Status:
ACTIVE_NOT_RECRUITING
Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)
Lead Sponsor:
University of Castilla-La Mancha
Conditions:
Metabolic Syndrome
Exercise
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 restric...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06501001
Start Date
September 1 2024
End Date
February 1 2026
Last Update
December 2 2025
Active Locations (1)
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1
University of Castilla La Mancha
Toledo, Spain, 45071