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NCT Number: NCT07283406

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

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.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitario de Tlajomulco, Universidad de Guadalajara

Guadalajara, Jalisco, 45650, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

high-intensity interval training intervention

Other

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

Moderate-intensity continuous training intervention

Other

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).

Educational sessions

Other

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.

Primary outcomes

  1. 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

  2. Weight

    Time frame: Baseline and after 12 weeks

    Weight (kg): Changes in weight from baseline to 12 weeks of intervention.

  3. Height

    Time frame: Baseline and after 12 weeks

    Height (cm): Changes in height from baseline to 12 weeks of intervention.

  4. 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)

  5. Body fat percentage

    Time frame: Baseline and after 12 weeks

    Body fat percentage (%): Changes in body fat assessed by bioelectrical impedance analysis (BIA)

  6. Muscle mass percentage

    Time frame: Baseline and after 12 weeks

    Muscle mass percentage (%): Changes in muscle mass measured using bioelectrical impedance analysis (BIA)

  7. 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)

  8. 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

  9. Glucose

    Time frame: Baseline and after 12 weeks

    Glucose (mg/dl): Changes from baseline to 12 weeks of intervention

  10. Triglycerides

    Time frame: Baseline and after 12 weeks

    Triglycerides (mg/dl): Changes from baseline to 12 weeks of intervention

  11. Total cholesterol

    Time frame: Baseline and after 12 weeks

    Total cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention

  12. HDL cholesterol

    Time frame: Baseline and after 12 weeks

    HDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention

  13. LDL cholesterol

    Time frame: Baseline and after 12 weeks

    LDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention

  14. C-reactive protein (CRP)

    Time frame: Baseline and after 12 weeks

    CRP (mg/dl): Changes from baseline to 12 weeks of intervention

  15. Systolic blood pressure (SBP)

    Time frame: Baseline and after 12 weeks

    SBP (mmHg): Changes from baseline to 12 weeks of intervention

  16. Diastolic blood pressure (DBP)

    Time frame: Baseline and after 12 weeks

    DBP (mmHg): Changes from baseline to 12 weeks of intervention

Sponsors and collaborators

Lead sponsor

Centro Universitario de Tlajomulco, Universidad de Guadalajara

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

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.

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