Clinical trial NCT06501001: Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)
Official title: Time Restricted Eating and High-Intensity Interval Training to Improve Health in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Exercise
Weight Loss
Obesity
Cardiometabolic Syndrome
Time Restricted Eating
Keywords: Metabolic syndrome
HIIT
Exercise training
Time restricted eating
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


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

Primary outcomes:
measure: Metabolic Syndrome Z score
timeFrame: Baseline and after 16 weeks of intervention
Secondary outcomes:
measure: Blood lipids profile
timeFrame: Baseline and after 16 weeks of intervention
measure: Glycemia
timeFrame: Baseline and after 16 weeks of intervention
measure: Blood pressure
timeFrame: Baseline and after 16 weeks of intervention
measure: Central obesity
timeFrame: Baseline and after 16 weeks of intervention
measure: Body composition
timeFrame: Baseline and after 16 weeks of intervention
measure: Insulin
timeFrame: Baseline and after 16 weeks of intervention
measure: Insulin sensitivity
timeFrame: Baseline and after 16 weeks of intervention
measure: Cardiorespiratory fitness
timeFrame: Baseline and after 16 weeks of intervention
Other outcomes:
measure: Diet intake
timeFrame: Baseline and week 8 of intervention
measure: Daily physical activity
timeFrame: Baseline and week 8 of intervention
measure: Sleep
timeFrame: Baseline and week 8 of intervention
measure: Adherence to high intensity interval training
timeFrame: Week 16
measure: Compliance to high intensity interval training
timeFrame: Week 16
measure: Compliance to time-restricted eating
timeFrame: Week 16
measure: Adherence to time-restricted eating
timeFrame: Week 16
Locations:
city: Toledo
country: Spain
facility: University of Castilla La Mancha
Study officials:
References: