IrisinTIDIERNCT07191015
Temporal Dynamics of Irisin
A study testing Low-Intensity Continuous Exercise, Moderate Intensity Interval Exercise and High-Intensity Interval Exercise in people with Irisin and Lactate, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose The purpose of this study was to determine the peak point of irisin following exercises of different intensities. Method This randomized crossover controlled trial aimed to examine the acute effects of three experimental conditions-high-intensity interval training, long-interval continuous training, and… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Irisin, Lactate, Exercise Intensity
- What is being tested?
- Low-Intensity Continuous Exercise, Moderate Intensity Interval Exercise and High-Intensity Interval Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2025to 15 Sep 2025
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 25 years
- No known medical condition that prevents participation in exercise
- Not currently using any pharmacological agents
Who cannot join
- Experiencing any discomfort before, during, or after exercise
- Current or past diagnosis of pharmacological or doping substance use
- Engaging in regular exercise (more than 3 times per week) within the last 2 weeks
- History of alcohol or substance addiction
- Any other condition or factor that may prevent full participation in the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Dynamics of Irisin: Influence of Exercise Intensity on Peak Release
Purpose The purpose of this study was to determine the peak point of irisin following exercises of different intensities.
Method This randomized crossover controlled trial aimed to examine the acute effects of three experimental conditions-high-intensity interval training, long-interval continuous training, and low-intensity continuous training-on serum irisin and blood lactate levels in healthy young adults aged 18-25 years.
Read more
All participants completed the three conditions in a randomized and counterbalanced manner. To ensure balanced exposure, they were assigned to one of three groups (n = 4 per group), each following a distinct condition order based on a Latin square design. This approach guaranteed that each session occurred equally across time points (sessions 1-3) and that the order minimized sequence effects by rotating the position of each condition relative to the others.
To control for potential carryover-particularly from elevated endocrine responses following intense exercise (increases in irisin had been reported)-no two high-intensity sessions were scheduled consecutively. Where possible, higher- and lower-intensity protocols were alternated. Furthermore, a seven-day interval separated each session to reduce residual physiological or cognitive effects.
The trial protocol was developed in line with CONSORT and SPIRIT guidelines, including relevant extensions for within-subject designs and non-pharmacological interventions. Participants were blinded to the study hypothesis.
All exercise sessions were conducted in the morning (09:00-11:00) on a track and field pitch under the supervision of a certified strength and conditioning coach to ensure consistency and adherence to protocol. Participants were instructed to avoid strenuous activity for 48 hours prior, abstain from alcohol and caffeine for 24 hours, and obtain at least 7-8 hours of sleep before each session. Dietary habits and general lifestyle were kept unchanged throughout the study.
During the first visit, participants' body weight and body fat percentage were assessed using bioelectrical impedance analysis. Resting heart rate was then recorded, followed by administration of the Yo-Yo Intermittent Recovery Test Level 1 to determine maximal aerobic speed (MAS), aerobic capacity, and peak heart rate.
In the following four visits, each participant completed all experimental conditions. Each exercise session began with a standardized 10-minute warm-up, including light jogging, dynamic stretching, and movement preparation drills.
All exercise sessions were conducted on a standard track and field facility and lasted 40 minutes in total, consisting of a 10-minute standardized warm-up, 24 minutes of exercise, and a 5-minute recovery period. The exercise component was individually prescribed based on each participant's MAS, determined from the Yo-Yo Intermittent Recovery Test Level 1. All running distances were calculated individually using time × speed formulas based on each participant's MAS, ensuring workload equivalence across conditions.
High-Intensity Interval Exercise (HIIE): Participants ran at 105-110% of their MAS for 15-second intervals, covering a pre-calculated distance during each bout. After each 15-second sprint, they rested passively for 15 seconds and returned to their starting point. This was repeated continuously for 5 minutes, constituting one set. A total of four 5-minute sets were completed, interspersed with 2.5-minute passive rest periods, yielding a total exercise time of 30 minutes.
Moderate-Intensity Continuous Exercise (MICE): Participants ran continuously for 30 minutes at 70% of their MAS without rest.
Low-Intensity Continuous Exercise (LICE): Participants ran continuously for 30 minutes at 50% of their MAS without rest.
- Conditions
- Irisin, Lactate, Exercise Intensity
- Being tested
- Low-Intensity Continuous Exercise, Moderate Intensity Interval Exercise, High-Intensity Interval Exercise
- Keywords
- Peak time, Exercise Intensity, Irisin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Continuous ExerciseBehavioural
Also called LICE
Participants ran continuously for 30 minutes at 50% of their MAS without rest.
