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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Spain
University of Castilla La Mancha
RECRUITING
Toledo
Contact Information
Primary
Felix Morales Palomo, PhD
felix.morales@uclm.es
925268800
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 200
Treatments
Experimental: High-Intensity Interval Training
High-intensity interval training for sixteen weeks. Three weekly, supervised training sessions.
Experimental: Time-Restricted Eating
Time-restricted eating for sixteen weeks. Maximal daily eating window of 10 hours
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
No_intervention: Control
Information about the recommended level of physical activity for health benefits and a healthy diet will be given.
Related Therapeutic Areas
Sponsors
Leads: University of Castilla-La Mancha

This content was sourced from clinicaltrials.gov