NCT06501001Completed
Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)
Time Restricted Eating and High-Intensity Interval Training to Improve Health in Patients With Metabolic Syndrome
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 8 Jul 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- University of Castilla-La Mancha
- Diseases
- Obesity
- NCT number
- NCT06501001
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 1 Sept 2024 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Body mass variations \> 4 kg three months prior to study commencement
Other illness
- Untreated cardiovascular or renal disease
- Type 1 diabetes
- Any condition associated with exercise intolerance.
Other
- Pregnancy, and lactation within 24 weeks of study commencement
- Habitual eating window \< 12 hours
- Performing high-intensity training more than once a week
- Shift work that includes night shifts
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Castilla-La Mancha Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.