Metabolic HealthNCT07719296
HIIT, Cardiorespiratory Fitness, and Metabolic Health in Healthy Young Adults
A study testing High-intensity interval training (HIIT) program in people with Metabolic Health and Cardio Respiratory Fitness, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health, Cardio Respiratory Fitness
- What is being tested?
- High-intensity interval training (HIIT) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2025to 16 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male university students at the High Institute of Sport and Physical Education, Kef, Tunisia.
- Aged 19 to 25 years
- Provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Metabolic Health, Cardio Respiratory Fitness
- Being tested
- High-intensity interval training (HIIT) program
- Keywords
- Training period, Aerobic fitness, Young adults, Insulin resistance, Lipid profile, Cardiometabolic health
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training (HIIT) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High-intensity interval training (HIIT) program |
| Control group | No intervention | The participants in the control group maintained their normal daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Secondary outcomes (4)
Fasting glucose
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.
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Insulin
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).
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
High-density lipoprotein cholesterol
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.
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol, expressed in mg/dL, was calculated using the Friedewald formula (Friedewald et al., 1972).
Measured: One day before the start and two days after the completion of the 09 weeks of training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Dec 2025
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Institute of Sports and Physical Education of Kef
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nejmeddine Ouerghi, High Institute of Sports and Physical Education of Kef
- Investigators
- Nejmeddine Ouerghi, Ph.D, Principal investigator, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719296
- Sponsor's protocol ID
- HIIT-MET-STUDENTS
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Training Improves Cardiorespiratory Fitness and Modestly Enhances Metabolic Health in Healthy Young Adults : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07719296
- Acronym / sponsor ID
- HIIT-MET-STUDENTS
- Conditions
- Metabolic Health, Cardio Respiratory Fitness
- Keywords
- Training period, Aerobic fitness, Young adults, Insulin resistance, Lipid profile, Cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- High Institute of Sports and Physical Education of KefUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIIT) group | Experimental | Behavioral: High-intensity interval training (HIIT) programThe 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. |
| Control group | No intervention | –The participants in the control group maintained their normal daily activities. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male university students at the High Institute of Sport and Physical Education, Kef, Tunisia.
- Aged 19 to 25 years
- Provided written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training (HIIT) programThe 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. | Behavioural | High-intensity interval training (HIIT) group |
Primary outcome
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).
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.
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.
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).
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.
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 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.
Body fat percentage
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
Body fat percentage (%) was estimated from four skinfold measurements (bicipital, triceps, subscapular, and suprailiac) using the Durnin and Womersley (1973) method.
4 secondary outcomes
Fasting glucose
Time frame: 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.
High-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
Time frame: One day before the start and two days after the completion of the 09 weeks of training program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Metabolic Health
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nejmeddine Ouerghi, Ph.D principal investigator
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training (HIIT) program in people with Metabolic Health and Cardio Respiratory Fitness, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: One day before the start and two days after the completion of the 09 weeks of training program.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.