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

N/AActive Not RecruitingNCT06501001

University of Castilla-La Mancha200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Metabolic Syndrome Exercise Weight Loss

Interventions

High-Intensity Interval TrainingBEHAVIORAL

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 EatingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.