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

Time Restricted Eating and High-Intensity Interval Training to Improve Health in Patients With Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Weight Loss; Exercise; Cardiometabolic Syndrome; Time Restricted Eating
• Intervention / Treatment: Behavioral: Experimental: Time-Restricted Eating; Behavioral: High-Intensity Interval Training

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45071
    • University of Castilla La Mancha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Intensity Interval Training; High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.	Behavioral: High-Intensity Interval Training; Three weekly, supervised exercise sessions with high intensity. Each session will last for 45 minutes. The intervention period will be sixteen weeks.
Experimental: Time-Restricted Eating; Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours	Behavioral: Experimental: Time-Restricted Eating; Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.
Experimental: High Intensity Interval Training & Time-Restricted Eating; 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	Behavioral: Experimental: Time-Restricted Eating; Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.; Behavioral: High-Intensity Interval Training; Three weekly, supervised exercise sessions with high intensity. Each session will last for 45 minutes. The intervention period will be sixteen weeks.
No Intervention: Control; Information about the recommended level of physical activity for health benefits and a healthy diet will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 27, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Exercise training; HIIT; Time restricted eating
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Obesity; Weight Loss; Metabolic Syndrome; Motor Activity; Intermittent Fasting; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human; Exercise; High-Intensity Interval Training
• Other Study ID Numbers: TRE-HIIT-METS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No