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

NCT06501001 | Active Not Recruiting DMC

• 1 other identifier: TRE-HIIT-METS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metabolic syndrome; HIIT; Exercise training; Time restricted eating

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 16 weeks of intervention

Secondary Outcomes (8)

• Blood lipids profile

  Baseline and after 16 weeks of intervention

• Glycemia

  Baseline and after 16 weeks of intervention

• Blood pressure

  Baseline and after 16 weeks of intervention

• Central obesity

  Baseline and after 16 weeks of intervention

• Body composition

  Baseline and after 16 weeks of intervention

Other Outcomes (7)

• Diet intake

  Baseline and week 8 of intervention

• Daily physical activity

  Baseline and week 8 of intervention

• Sleep

  Baseline and week 8 of intervention

Study Arms (4)

High-Intensity Interval Training

EXPERIMENTAL

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

Behavioral: High-Intensity Interval Training

Time-Restricted Eating

EXPERIMENTAL

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

Behavioral: Experimental: Time-Restricted Eating

High Intensity Interval Training & Time-Restricted Eating

EXPERIMENTAL

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

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

Control

NO INTERVENTION

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

Interventions

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.

High Intensity Interval Training & Time-Restricted Eating; High-Intensity Interval Training

Experimental: Time-Restricted Eating BEHAVIORAL

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

High Intensity Interval Training & Time-Restricted Eating; Time-Restricted Eating

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla La Mancha

Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Metabolic Syndrome; Motor Activity; Weight Loss; Obesity; Intermittent Fasting

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Fasting; Feeding Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

ES (1)