Combining time-restricted eating and high-intensity interval training to improve health in metabolic syndrome patients
Time Restricted Eating and High-Intensity Interval Training to Improve Health in Patients With Metabolic Syndrome
This study is testing if combining time-restricted eating with high-intensity interval training can help people with metabolic syndrome improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Castilla-La Mancha Academic / other |
| Locations | 1 site (Toledo) |
| Trial ID | NCT06501001 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-intensity interval training (HIIT) and time-restricted eating (TRE) on patients with metabolic syndrome. Over a 16-week intervention period, participants will engage in either HIIT, TRE, both, or neither, while various cardiometabolic health markers will be measured before and after the intervention. The goal is to determine how these lifestyle changes can independently and collectively improve health outcomes for overweight or obese individuals with metabolic syndrome.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults aged 18 to 65 diagnosed with metabolic syndrome.
Not a fit: Patients with untreated cardiovascular or renal diseases, type 1 diabetes, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant improvements in weight management and cardiometabolic health for patients with metabolic syndrome.
How similar studies have performed: While limited research exists on this specific combination, preliminary studies suggest potential benefits of both HIIT and TRE in improving metabolic health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toledo
- University of Castilla La Mancha — Toledo, Spain (Recruiting)
Study contacts
- Study coordinator: Ricardo Mora Rodriguez, PhD
- Email: ricardo.mora@uclm.es
- Phone: 925268800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.