Skip to main content
OpenTrials
Completed

NCT Number: NCT06501001

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Behavior Body Weight Body Weight Changes Cardiometabolic Syndrome Exercise Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Intermittent Fasting Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Time Restricted Eating Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Castilla La Mancha

Toledo, 45071, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity interval training

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

Behavioral

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

Primary outcomes

  1. Metabolic Syndrome Z score

    Time frame: Baseline and after 16 weeks of intervention

    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.

Secondary outcomes

  1. Blood lipids profile

    Time frame: Baseline and after 16 weeks of intervention

    Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting

  2. Glycemia

    Time frame: Baseline and after 16 weeks of intervention

    Serum concentrations of glycemia (in mg per dL) after 8-hour fasting

  3. Blood pressure

    Time frame: Baseline and after 16 weeks of intervention

    Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.

  4. Central obesity

    Time frame: Baseline and after 16 weeks of intervention

    Measure waist circumference (cm) in a horizontal plane, midway between the ribs' inferior margin and the iliac crest's superior border.

  5. Body composition

    Time frame: Baseline and after 16 weeks of intervention

    Measurement of the mass of man body compartments (i.e., VAT [visceral adipose tissue] fat mass, fat-free mass, and bone mass) by dual-energy x-ray absorptiometry.

  6. Insulin

    Time frame: Baseline and after 16 weeks of intervention

    Serum concentrations of insulin after 8-hour fasting

  7. Insulin sensitivity

    Time frame: Baseline and after 16 weeks of intervention

    Insulin sensitivity estimated by homeostatic model assessment for insulin resistance (fasting serum insulin concentration (μU/mL) x fasting plasma glucose levels (mmol/L)/22.5)

  8. Cardiorespiratory fitness

    Time frame: Baseline and after 16 weeks of intervention

    Maximum oxygen uptake from a graded exercise test plus a verification test

Other outcomes

  1. Diet intake

    Time frame: Baseline and week 8 of intervention

    Food diary

  2. Daily physical activity

    Time frame: Baseline and week 8 of intervention

    Measurement of daily steps using pedometers

  3. Sleep

    Time frame: Baseline and week 8 of intervention

    Measure by activity monitor

  4. Adherence to high intensity interval training

    Time frame: Week 16

    Number of completed exercise sessions out of those prescribed, in percentage

  5. Compliance to high intensity interval training

    Time frame: Week 16

    Exercise intensity, heart rate in percentage of individual heart rate maximum

  6. Compliance to time-restricted eating

    Time frame: Week 16

    Average daily eating window, in hours

  7. Adherence to time-restricted eating

    Time frame: Week 16

    Average number of days where per week that daily eating window is 10 hours or less.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Registry information

Official study title

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

Acronym: TRE-HIIT-METS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.