Moderate Intensity Interval ExerciseBehavioural
Also called MICE
Participants ran continuously for 30 minutes at 70% of their MAS without rest.
High-Intensity Interval ExerciseBehavioural
Also called HIIE
Participants ran at 105-110% of their MAS for 15-second intervals, covering a pre-calculated distance during each bout. After each 15-second sprint, they rested passively for 15 seconds and returned to their starting point. This was repeated continuously for 5 minutes, constituting one set. A total of four 5-minute sets were completed, interspersed with 2,5-minute passive rest periods, yielding a total exercise time of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Low-Intensity Continuous Exercise Group (n=4) | Experimental | Not described Receives: Behavioral: Low-Intensity Continuous Exercise |
| Modarate-Intensity Interval Exercise Group (n=4) | Experimental | Not described Receives: Behavioral: Moderate Intensity Interval Exercise |
| High-Intensity Interval Exercise Group (n=4) | Experimental | Not described Receives: Behavioral: High-Intensity Interval Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate
Lactate levels were measured in millimoles per liter (mmol/L) from capillary/venous blood samples taken before and after exercise using a lactate analyzer.
Measured: • Baseline, Immediately After Exercise (Day 1), 5 minute After Exercise (Day 1), 15 minutes After Exercise (Day 1), 30 minutes After Exercise (Day 1), 45 minutes After Exercise (Day 1), and 60 minutes After Exercise (Day 1).
Irisin
Irisin levels were measured using a Sunred brand ELISA kit from blood samples taken baseline and after exercise, and the results were reported in ng/mL units.
Measured: • Baseline, Immediately After Exercise (Day 1), 5 minute After Exercise (Day 1), 15 minutes After Exercise (Day 1), 30 minutes After Exercise (Day 1), 45 minutes After Exercise (Day 1), and 60 minutes After Exercise (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start29 Jul 2025
- Primary completion31 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IrisinStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, serkan pancar, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191015
- Sponsor's protocol ID
- 30.06/10.02
- Other IDs
- Ethics Committee
- Acronym
- TIDIER
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Dynamics of Irisin: Influence of Exercise Intensity on Peak Release
- ClinicalTrials.gov ID
- NCT07191015
- Acronym / sponsor ID
- TIDIER / 30.06/10.02
- Conditions
- Irisin, Lactate, Exercise Intensity
- Keywords
- Peak time, Exercise Intensity, Irisin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 24 Sep 2025 (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.
Purpose The purpose of this study was to determine the peak point of irisin following exercises of different intensities.
Method This randomized crossover controlled trial aimed to examine the acute effects of three experimental conditions-high-intensity interval training, long-interval continuous training, and low-intensity continuous training-on serum irisin and blood lactate levels in healthy young adults aged 18-25 years.
All participants completed the three conditions in a randomized and counterbalanced manner. To ensure balanced exposure, they were assigned to one of three groups (n = 4 per group), each following a distinct condition order based on a Latin square design. This approach guaranteed that each session occurred equally across time points (sessions 1-3) and that the order minimized sequence effects by rotating the position of each condition relative to the others.
To control for potential carryover-particularly from elevated endocrine responses following intense exercise (increases in irisin had been reported)-no two high-intensity sessions were scheduled consecutively. Where possible, higher- and lower-intensity protocols were alternated. Furthermore, a seven-day interval separated each session to reduce residual physiological or cognitive effects.
The trial protocol was developed in line with CONSORT and SPIRIT guidelines, including relevant extensions for within-subject designs and non-pharmacological interventions. Participants were blinded to the study hypothesis.
All exercise sessions were conducted in the morning (09:00-11:00) on a track and field pitch under the supervision of a certified strength and conditioning coach to ensure consistency and adherence to protocol. Participants were instructed to avoid strenuous activity for 48 hours prior, abstain from alcohol and caffeine for 24 hours, and obtain at least 7-8 hours of sleep before each session. Dietary habits and general lifestyle were kept unchanged throughout the study.
During the first visit, participants' body weight and body fat percentage were assessed using bioelectrical impedance analysis. Resting heart rate was then recorded, followed by administration of the Yo-Yo Intermittent Recovery Test Level 1 to determine maximal aerobic speed (MAS), aerobic capacity, and peak heart rate.
