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

NCT ID: NCT05167903

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2024-12-01

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).

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Time-restricted eating

Intervention Type: BEHAVIORAL

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).

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)

Group Type: EXPERIMENTAL

Normal Diet

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

ND; TRE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Gepner Yftach

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tel Aviv University

Tel Aviv, Other, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yftach Gepner, Ph.D.

Role: CONTACT

gepner@tauex.tau.ac.il

0506828501

Shay Efrati, MD

Role: CONTACT

efratishai@outlook.com

0549212866

Facility Contacts

Yftach Gepner

Role: primary

Other Identifiers

0057-21-ASF

Identifier Type: -

Identifier Source: org_study_id