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

NCT05167903 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-22

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

OTHER

Normal Diet

All praticipants in ND will perform supervised and monitored RT three time per week for the 10 weeks of intervention. The ND group will consume all meals between 6 am - 10 pm (16 h eating window with 8 h of fasting, ad-libitum).

BEHAVIORAL

Time-restricted eating

All participants in TRE will perform supervised and monitored RT three time per week for the 10 weeks of intervention. Participants in the TRE group will be instructed to consume all meals between 12pm to 8pm, and to avoid consumption of food or caloric drinks during the fasting period (8 h eating window with 16 h of fasting).

Sponsors & Collaborators

  • Tel Aviv University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2024-07-30
Completion
2024-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05167903 on ClinicalTrials.gov