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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167903
• Other study ID #: 0057-21-ASF
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Tel Aviv University
• Contact: Yftach Gepner, Ph.D.
• Phone: 0506828501
• Email: gepner[@]tauex.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

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).

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv	Other

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary aim muscle mass	Muscle mass volume using MRI (cm3)	10 weeks
Primary	Primary aim free fat mass	Free fat mass will be mesured in in kg using DXA , BOD POD and BIA	10 weeks
Primary	Primary aim Maximum strength	Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)	10 weeks
Secondary	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	Secondary aims body composition assessment	Body composition assessment fat mass (kg) using DXA, BOD POD and BIA	10 weeks