NCT06501001

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	Experimental: Time-Restricted Eating	Restricted daily window of caloric intake to a maximum 10 hours. The intervention period will be sixteen weeks.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-07-15
• Last updated: 2025-12-02

Locations

1 site across 1 country: Spain