NCT07719296

Brief Summary

The purpose of this study was to investigate the effects of a high-intensity interval training (HIIT) intervention on cardiorespiratory fitness (CRF) and cardiometabolic health in active male university students. The main question it aims to answer is: Does HIIT improves CRF and cardiometabolic outcomes, including blood pressure, lipid profile, and insulin resistance estimated using the homeostasis model assessment of insulin resistance (HOMA-IR). Researchers will compare HIIT (designed to experimental group) to non-training intervention (designed to control group) to see if the training program works to improve the cardiometabolic health status. The HIIT program consisted of three sessions per week for 9 weeks, comprising of three sets of six to eight 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% MAS between bouts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 17, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Training periodAerobic fitnessYoung adultsInsulin resistanceLipid profileCardiometabolic health

Outcome Measures

Primary Outcomes (7)

  • Insulin resistance

    Insulin resistance was estimated by the homeostasis model assessment (HOMA-IR) index as HOMA-IR = (fasting insulin (mU/l) × fasting glucose (mmol/l) / 22.5)) (Matthews et al., 1985).

    One day before the start and two days after the completion of the 09 weeks of training program.

  • Total cholesterol

    Total cholesterol concentration, expressed in mg/dL, was assessed by the enzymatic method on an Architect C8000 auto analyzer (Abbott Laboratories, Abbott Park, IL) using respective reagent kits.

    One day before the start and two days after the completion of the 09 weeks of training program.

  • Triglyceride

    Triglyceride concentration, expressed in mg/dL, was assessed by the enzymatic method on an Architect C8000 auto analyzer (Abbott Laboratories, Abbott Park, IL) using respective reagent kits.

    One day before the start and two days after the completion of the 09 weeks of training program.

  • Blood pressure

    Blood pressure, expressed in mmHg, was measured after 15 minutes of seated rest using an automatic blood pressure monitor (Omron BP652; Omron Healthcare Inc., Vernon Hills, IL, USA).

    One day before the start and two days after the completion of the 09 weeks of training program

  • Cardiorespiratory fitness

    Cardiorespiratory fitness was assessed using the Vameval incremental running test performed to exhaustion (Cazorla, 1999). Maximal aerobic speed (MAS) was determined from the highest running speed achieved during the test, and maximal oxygen consumption (VO2max) was estimated using the standard Vameval protocol (Cazorla, 1999). The Vameval test is a validated field test for assessing aerobic capacity in healthy young adults.

    One day before the start and two days after the completion of the 09 weeks of training program.

  • Body mass index

    Body mass index (BMI), expressed in kg/m², was calculated from measured body mass (kg) and height (m) using the standard formula: BMI = body mass (kg) / height² (m²). Body mass and height were used only to derive BMI and were not considered separate outcome measures.

    One day before the start and two days after the completion of the 09 weeks of training program

  • Body fat percentage

    Body fat percentage (%) was estimated from four skinfold measurements (bicipital, triceps, subscapular, and suprailiac) using the Durnin and Womersley (1973) method.

    One day before the start and two days after the completion of the 09 weeks of training program.

Secondary Outcomes (4)

  • Fasting glucose

    One day before the start and two days after the completion of the 09 weeks of training program.

  • Insulin

    One day before the start and two days after the completion of the 09 weeks of training program.

  • High-density lipoprotein cholesterol

    One day before the start and two days after the completion of the 09 weeks of training program.

  • Low-density lipoprotein cholesterol

    One day before the start and two days after the completion of the 09 weeks of training program

Study Arms (2)

High-intensity interval training (HIIT) group

EXPERIMENTAL

The HIIT group performed a HIIT program consisting of three sessions per week for 9 weeks, including three sets of six to eight bouts of 30-second runs at high intensity \[100-110% of maximal aerobic speed (MAS)\], interspersed with 30-second recovery runs at low intensity (50% MAS) between bouts, in line with recommendations by Ouerghi et al. (2017, 2026) in young males.

Behavioral: High-intensity interval training (HIIT) program

Control group

NO INTERVENTION

The participants in the control group maintained their normal daily activities.

Interventions

The HIIT program consisted of three sessions per week for 9 weeks, comprising of three sets of sixr to eight bouts of 30-second runs at high intensity \[100-110% of maximal aerobic speed (MAS)\], interspersed with 30-second recovery runs at low intensity (50% MAS) between bouts.

High-intensity interval training (HIIT) group

Eligibility Criteria

Age19 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male university students at the High Institute of Sport and Physical Education, Kef, Tunisia.
  • Aged 19 to 25 years
  • Provided written informed consent

You may not qualify if:

  • Acute or chronic disease contraindicating vigorous physical exercise
  • Musculoskeletal injury or any other medical condition limiting participation in exercise
  • Participation in another structured training program within the previous 6 months
  • Current or recent (within the previous 3 months) use of medications or dietary supplements that could influence the study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunisia

El Kef, Boulifa, 7100, Tunisia

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nejmeddine Ouerghi, Ph.D

    Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 22, 2026

Study Start

December 1, 2025

Primary Completion

February 16, 2026

Study Completion

February 16, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations