The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health

Tel Aviv University

Status: Enrolling

Conditions: Metabolic Syndrome

Treatments: Behavioral: Time-restricted eating; Other: Normal Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05167903

0057-21-ASF

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Time-restricted eating

Experimental group

Description:

Participants in the TRE group will be instructed to consume all meals between 12pm to 8pm (8 h eating window with 16 h of fasting)

Treatment:

Behavioral: Time-restricted eating

Normal Diet (ND)

Experimental group

Description:

The ND group will consume all meals between 6 am - 10 pm (16 h eating window with 8 h of fasting, ad-libitum)

Treatment:

Other: Normal Diet