Effect of High-intensity Interval Training on Cardiometabolic Health and Physical Fitness in Young Adults With Obesity

December 11, 2025 updated by: José Manuel Pérez Casillas, Centro Universitario de Tlajomulco, Universidad de Guadalajara
The objective of the present project is to compare the effects of two types of training on cardiovascular health components and physical fitness in young adults with obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity represents a serious public health problem, and its prevalence continues to rise worldwide. Numerous studies have documented the positive effects of moderate-intensity continuous training (MICT) on cardiovascular and metabolic health in individuals living with obesity; however, the effects of high-intensity interval training (HIIT) are still being explored.

Therefore, the objective of the present research protocol is to analyze and compare the effects of an MICT program and an HIIT program on cardiometabolic biomarkers and physical fitness in young adults with obesity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 45650
        • Centro Universitario de Tlajomulco, Universidad de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Young adults
  • BMI ≥ 30 kg/m^2" and < 40 kg/m^2
  • Signed informed consent form

Exclusion Criteria:

  • Participants who smoke
  • Clinical diagnosis of hypothyroidism
  • Clinical diagnosis of type 1 diabetes mellitus
  • Clinical diagnosis of type 2 diabetes mellitus
  • Clinical diagnosis of grade 3 obesity
  • Clinical diagnosis of hypertension
  • Clinical diagnosis of acute myocardial infarction or angina pectoris
  • Use of nitrates and calcium channel blockers within 4 days prior to the start of the study
  • Use of beta-blockers or hypoglycemic agents within 7 days prior to the intervention
  • Pregnant women
  • Breastfeeding women
  • Men consuming more than 40 g of alcohol per day or women consuming more than 20 g per day
  • Postural and biomechanical disorders (knee, foot, and spine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HIIT Group
This group will train for 12 weeks
Other: High-intensity interval training intervention
The HIIT group will undergo training for 12 weeks, with a frequency of three sessions per week, completing a total of 36 sessions. Each session will include a 5-minute warm-up and a 5-minute cool-down at 50-60% of maximum heart rate (HRmax). The training protocol will consist of 2-minute high-intensity intervals performed at 90-95% HRmax, corresponding to a Borg rating of perceived exertion (RPE) of 17-18, alternated with 2-minute recovery periods at 70% HRmax (RPE 12-14). A total of five intervals will be completed per session, resulting in an overall high-intensity workload of 18 minutes. All training sessions will be conducted on a stationary cycle ergometer
Other: Educational sessions
In addition, four educational sessions will be conducted to provide dietary recommendations to all participants. These sessions will aim to promote balanced eating habits and to discourage the excessive consumption of ultra-processed foods or alcohol, as these factors could interfere with the intervention outcomes.
Active Comparator: MICT Group
This group will train for 12 weeks
Other: Educational sessions
In addition, four educational sessions will be conducted to provide dietary recommendations to all participants. These sessions will aim to promote balanced eating habits and to discourage the excessive consumption of ultra-processed foods or alcohol, as these factors could interfere with the intervention outcomes.
Other: Moderate-intensity continuous training intervention
The MICT group will perform moderate-intensity continuous training at 60-70% HRmax, corresponding to an RPE of 12-14, for 35-45 minutes on a stationary cycleergometer. Heart rate and physical activity levels will be continuously monitored in both groups using a chest-strap heart rate sensor (Polar H9, Polar Electro, Finland).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum oxygen uptake (VO₂max)
Time Frame: Baseline and after 12 weeks
VO₂max (ml/min/kg): Change from Baseline at 12 weeks, measured using a submaximal exercise test based on the Åstrand-Ryhming protocol
Baseline and after 12 weeks
Weight
Time Frame: Baseline and after 12 weeks
Weight (kg): Changes in weight from baseline to 12 weeks of intervention.
Baseline and after 12 weeks
Height
Time Frame: Baseline and after 12 weeks
Height (cm): Changes in height from baseline to 12 weeks of intervention.
Baseline and after 12 weeks
Body mass index (BMI)
Time Frame: Baseline and after 12 weeks
BMI (kg/m2): Change from Baseline at 12 weeks, calculated by: weight (kg)/ height (m^2)
Baseline and after 12 weeks
Body fat percentage
Time Frame: Baseline and after 12 weeks
Body fat percentage (%): Changes in body fat assessed by bioelectrical impedance analysis (BIA)
Baseline and after 12 weeks
Muscle mass percentage
Time Frame: Baseline and after 12 weeks
Muscle mass percentage (%): Changes in muscle mass measured using bioelectrical impedance analysis (BIA)
Baseline and after 12 weeks
Waist circumference
Time Frame: Baseline and after 12 weeks
Waist circumference (cm): Changes in waist circumference will be measured using a Lufkin measuring tape (USA) following the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK)
Baseline and after 12 weeks
Waist-to-hip ratio
Time Frame: Baseline and after 12 weeks
Waist-to-hip ratio: Changes in waist-to-hip ratio will be calculated by dividing the waist measurement by the hip measurement
Baseline and after 12 weeks
Glucose
Time Frame: Baseline and after 12 weeks
Glucose (mg/dl): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks
Triglycerides
Time Frame: Baseline and after 12 weeks
Triglycerides (mg/dl): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks
Total cholesterol
Time Frame: Baseline and after 12 weeks
Total cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks
HDL cholesterol
Time Frame: Baseline and after 12 weeks
HDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks
LDL cholesterol
Time Frame: Baseline and after 12 weeks
LDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks
C-reactive protein (CRP)
Time Frame: Baseline and after 12 weeks
CRP (mg/dl): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks
Systolic blood pressure (SBP)
Time Frame: Baseline and after 12 weeks
SBP (mmHg): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks
Diastolic blood pressure (DBP)
Time Frame: Baseline and after 12 weeks
DBP (mmHg): Changes from baseline to 12 weeks of intervention
Baseline and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Universitario de Tlajomulco, Universidad de Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CUTLAJO251028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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