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Search / Trial NCT06501001

Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)

Launched by UNIVERSITY OF CASTILLA-LA MANCHA · Jul 8, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Metabolic Syndrome Hiit Exercise Training Time Restricted Eating

ClinConnect Summary

This clinical trial is exploring how two different approaches—time-restricted eating (TRE) and high-intensity interval training (HIIT)—can improve health for people with metabolic syndrome (MetS). MetS is a collection of conditions that increase the risk of heart disease and diabetes, such as being overweight, high blood pressure, and high blood sugar. The study will last for 16 weeks and will look at how these methods affect weight, body composition, and overall fitness. Participants will be divided into groups to either do HIIT, practice TRE, combine both, or serve as a control group without any interventions.

To be eligible for this trial, participants should be between 18 and 65 years old and diagnosed with metabolic syndrome based on specific health criteria, like having a larger waist size or elevated blood pressure. Individuals who have certain health conditions, are pregnant, or are already highly active may not qualify. Those who join can expect to have their health measured before and after the study to see how these interventions impact their metabolic health. This research aims to provide clearer insights into how these lifestyle changes can help improve health outcomes for people struggling with MetS.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

About University Of Castilla La Mancha

The University of Castilla-La Mancha is a prominent academic institution dedicated to advancing research and innovation in various fields, including health sciences. With a commitment to fostering interdisciplinary collaboration, the university engages in groundbreaking clinical trials aimed at improving patient outcomes and enhancing healthcare practices. Its research initiatives are supported by a robust network of experts and cutting-edge facilities, positioning the university as a leading sponsor in clinical research within the region. Through its rigorous ethical standards and dedication to scientific excellence, the University of Castilla-La Mancha strives to contribute significantly to the global body of medical knowledge.

Locations

Toledo, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported