Metabolic SyndromeTRE-HIIT-METSNCT06501001
Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)
A study testing High-Intensity Interval Training and Experimental: Time-Restricted Eating in people with Metabolic Syndrome and Exercise, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Exercise, Weight Loss
- What is being tested?
- High-Intensity Interval Training and Experimental: Time-Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 27 Apr 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation):
- Waist circumference ≥ 92 cm (Men) or ≥ 80 cm (Women).
- Triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides).
- Reduced HDL-C < 40 mg/dL (Men), < 50 mg/dL (Women) (or on drug treatment for reduced HDL-C).
- Elevated blood pressure, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg (or treatment with an antihypertensive drug with a history of hypertension).
- Elevated fasting glucose ≥ 100 mg/dL (or drug treatment of elevated blood glucose).
- Age ≥18 to ≤65 years
- Previously inactive (<150 min·wk-1 of the moderate-intensity activity assessed by 7-d IPAQ
Who cannot join
- Pregnancy, and lactation within 24 weeks of study commencement
- Untreated cardiovascular or renal disease
- Type 1 diabetes
- Any condition associated with exercise intolerance.
- Habitual eating window < 12 hours
- Performing high-intensity training more than once a week
- Body mass variations > 4 kg three months prior to study commencement
- Shift work that includes night shifts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Restricted Eating and High-Intensity Interval Training to Improve Health in Patients With Metabolic Syndrome
Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Limited research in subjects with metabolic syndrome (MetS) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis.
This project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with MetS.
The intervention period will be sixteen weeks. Before and after the intervention, MetS components (i.e., MetS Z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. Physical activity, diet, sleep quality, and intervention adherence will also be measured.
- Conditions
- Metabolic Syndrome, Exercise, Weight Loss, Obesity, Cardiometabolic Syndrome, Time Restricted Eating
- Being tested
- High-Intensity Interval Training, Experimental: Time-Restricted Eating
- Keywords
- Metabolic syndrome, HIIT, Exercise training, Time restricted eating
- Medical subject headings
- Metabolic Syndrome, Motor Activity, Weight Loss, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
Three weekly, supervised exercise sessions with high intensity. Each session will last for 45 minutes. The intervention period will be sixteen weeks.
Experimental: Time-Restricted EatingBehavioural
Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training | Experimental | High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions. Receives: Behavioral: High-Intensity Interval Training |
| Time-Restricted Eating | Experimental | Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours Receives: Behavioral: Experimental: Time-Restricted Eating |
| High Intensity Interval Training & Time-Restricted Eating | Experimental | High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.
Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours Receives: Behavioral: High-Intensity Interval Training; Behavioral: Experimental: Time-Restricted Eating |
| Control | No intervention | Information about the recommended level of physical activity for health benefits and a healthy diet will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome Z score
MetS z score will be used to assess the continuous rather than dichotomous (have/not haveMetS) evolution of each MetS component into a compound score. We will calculate the Z score as the difference between the subjects and the threshold value divided by the group standard deviations for each MetS criterion.
Measured: Baseline and after 16 weeks of intervention
Secondary outcomes (8)
Blood lipids profile
Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting
Measured: Baseline and after 16 weeks of intervention
Glycemia
Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
Measured: Baseline and after 16 weeks of intervention
Blood pressure
Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.
Measured: Baseline and after 16 weeks of intervention
Central obesity
Measure waist circumference (cm) in a horizontal plane, midway between the ribs' inferior margin and the iliac crest's superior border.
Measured: Baseline and after 16 weeks of intervention
Body composition
Measurement of the mass of man body compartments (i.e., VAT [visceral adipose tissue] fat mass, fat-free mass, and bone mass) by dual-energy x-ray absorptiometry.
