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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Time-restricted eating; Other: Normal Diet

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yftach Gepner, Ph.D.; Phone Number: 0506828501; Email: gepner@tauex.tau.ac.il
• Study Contact Backup: Name: Shay Efrati, MD; Phone Number: 0549212866; Email: efratishai@outlook.com

Study Locations

• Israel
  • Other
    • Tel Aviv, Other, Israel, 6997801
      • Recruiting
      • Tel Aviv University
      • Contact: Yftach Gepner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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).; Other Names: TRE
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)	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).; Other Names: ND

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary aims Cardiometabolic profile	Cardiometabolic profile [glucose (mg/dl), total cholesterol (mg/dl), HDL (mg/dl), LDL (mg/dl), TG (mg/dl)] will be mesured using blood test	10 weeks
Secondary aims body composition assessment	Body composition assessment fat mass (kg) using DXA, BOD POD and BIA	10 weeks

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: December 18, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: muscle mass; strength; Time-restricted eating; cardio-metabolic risk
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 0057-21-ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No