Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)
NCT Number: NCT06501001
Acronym: TRE-HIIT-METS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Syndrome|Exercise|Weight Loss|Obesity|Cardiometabolic Syndrome|Time Restricted Eating
Interventions: BEHAVIORAL: High-Intensity Interval Training|BEHAVIORAL: Experimental: Time-Restricted Eating|BEHAVIORAL: High Intensity Interval Training & Time-Restricted Eating
Sponsor: University of Castilla-La Mancha
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2025-06
Locations: University of Castilla La Mancha, Toledo, 45071, Spain

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.

Primary Outcome Measures: Metabolic Syndrome Z score, MetS z score will be used to assess the continuous rather than dichotomous (have/not haveMetS) evolution of each MetS component into a compound score. We will calculate the Z score as the difference between the subjects and the threshold value divided by the group standard deviations for each MetS criterion., Baseline and after 16 weeks of intervention
Secondary Outcome Measures: Blood lipids profile, Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting, Baseline and after 16 weeks of intervention|Glycemia, Serum concentrations of glycemia (in mg per dL) after 8-hour fasting, Baseline and after 16 weeks of intervention|Blood pressure, Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest., Baseline and after 16 weeks of intervention|Central obesity, Measure waist circumference (cm) in a horizontal plane, midway between the ribs' inferior margin and the iliac crest's superior border., Baseline and after 16 weeks of intervention|Body composition, Measurement of the mass of man body compartments (i.e., VAT \[visceral adipose tissue\] fat mass, fat-free mass, and bone mass) by dual-energy x-ray absorptiometry., Baseline and after 16 weeks of intervention|Insulin, Serum concentrations of insulin after 8-hour fasting, Baseline and after 16 weeks of intervention|Insulin sensitivity, Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5), Baseline and after 16 weeks of intervention|Cardiorespiratory fitness, Maximum oxygen uptake from a graded exercise test plus a verification test, Baseline and after 16 weeks of intervention
Other Outcome Measures: Diet intake, Food diary, Baseline and week 8 of intervention|Daily physical activity, Measurement of daily steps using pedometers, Baseline and week 8 of intervention|Sleep, Measure by activity monitor, Baseline and week 8 of intervention|Adherence to high intensity interval training, Number of completed exercise sessions out of those prescribed, in percentage, Week 16|Compliance to high intensity interval training, Exercise intensity, heart rate in percentage of individual heart rate maximum, Week 16|Compliance to time-restricted eating, Average daily eating window, in hours, Week 16|Adherence to time-restricted eating, Average number of days where per week that daily eating window is 10 hours or less., Week 16