- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07719296
HIIT, Cardiorespiratory Fitness, and Metabolic Health in Healthy Young Adults
July 17, 2026 updated by: Nejmeddine Ouerghi, High Institute of Sports and Physical Education of Kef
High-intensity Interval Training Improves Cardiorespiratory Fitness and Modestly Enhances Metabolic Health in Healthy Young Adults : a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
High-intensity interval training (HIIT) is a time-efficient exercise strategy for improving physical fitness.
However, limited evidence is available regarding its effects on cardiometabolic health, including blood pressure, blood lipid profile, glucose metabolism, and insulin resistance, in healthy young adults.
The purpose of this randomized controlled trial was to investigate the effects of a 9-week HIIT intervention on cardiorespiratory fitness (CRF), blood pressure, blood lipid profile, glucose, insulin, and insulin resistance estimated using the homeostasis model assessment of insulin resistance (HOMA-IR) in physically active male university students.
Twenty-nine healthy male students at the High Institute of Sport and Physical Education of Kef (Tunisia) were randomly assigned to either the HIIT group (HIITG, n=15) or the control group (CG, n=14).
The HIIT group completed a supervised training program consisting 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.
Outcome assessments were performed before and after the intervention.
Cardiorespiratory fitness was evaluated by maximal oxygen consumption (VO₂max) and maximal aerobic speed (MAS) using the Vameval incremental running test.
Cardiometabolic outcomes included systolic and diastolic blood pressure, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting glucose, fasting insulin, and insulin resistance estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).
Study Type
Interventional
Enrollment (Actual)
29
Phase
- 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
-
-
Boulifa
-
El Kef, Boulifa, Tunisia, 7100
- Tunisia
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male university students at the High Institute of Sport and Physical Education, Kef, Tunisia.
- Aged 19 to 25 years
- Provided written informed consent
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The participants in the control group maintained their normal daily activities.
|
|
|
Experimental: High-intensity interval training (HIIT) group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin resistance
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program.
|
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
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program.
|
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
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program.
|
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
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program
|
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
|
|
Body mass index
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program
|
Body mass index (BMI), expressed in kg/m², was calculated using the following formula: BMI = body mass (kg) / height² (m²).
|
One day before the start and two days after the completion of the 09 weeks of training program
|
|
Cardiorespiratory fitness
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting glucose
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program.
|
Fasting glucose 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.
|
|
Insulin
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program.
|
Insulin concentration, expressed in µU/mL, was measured by chemiluminescence immunoassay using a Liaison analyzer and the respective reagents kit (DiaSorin Inc., Stillwater, MN, USA).
|
One day before the start and two days after the completion of the 09 weeks of training program.
|
|
High-density lipoprotein cholesterol
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program.
|
High-density lipoprotein cholesterol, 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.
|
|
Low-density lipoprotein cholesterol
Time Frame: One day before the start and two days after the completion of the 09 weeks of training program
|
Low-density lipoprotein cholesterol, expressed in mg/dL, was calculated using the Friedewald formula (Friedewald et al., 1972).
|
One day before the start and two days after the completion of the 09 weeks of training program
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: 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.
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 (Actual)
December 1, 2025
Primary Completion (Actual)
February 16, 2026
Study Completion (Actual)
February 16, 2026
Study Registration Dates
First Submitted
July 17, 2026
First Submitted That Met QC Criteria
July 17, 2026
First Posted (Actual)
July 22, 2026
Study Record Updates
Last Update Posted (Actual)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Glucose Metabolism Disorders
- Hyperinsulinism
- Nutritional and Metabolic Diseases
- Insulin Resistance
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Conditioning, Human
- Exercise
- High-Intensity Interval Training
Other Study ID Numbers
- HIIT-MET-STUDENTS
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.
Clinical Trials on Metabolic Health
-
UMC UtrechtCompletedCardiovascular Health | Metabolic Health | Pulmonary HealthNetherlands
-
One Bio Inc.People Science, Inc.CompletedMetabolic Health | Digestive HealthUnited States
-
University of AberdeenMedical Research Council; University of LiverpoolCompletedGut Health | Metabolic HealthUnited Kingdom
-
Instituto Politécnico da GuardaCompleted
-
AdventHealth Translational Research InstituteCompletedMetabolic HealthUnited States
-
University of California, San FranciscoCompletedMetabolic HealthUnited States
-
Daily NouriRecruiting
-
ViomeRecruitingMetabolic HealthUnited States
-
Nature's Sunshine Products, Inc.Completed
-
University of NottinghamCompletedMetabolic HealthUnited Kingdom
Clinical Trials on High-intensity interval training (HIIT) program
-
University of ÉvoraCompletedPatients With Coronary Artery DiseasePortugal
-
Université de SherbrookeRecruiting
-
Wroclaw University of Health and Sport SciencesActive, not recruitingPhysical Activity | Blood Pressure | Cardiorespiratory Fitness | Adipose Tissue | AdolescentsPoland
-
Mayo ClinicActive, not recruitingCardiac RehabilitationUnited States
-
Karolinska University HospitalKarolinska InstitutetUnknownDermatomyositis | PolymyositisSweden
-
Wu JiarunCompletedBurnout,Motivation,Stress,Mental ToughnessMalaysia
-
McMaster UniversityCompleted
-
Chang Gung Memorial HospitalCompletedHeart Failure | Morality | Remodeling, VentricularTaiwan
-
Brock UniversityCompletedCardiovascular Diseases | Metabolic SyndromeCanada
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedKnee OsteoarthritisUnited States