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

NCT05167903 | Recruiting DMC

• 1 other identifier: 0057-21-ASF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Time-restricted eating; muscle mass; strength; cardio-metabolic risk

Outcome Measures

Primary Outcomes (3)

• Primary aim muscle mass

  Muscle mass volume using MRI (cm3)

  10 weeks

• Primary aim free fat mass

  Free fat mass will be mesured in in kg using DXA , BOD POD and BIA

  10 weeks

• Primary aim Maximum strength

  Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)

  10 weeks

Secondary Outcomes (2)

• Secondary aims Cardiometabolic profile

  10 weeks

• Secondary aims body composition assessment

  10 weeks

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

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)

Behavioral: Time-restricted eating

Normal Diet (ND)

EXPERIMENTAL

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

Other: Normal Diet

Interventions

Normal Diet 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).

Also known as: ND

Normal Diet (ND)

Time-restricted eating 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).

Also known as: TRE

Time-restricted eating

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, Other, 6997801, Israel

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Intermittent Fasting

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior

Central Study Contacts

Yftach Gepner, Ph.D.

CONTACT

0506828501; gepner@tauex.tau.ac.il

Shay Efrati, MD

CONTACT

0549212866; efratishai@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: December 22, 2021
• Study Start: May 15, 2022
• Primary Completion: July 30, 2024
• Study Completion: December 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)