Measured: Baseline and after 16 weeks of intervention
Insulin
Serum concentrations of insulin after 8-hour fasting
Measured: Baseline and after 16 weeks of intervention
Insulin sensitivity
Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5)
Measured: Baseline and after 16 weeks of intervention
Cardiorespiratory fitness
Maximum oxygen uptake from a graded exercise test plus a verification test
Measured: Baseline and after 16 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Sep 2024
- Primary completion1 Apr 2026
- Study completion27 Apr 2026
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Morales Palomo, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501001
- Sponsor's protocol ID
- TRE-HIIT-METS
- Acronym
- TRE-HIIT-METS
- Status last verified
- May 2026
- First submitted
- 8 Jul 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating and High-Intensity Interval Training to Improve Health in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06501001
- Acronym / sponsor ID
- TRE-HIIT-METS / TRE-HIIT-METS
- Conditions
- Metabolic Syndrome, Exercise, Weight Loss, Obesity, Cardiometabolic Syndrome, Time Restricted Eating
- Keywords
- Metabolic syndrome, HIIT, Exercise training, Time restricted eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 15 Jul 2024 (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.
Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Limited research in subjects with metabolic syndrome (MetS) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis.
This project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with MetS.
The intervention period will be sixteen weeks. Before and after the intervention, MetS components (i.e., MetS Z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. Physical activity, diet, sleep quality, and intervention adherence will also be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training | Experimental | Behavioral: High-Intensity Interval TrainingHigh-intensity interval training for sixteen weeks. Three weekly, supervised training sessions. |
| Time-Restricted Eating | Experimental | Behavioral: Experimental: Time-Restricted EatingTime-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours |
| High Intensity Interval Training & Time-Restricted Eating | Experimental | Behavioral: High-Intensity Interval Training, Behavioral: Experimental: Time-Restricted EatingHigh-intensity interval training for sixteen weeks. Three weekly, supervised training sessions. Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours |
| Control | No intervention | –Information about the recommended level of physical activity for health benefits and a healthy diet will be given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation):
- Waist circumference ≥ 92 cm (Men) or ≥ 80 cm (Women).
- Triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides).
- Reduced HDL-C < 40 mg/dL (Men), < 50 mg/dL (Women) (or on drug treatment for reduced HDL-C).
- Elevated blood pressure, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg (or treatment with an antihypertensive drug with a history of hypertension).
Key exclusion criteria (8 listed)
- Pregnancy, and lactation within 24 weeks of study commencement
- Untreated cardiovascular or renal disease
- Type 1 diabetes
- Any condition associated with exercise intolerance.
- Habitual eating window < 12 hours
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 |
|---|---|---|
| High-Intensity Interval TrainingThree weekly, supervised exercise sessions with high intensity. Each session will last for 45 minutes. The intervention period will be sixteen weeks. | Behavioural | High Intensity Interval Training & Time-Restricted Eating, High-Intensity Interval Training |
| Experimental: Time-Restricted EatingRestricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks. | Behavioural | High Intensity Interval Training & Time-Restricted Eating, Time-Restricted Eating |
Primary outcome
Metabolic Syndrome Z score
Time frame: Baseline and after 16 weeks of intervention
MetS z score will be used to assess the continuous rather than dichotomous (have/not haveMetS) evolution of each MetS component into a compound score. We will calculate the Z score as the difference between the subjects and the threshold value divided by the group standard deviations for each MetS criterion.
8 secondary outcomes
Blood lipids profile
Time frame: Baseline and after 16 weeks of intervention
Glycemia
Time frame: Baseline and after 16 weeks of intervention
Blood pressure
Time frame: Baseline and after 16 weeks of intervention
Central obesity
Time frame: Baseline and after 16 weeks of intervention
Body composition
Time frame: Baseline and after 16 weeks of intervention
Insulin
Time frame: Baseline and after 16 weeks of intervention
Insulin sensitivity
Time frame: Baseline and after 16 weeks of intervention
Cardiorespiratory fitness
Time frame: Baseline and after 16 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training and Experimental: Time-Restricted Eating in people with Metabolic Syndrome and Exercise, run by University of Castilla-La Mancha at 1 site in Spain.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 8 May 2026. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome Z score (time frame: Baseline and after 16 weeks of intervention). 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 8 May 2026.