Metabolic SyndromeNCT05167903
The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health
A study testing Normal Diet and Time-restricted eating in people with Metabolic Syndrome, run by Tel Aviv University at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Normal Diet and Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 15 May 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv, Other, 6997801
Yftach Gepner
About this study
Official title: 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.
Read the 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).
- Conditions
- Metabolic Syndrome
- Being tested
- Normal Diet, Time-restricted eating
- Keywords
- Time-restricted eating, muscle mass, strength, cardio-metabolic risk
- Medical subject headings
- Metabolic Syndrome, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal DietOther
Also called ND
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).
Time-restricted eatingBehavioural
Also called TRE
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Normal Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary aim muscle mass
Muscle mass volume using MRI (cm3)
Measured: 10 weeks
Primary aim free fat mass
Free fat mass will be mesured in in kg using DXA , BOD POD and BIA
Measured: 10 weeks
Primary aim Maximum strength
Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)
Measured: 10 weeks
Secondary outcomes (2)
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
Measured: 10 weeks
Secondary aims body composition assessment
Body composition assessment fat mass (kg) using DXA, BOD POD and BIA
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start15 May 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gepner Yftach, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167903
- Sponsor's protocol ID
- 0057-21-ASF
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2021
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-restricted Eating Combined With Exercise Training on Body Composition and Cardiometabolic Health; Randomized Controlled Trial (TERA)
- ClinicalTrials.gov ID
- NCT05167903
- Acronym / sponsor ID
- 0057-21-ASF
- Conditions
- Metabolic Syndrome
- Keywords
- Time-restricted eating, muscle mass, strength, cardio-metabolic risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | Experimental | Behavioral: Time-restricted eatingParticipants in the TRE group will be instructed to consume all meals between 12pm to 8pm (8 h eating window with 16 h of fasting) |
| Normal Diet (ND) | Experimental | Other: Normal DietThe ND group will consume all meals between 6 am - 10 pm (16 h eating window with 8 h of fasting, ad-libitum) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal DietAlso: NDAll 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 | Normal Diet (ND) |
| Time-restricted eatingAlso: TREAll 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). | Behavioural | Time-restricted eating |
Primary outcome
Primary aim muscle mass
Time frame: 10 weeks
Muscle mass volume using MRI (cm3)
Primary aim free fat mass
Time frame: 10 weeks
Free fat mass will be mesured in in kg using DXA , BOD POD and BIA
Primary aim Maximum strength
Time frame: 10 weeks
Maximum strength by one-repetition maximum (kg) using two exercise (bench press, hack squat)
2 secondary outcomes
Secondary aims Cardiometabolic profile
Time frame: 10 weeks
Secondary aims body composition assessment
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Diet and Time-restricted eating in people with Metabolic Syndrome, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yftach Gepner, Ph.D. (0506828501, gepner@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary aim muscle mass (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.