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

Sponsor

Tel Aviv University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05167903

Collaborator

(none)

Enrollment

Arms

14.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: Normal Diet Behavioral: Time-restricted eating	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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:

Outcome Measures

Primary Outcome Measures

Primary aim muscle mass [10 weeks]
Muscle mass volume using MRI (cm3)
Primary aim free fat mass [10 weeks]
Free fat mass will be mesured in in kg using DXA , BOD POD and BIA
Primary aim Maximum strength [10 weeks]
Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tel Aviv University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gepner Yftach, Principal Investigator, Tel Aviv University

ClinicalTrials.gov Identifier:

NCT05167903

Other Study ID Numbers:

0057-21-ASF

First Posted:

Dec 22, 2021

Last Update Posted:

Feb 22, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gepner Yftach, Principal Investigator, Tel Aviv University

Time-restricted eating

muscle mass

strength

cardio-metabolic risk

Additional relevant MeSH terms:

Metabolic Syndrome

Study Results

No Results Posted as of Feb 22, 2022