In the following four visits, each participant completed all experimental conditions. Each exercise session began with a standardized 10-minute warm-up, including light jogging, dynamic stretching, and movement preparation drills.
All exercise sessions were conducted on a standard track and field facility and lasted 40 minutes in total, consisting of a 10-minute standardized warm-up, 24 minutes of exercise, and a 5-minute recovery period. The exercise component was individually prescribed based on each participant's MAS, determined from the Yo-Yo Intermittent Recovery Test Level 1. All running distances were calculated individually using time × speed formulas based on each participant's MAS, ensuring workload equivalence across conditions.
High-Intensity Interval Exercise (HIIE): Participants ran at 105-110% of their MAS for 15-second intervals, covering a pre-calculated distance during each bout. After each 15-second sprint, they rested passively for 15 seconds and returned to their starting point. This was repeated continuously for 5 minutes, constituting one set. A total of four 5-minute sets were completed, interspersed with 2.5-minute passive rest periods, yielding a total exercise time of 30 minutes.
Moderate-Intensity Continuous Exercise (MICE): Participants ran continuously for 30 minutes at 70% of their MAS without rest.
Low-Intensity Continuous Exercise (LICE): Participants ran continuously for 30 minutes at 50% of their MAS without rest.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Continuous Exercise Group (n=4) | Experimental | Behavioral: Low-Intensity Continuous Exercise |
| Modarate-Intensity Interval Exercise Group (n=4) | Experimental | Behavioral: Moderate Intensity Interval Exercise |
| High-Intensity Interval Exercise Group (n=4) | Experimental | Behavioral: High-Intensity Interval Exercise |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 25 years
- No known medical condition that prevents participation in exercise
- Not currently using any pharmacological agents
Key exclusion criteria (5 listed)
- Experiencing any discomfort before, during, or after exercise
- Current or past diagnosis of pharmacological or doping substance use
- Engaging in regular exercise (more than 3 times per week) within the last 2 weeks
- History of alcohol or substance addiction
- Any other condition or factor that may prevent full participation in the study protocol
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 |
|---|---|---|
| Low-Intensity Continuous ExerciseAlso: LICEParticipants ran continuously for 30 minutes at 50% of their MAS without rest. | Behavioural | Low-Intensity Continuous Exercise Group (n=4) |
| Moderate Intensity Interval ExerciseAlso: MICEParticipants ran continuously for 30 minutes at 70% of their MAS without rest. | Behavioural | Modarate-Intensity Interval Exercise Group (n=4) |
| High-Intensity Interval ExerciseAlso: HIIEParticipants ran at 105-110% of their MAS for 15-second intervals, covering a pre-calculated distance during each bout. After each 15-second sprint, they rested passively for 15 seconds and returned to their starting point. This was repeated continuously for 5 minutes, constituting one set. A total of four 5-minute sets were completed, interspersed with 2,5-minute passive rest periods, yielding a total exercise time of 30 minutes. | Behavioural | High-Intensity Interval Exercise Group (n=4) |
Primary outcome
Lactate
Time frame: • Baseline, Immediately After Exercise (Day 1), 5 minute After Exercise (Day 1), 15 minutes After Exercise (Day 1), 30 minutes After Exercise (Day 1), 45 minutes After Exercise (Day 1), and 60 minutes After Exercise (Day 1).
Lactate levels were measured in millimoles per liter (mmol/L) from capillary/venous blood samples taken before and after exercise using a lactate analyzer.
Irisin
Time frame: • Baseline, Immediately After Exercise (Day 1), 5 minute After Exercise (Day 1), 15 minutes After Exercise (Day 1), 30 minutes After Exercise (Day 1), 45 minutes After Exercise (Day 1), and 60 minutes After Exercise (Day 1).
Irisin levels were measured using a Sunred brand ELISA kit from blood samples taken baseline and after exercise, and the results were reported in ng/mL units.
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 24 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Continuous Exercise, Moderate Intensity Interval Exercise and High-Intensity Interval Exercise in people with Irisin and Lactate, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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 24 Sep 2025. 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 Turkey (Türkiye). 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?
Lactate (time frame: • Baseline, Immediately After Exercise (Day 1), 5 minute After Exercise (Day 1), 15 minutes After Exercise (Day 1), 30 minutes After Exercise (Day 1), 45 minutes After Exercise (Day 1), and 60 minutes After Exercise (Day 1).). The study lists 2 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 24 Sep 2025.