The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health
Primary Purpose
Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Normal Diet
Time-restricted eating
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Time-restricted eating, muscle mass, strength, cardio-metabolic risk
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
Sites / Locations
- Tel Aviv UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Time-restricted eating
Normal Diet (ND)
Arm Description
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)
The ND group will consume all meals between 6 am - 10 pm (16 h eating window with 8 h of fasting, ad-libitum)
Outcomes
Primary Outcome Measures
Primary aim muscle mass
Muscle mass volume using MRI (cm3)
Primary aim free fat mass
Free fat mass will be mesured in in kg using DXA , BOD POD and BIA
Primary aim Maximum strength
Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)
Secondary Outcome Measures
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
Secondary aims body composition assessment
Body composition assessment fat mass (kg) using DXA, BOD POD and BIA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05167903
Brief Title
The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health
Official Title
The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health; Randomized Controlled Trial (TERA)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Time-restricted eating, muscle mass, strength, cardio-metabolic risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Time-restricted eating
Arm Type
Experimental
Arm Description
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)
Arm Title
Normal Diet (ND)
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Normal Diet
Other Intervention Name(s)
ND
Intervention Description
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
Behavioral
Intervention Name(s)
Time-restricted eating
Other Intervention Name(s)
TRE
Intervention Description
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).
Primary Outcome Measure Information:
Title
Primary aim muscle mass
Description
Muscle mass volume using MRI (cm3)
Time Frame
10 weeks
Title
Primary aim free fat mass
Description
Free fat mass will be mesured in in kg using DXA , BOD POD and BIA
Time Frame
10 weeks
Title
Primary aim Maximum strength
Description
Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Secondary aims Cardiometabolic profile
Description
Cardiometabolic profile [glucose (mg/dl), total cholesterol (mg/dl), HDL (mg/dl), LDL (mg/dl), TG (mg/dl)] will be mesured using blood test
Time Frame
10 weeks
Title
Secondary aims body composition assessment
Description
Body composition assessment fat mass (kg) using DXA, BOD POD and BIA
Time Frame
10 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-representation of gender identity.
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yftach Gepner, Ph.D.
Phone
0506828501
Email
gepner@tauex.tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Shay Efrati, MD
Phone
0549212866
Email
efratishai@outlook.com
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
State/Province
Other
ZIP/Postal Code
6997801
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yftach Gepner
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health
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