The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health; Randomized Controlled Trial (TERA)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Israel
Tel Aviv University
RECRUITING
Tel Aviv
Contact Information
Primary
Yftach Gepner, Ph.D.
gepner@tauex.tau.ac.il
0506828501
Backup
Shay Efrati, MD
efratishai@outlook.com
0549212866
Time Frame
Start Date: 2022-05-15
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Time-restricted eating
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)
Experimental: Normal Diet (ND)
The ND group will consume all meals between 6 am - 10 pm (16 h eating window with 8 h of fasting, ad-libitum)
Related Therapeutic Areas
Sponsors
Leads: Tel Aviv University

This content was sourced from clinicaltrials.gov