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

University of Castilla-La Mancha

Status: Enrolling

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

Treatments: Behavioral: High-Intensity Interval Training; Behavioral: Experimental: Time-Restricted Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06501001

TRE-HIIT-METS

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

High-Intensity Interval Training

Experimental group

Description:

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

Treatment:

Behavioral: High-Intensity Interval Training

Time-Restricted Eating

Experimental group

Description:

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

Treatment:

Behavioral: Experimental: Time-Restricted Eating

High Intensity Interval Training & Time-Restricted Eating

Experimental group

Description:

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

Treatment:

Behavioral: Experimental: Time-Restricted Eating

Behavioral: High-Intensity Interval Training

Control

No Intervention group

Description:

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