Hormonal ResponseNCT07893613
Effects of Chronic Exercise on Hormonal and Mineral Biomarkers in Male University Students
A study testing High-intensity interval training program in people with Hormonal Response and Mineral Metabolism, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
Trial summary
The purpose of this study is to investigate the effects of a high-intensity interval training (HIIT) program on hormonal and mineral biomarkers and aerobic fitness in 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
- Hormonal Response, Mineral Metabolism, Exercise Training
- What is being tested?
- High-intensity interval training 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 18 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
- Aged 19-25 years.
- Male university students enrolled at the High Institute of Sport and Physical Education of Kef, Tunisia.
- Provided written informed consent.
- Willing to maintain usual daily routines, habitual physical activity, and dietary habits throughout the 9-week study period.
Who cannot join
- Presence of an acute or chronic illness.
- Any medical condition contraindicating vigorous exercise.
- Participation in another structured training program within the previous 6 months.
- Use of medications or dietary supplements within the previous 3 months.
- Following a restrictive diet within the previous 3 months.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
High Institute of Sport and Physical Education of Kef, University of Jendouba Kef, Boulifa, Tunisia, 7100
El Kef, Boulifa, 7100
About this study
Official title: Effects of a Physical Exercise Training Program on Hormonal and Mineral Biomarkers and Aerobic Fitness in Male University Students: A Randomized Controlled Trial
The purpose of this study is to investigate the effects of a high-intensity interval training (HIIT) program on hormonal and mineral biomarkers and aerobic fitness in male university students. The study aims to determine whether HIIT improves hormonal biomarkers, including testosterone, cortisol, the testosterone-to-cortisol ratio, and growth hormone (GH), as well as mineral metabolism biomarkers, including parathyroid hormone (PTH), 25-hydroxyvitamin D [25(OH)D], calcium, and phosphate. Participants will be assigned to either a HIIT group or a non-training control group. The HIIT group completed three sessions per week for 9 weeks, alternating 30-second runs at high-intensity and low-intensity. The control group did not participate in the training intervention and maintained its usual daily activities.
Read the detailed description
Chronic exercise, particularly high-intensity interval training (HIIT), is a time-efficient training strategy that may improve cardiorespiratory fitness. However, its effects on resting hormonal biomarkers and mineral metabolism remain insufficiently characterized in male university students. The purpose of this randomized controlled trial was to investigate the effects of a 9-week HIIT program on hormonal biomarkers, mineral metabolism, and aerobic fitness in male university students. The hormonal biomarkers assessed included testosterone, cortisol, the testosterone-to-cortisol ratio, and growth hormone (GH). Mineral metabolism was evaluated by measuring circulating parathyroid hormone (PTH), 25-hydroxyvitamin D [25(OH)D], calcium, and phosphate concentrations. Aerobic fitness was assessed using maximal aerobic speed (MAS) and maximal oxygen uptake (VO2max). Participants were allocated to either an experimental HIIT group or a non-training control group. The HIIT intervention consisted of three sessions per week for 9 weeks. Each session comprised three sets of 6-8 repetitions of 30-second running bouts performed at 100-110% of MAS, interspersed with 30-second active recovery runs at 50% of MAS. The control group did not participate in the HIIT intervention and maintained its usual daily activities. Study outcomes were evaluated before and after the intervention to determine changes in hormonal biomarkers, mineral metabolism, and aerobic fitness.
- Conditions
- Hormonal Response, Mineral Metabolism, Exercise Training
- Being tested
- High-intensity interval training program
- Keywords
- Chronic exercise, Testosterone-to-Cortisol Ratio, Growth Hormone, 25-Hydroxyvitamin D, Parathyroid Hormone, Mineral Metabolism, Maximal Aerobic Speed, University Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training programBehavioural
The high-intensity interval training program consisted of three sessions per week for 9 weeks. Each session comprised three sets of 6-8 repetitions of 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% of MAS between bouts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group completed a high-intensity interval training (HIIT) program consisting of three sessions per week for 9 weeks. Each session comprised three sets of 6-8 repetitions of 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% of MAS. Receives: Behavioral: High-intensity interval training program |
| Control group | No intervention | Participants in the control group maintained their usual daily activities and did not participate in the HIIT intervention throughout the 9-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone
Testosterone concentration, expressed in µg/dL, was measured using enzyme-linked immunosorbent assay (ELISA) kits (Monobind, Inc., Lake Forest, CA).
