopulmonary disease
* Inability to attend scheduled clinic visits and/or comply with the study protocol
* Active smokers
* Previous regular exercise training in the previous yea
* Major orthopedic injury at the past 3 months
* Inability to perform an MRI (due to claustrophobia, or metal in their body)
* Subjects that uses drugs that affect muscle metabolism
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.
1This trial combines time-restricted eating with exercise training to look at muscle mass, fat mass, and maximum strength in people with metabolic syndrome — given my specific situation, does my doctor think focusing on both diet timing and exercise at once is safe and realistic for me right now?
2The trial's recruitment status is listed as unknown, so before I invest time looking into it, can my doctor help me find out whether it's still actively enrolling or whether there's a similar study I could consider instead?
3Since this study is measuring muscle mass as a primary outcome, and time-restricted eating can sometimes make it harder to maintain muscle, what does my doctor think about the risk of muscle loss for someone with my current health profile?
4This appears to be a lifestyle intervention trial rather than a drug trial — how does my doctor weigh this kind of structured program against simply working with a dietitian and a personal trainer on my own, outside of a trial setting?
5Metabolic syndrome often involves multiple conditions like high blood pressure or blood sugar — are there any aspects of my current health that my doctor thinks could make the exercise or fasting components of this trial harder or riskier for me to do safely?
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.