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

NCT ID: NCT06501001

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-02-28

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.

Conditions

Metabolic Syndrome; Exercise; Weight Loss; Obesity; Cardiometabolic Syndrome; Time Restricted Eating

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High-Intensity Interval Training

High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.

Group Type: EXPERIMENTAL

High-Intensity Interval Training

Intervention Type: BEHAVIORAL

Three weekly, supervised exercise sessions with high intensity. Each session will last for 45 minutes. The intervention period will be sixteen weeks.

Time-Restricted Eating

Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours

Group Type: EXPERIMENTAL

Experimental: Time-Restricted Eating

Intervention Type: BEHAVIORAL

Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.

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

Group Type: EXPERIMENTAL

High-Intensity Interval Training

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.

Control

Information about the recommended level of physical activity for health benefits and a healthy diet will be given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Experimental: Time-Restricted Eating

Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Felix Morales Palomo

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Castilla La Mancha

Toledo, , Spain

Countries

Spain

Other Identifiers

TRE-HIIT-METS

Identifier Type: -

Identifier Source: org_study_id