Measured: One day before the start and two days after the completion of the 09 weeks of training program
Cortisol
Cortisol concentration, expressed in µg/dL, was measured using an automated chemiluminescence immunoassay (DiaSorin Inc., Stillwater, MN).
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Testosterone/cortisol ratio
Testosterone/cortisol ratio (T/C) was calculated by dividing the testosterone value by the cortisol value for each participant.
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Parathyroid Hormone
Parathyroid hormone concentration, expressed in pg/mL, was measured using an automated chemiluminescence immunoassay (DiaSorin Inc., Stillwater, MN).
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Growth hormone
Growth hormone concentration, expressed in mIU/L, was measured using an immunoradiometric assay (IRMA GH; Beckman Coulter).
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
25-hydroxyvitamin D
25-hydroxyvitamin D [25(OH)D] concentration, expressed in ng/mL, was analyzed using an automated chemiluminescence immunoassay (DiaSorin Inc., Stillwater, MN).
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Aerobic capacity
Aerobic capacity was assessed using the Vameval incremental running test performed to exhaustion (Cazorla, 1999). Maximal aerobic speed (MAS), expressed in km/h, was determined from the highest running speed achieved during the test, and maximal oxygen uptake (VO₂max), expressed in mL·kg-¹·min-¹, was estimated using the Vameval protocol (Cazorla, 1999).
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Secondary outcomes (2)
Calcium
Calcium concentration, expressed in mg/L, was assessed on Architect C8000 analyzer (Abbott Laboratories, Abbott Park, IL), using the respective reagents kits.
Measured: One day before the start and two days after the completion of the 09 weeks of training program.
Phosphorus
Phosphorus concentration, expressed in mg/L, was assessed on Architect C8000 analyzer (Abbott Laboratories, Abbott Park, IL), using the respective reagents kits.
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 posted26 Oct 2026
- Study start1 Dec 2025
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormonal ResponseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- 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
- NCT07893613
- Sponsor's protocol ID
- Exercise-Hormone-Males
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Exercise Training Program on Hormonal and Mineral Biomarkers and Aerobic Fitness in Male University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07893613
- Acronym / sponsor ID
- Exercise-Hormone-Males
- Conditions
- Hormonal Response, Mineral Metabolism, Exercise Training
- Keywords
- Chronic exercise, Testosterone-to-Cortisol Ratio, Growth Hormone, 25-Hydroxyvitamin D, Parathyroid Hormone, Mineral Metabolism, Maximal Aerobic Speed, University Students
- 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
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 26 Oct 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 is to investigate the effects of a high-intensity interval training (HIIT) program on hormonal and mineral biomarkers and aerobic fitness in male university students. The study aims to determine whether HIIT improves hormonal biomarkers, including testosterone, cortisol, the testosterone-to-cortisol ratio, and growth hormone (GH), as well as mineral metabolism biomarkers, including parathyroid hormone (PTH), 25-hydroxyvitamin D [25(OH)D], calcium, and phosphate. Participants will be assigned to either a HIIT group or a non-training control group. The HIIT group completed three sessions per week for 9 weeks, alternating 30-second runs at high-intensity and low-intensity. The control group did not participate in the training intervention and maintained its usual daily activities.
