Clinical trial NCT05167903: The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health
Official title: The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health; Randomized Controlled Trial (TERA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Time-restricted eating
muscle mass
strength
cardio-metabolic risk
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Primary aim. Determine the effect of TRE or ND, combined with RT training, on muscle mass and strength as adaptive response to 10 weeks of intervention among people with metabolic syndrome.

Secondary aims. Determine the effect of TRE combined with RT on cardiometabolic health lipid profile and HbA1C (C), Mitochondria function and oxygen consumption (D) and Body composition assessment (E).

Eligibility criteria: 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

Primary outcomes:
measure: Primary aim muscle mass
timeFrame: 10 weeks
measure: Primary aim free fat mass
timeFrame: 10 weeks
measure: Primary aim Maximum strength
timeFrame: 10 weeks
Secondary outcomes:
measure: Secondary aims Cardiometabolic profile
timeFrame: 10 weeks
measure: Secondary aims body composition assessment
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
state: Other
Study officials:
References: