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

Not Applicable

Recruiting

• Conditions: Cardiometabolic Syndrome; Time Restricted Eating; Metabolic Syndrome; Obesity; Exercise; Weight Loss
• Interventions: Behavioral: High-Intensity Interval Training

• Registration Number: NCT06501001
• Lead Sponsor: University of Castilla-La Mancha

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-04
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Intensity Interval Training	High-Intensity Interval Training	High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.
High Intensity Interval Training & Time-Restricted Eating	High-Intensity Interval Training	High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions. Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours

Primary Outcome Measures

Name	Time	Method
Metabolic Syndrome Z score	Baseline and after 16 weeks of intervention	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.

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity	Baseline and after 16 weeks of intervention	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)
Cardiorespiratory fitness	Baseline and after 16 weeks of intervention	Maximum oxygen uptake from a graded exercise test plus a verification test
Central obesity	Baseline and after 16 weeks of intervention	Measure waist circumference (cm) in a horizontal plane, midway between the ribs' inferior margin and the iliac crest's superior border.
Body composition	Baseline and after 16 weeks of intervention	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.
Insulin	Baseline and after 16 weeks of intervention	Serum concentrations of insulin after 8-hour fasting
Blood lipids profile	Baseline and after 16 weeks of intervention	Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting
Glycemia	Baseline and after 16 weeks of intervention	Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
Blood pressure	Baseline and after 16 weeks of intervention	Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.

Trial Locations

Locations (1)

University of Castilla La Mancha; 🇪🇸 Toledo, Spain