Detailed description
Chronic exercise, particularly high-intensity interval training (HIIT), is a time-efficient training strategy that may improve cardiorespiratory fitness. However, its effects on resting hormonal biomarkers and mineral metabolism remain insufficiently characterized in male university students. The purpose of this randomized controlled trial was to investigate the effects of a 9-week HIIT program on hormonal biomarkers, mineral metabolism, and aerobic fitness in male university students. The hormonal biomarkers assessed included testosterone, cortisol, the testosterone-to-cortisol ratio, and growth hormone (GH). Mineral metabolism was evaluated by measuring circulating parathyroid hormone (PTH), 25-hydroxyvitamin D [25(OH)D], calcium, and phosphate concentrations. Aerobic fitness was assessed using maximal aerobic speed (MAS) and maximal oxygen uptake (VO2max). Participants were allocated to either an experimental HIIT group or a non-training control group. The HIIT intervention consisted of three sessions per week for 9 weeks. Each session comprised three sets of 6-8 repetitions of 30-second running bouts performed at 100-110% of MAS, interspersed with 30-second active recovery runs at 50% of MAS. The control group did not participate in the HIIT intervention and maintained its usual daily activities. Study outcomes were evaluated before and after the intervention to determine changes in hormonal biomarkers, mineral metabolism, and aerobic fitness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: High-intensity interval training programParticipants in the intervention group completed a high-intensity interval training (HIIT) program consisting of three sessions per week for 9 weeks. Each session comprised three sets of 6-8 repetitions of 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% of MAS. |
| Control group | No intervention | –Participants in the control group maintained their usual daily activities and did not participate in the HIIT intervention throughout the 9-week study period. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 19-25 years.
- Male university students enrolled at the High Institute of Sport and Physical Education of Kef, Tunisia.
- Provided written informed consent.
- Willing to maintain usual daily routines, habitual physical activity, and dietary habits throughout the 9-week study period.
Key exclusion criteria (5 listed)
- Presence of an acute or chronic illness.
- Any medical condition contraindicating vigorous exercise.
- Participation in another structured training program within the previous 6 months.
- Use of medications or dietary supplements within the previous 3 months.
- Following a restrictive diet within the previous 3 months.
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 programThe high-intensity interval training program consisted of three sessions per week for 9 weeks. Each session comprised three sets of 6-8 repetitions of 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% of MAS between bouts. | Behavioural | Intervention group |
Primary outcome
Testosterone
Time frame: One day before the start and two days after the completion of the 09 weeks of training program
Testosterone concentration, expressed in µg/dL, was measured using enzyme-linked immunosorbent assay (ELISA) kits (Monobind, Inc., Lake Forest, CA).
Cortisol
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
Cortisol concentration, expressed in µg/dL, was measured using an automated chemiluminescence immunoassay (DiaSorin Inc., Stillwater, MN).
Testosterone/cortisol ratio
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
Testosterone/cortisol ratio (T/C) was calculated by dividing the testosterone value by the cortisol value for each participant.
Parathyroid Hormone
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
Parathyroid hormone concentration, expressed in pg/mL, was measured using an automated chemiluminescence immunoassay (DiaSorin Inc., Stillwater, MN).
Growth hormone
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
Growth hormone concentration, expressed in mIU/L, was measured using an immunoradiometric assay (IRMA GH; Beckman Coulter).
25-hydroxyvitamin D
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
25-hydroxyvitamin D [25(OH)D] concentration, expressed in ng/mL, was analyzed using an automated chemiluminescence immunoassay (DiaSorin Inc., Stillwater, MN).
Aerobic capacity
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
Aerobic capacity was assessed using the Vameval incremental running test performed to exhaustion (Cazorla, 1999). Maximal aerobic speed (MAS), expressed in km/h, was determined from the highest running speed achieved during the test, and maximal oxygen uptake (VO₂max), expressed in mL·kg-¹·min-¹, was estimated using the Vameval protocol (Cazorla, 1999).
2 secondary outcomes
Calcium
Time frame: One day before the start and two days after the completion of the 09 weeks of training program.
Phosphorus
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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 program in people with Hormonal Response and Mineral Metabolism, 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 4 inclusion and 5 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 26 Oct 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?
Testosterone (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 26 Oct 2026.