High-Intensity Interval TrainingNCT06973980
HIIT in Sedentary Obese Adults: Effects on Metabolic Risk, Body Composition, and FABP4
A study testing Exercise in people with High-Intensity Interval Training, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
It is aimed to investigate the responses of Fatty Acid Binding Protein 4 (FABP4), which has been discovered as a novel biomarker of obesity and metabolic diseases, to regular exercise training. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- High-Intensity Interval Training
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCyprus
- Study dates
- 21 Apr 2025to 30 Oct 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 20 and 35 years,
- BMI between 30 and 35 kg/m²,
- Waist circumference of 90-100 cm for women, 105-110 cm for men,
- Sedentary lifestyle (<600 MET-min/week),
- Referred by a physician (with a statement confirming no contraindication to exercise)."
Who cannot join
- BMI > 35,
- Pregnancy,
- Cardiovascular Diseases: Individuals with serious cardiovascular issues, such as uncontrolled hypertension, heart failure, coronary artery disease, or a heart attack within the last 6 months, which could pose a risk during exercise.
- Respiratory Diseases: Individuals with chronic respiratory conditions, such as uncontrolled or severe asthma or COPD, who cannot tolerate exercise due to their condition.
- Neurological Disorders: Individuals with neurological issues that limit exercise capacity, such as Parkinson's disease, stroke, or multiple sclerosis.
- Musculoskeletal Issues: Individuals with chronic musculoskeletal problems, particularly knee or hip osteoarthritis, that may increase the risk of pain or injury during exercise.
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- Metabolic or Endocrine Disorders: Individuals with uncontrolled metabolic issues, such as diabetes or thyroid disorders, that could cause blood sugar or hormonal fluctuations during exercise.
- Acute Infections or Illness: Individuals with acute infections, fever, or recently undergone surgical procedures.
- Any health condition that may prevent participation in exercise."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-Intensity Interval Training on Cardiometabolic Risk Factors, Body Composition, and Plasma FABP4 Levels in Sedentary Obese Adults.
It is aimed to investigate the responses of Fatty Acid Binding Protein 4 (FABP4), which has been discovered as a novel biomarker of obesity and metabolic diseases, to regular exercise training.
The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.
Read the detailed description
Fatty acid binding proteins are intracellular proteins involved in the transport of fatty acids and are particularly associated with lipolytic activity. These proteins constitute a group of molecules that regulate intracellular lipid responses and are linked to metabolic and inflammatory pathways.
Studies have shown that FABP4 is associated with hypertension, insulin resistance, obesity, and stroke.
Inhibition of FABP4 synthesis has emerged as a promising strategy for the treatment of obesity-related conditions, particularly insulin resistance and diabetes, and it is emphasized that exercise models to suppress FABP4 should be further investigated.
The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.
Hypotheses:
H01: HIIT has no effect on cardiometabolic risk factors in sedentary obese adults.
H02: HIIT has no effect on body composition in sedentary obese adults. H03: HIIT has no effect on plasma FABP4 levels in sedentary obese adults.
- Conditions
- High-Intensity Interval Training
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The exercises will be applied only to the intervention group for 12 weeks and will be progressively intensified every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | High-Intensity Interval Training (HIIT)
1-minute interval, 1-minute active recovery 5-minute warm-up, 3-minute cool-down at 60% of peak heart rate.
Weeks 1-2:
Intensity at 85% of peak heart rate during work, active recovery at 60% of peak heart rate, 4 sets of 1-minute work.
Weeks 2-7:
Intensity at 90% of peak heart rate during work, active recovery at 60% of peak heart rate, 6 sets of 1-minute work.
Weeks 8-12:
Intensity at 90% of peak heart rate during work, active recovery at 60% of peak heart rate, 8 sets of 1-minute work. Receives: Other: Exercise |
| Control Group | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid-bling protein 4
The Human FABP4 (Fatty Acid Binding Protein 4, Adipocyte) ELISA Kit/96T/Feiyuebio will be used to evaluate fatty acid-binding proteins in the biological samples collected from the participants.
Measured: Baseline, week 6 and week 12
Complete Blood Count
used to evaluate overall health and detect a wide range of disorders, including anemia, infection, and many other diseases.
Measured: Baseline, week 6 and week 12
Hemoglobin A1c (HbA1c)
used to measure the average blood glucose levels over the past 2 to 3 months; commonly used in the diagnosis and management of diabetes.
Measured: Baseline, week 6 and week 12
Hematocrit (HCT)
sed to measure the proportion of red blood cells in the blood; helps evaluate conditions such as anemia, dehydration, and other blood disorders.
Measured: Baseline, week 6 and week 12
Low-Density Lipoprotein
used to measure the level of "bad" cholesterol in the blood; high levels are associated with an increased risk of cardiovascular disease.
Measured: Baseline, week 6 and week 12
High-Density Lipoprotein
Used to quantify the concentration of high-density lipoprotein (HDL) cholesterol in the bloodstream; elevated levels of HDL are inversely correlated with the risk of cardiovascular diseases, suggesting a protective effect on heart health.
Measured: Baseline, week 6 and week 12
Triglycerides
used to measure the concentration of triglycerides (a type of fat) in the blood; elevated levels are associated with an increased risk of cardiovascular disease, metabolic syndrome, and other health conditions.
Measured: Baseline, week 6 and week 12
Fasting Blood Glucose (FBG)
used to measure the concentration of glucose in the blood after an overnight fast; elevated levels may indicate impaired glucose metabolism or diabetes mellitus.
Measured: Baseline, week 6 and week 12
Total Cholesterol
used to measure the overall concentration of cholesterol in the blood, including low-density lipoprotein (LDL), high-density lipoprotein (HDL), and very-low-density lipoprotein (VLDL); elevated levels are associated with an increased risk of cardiovascular diseases.
Measured: Baseline, week 6 and week 12
Secondary outcomes (6)
Physical Activity Level Assessment
The International Physical Activity Questionnaire Short Form will be used. A validity and reliability study has been conducted in Turkish, with test-retest reliability determined to be r=0.69. This form is self-administered and consists of seven questions assessing physical activity levels over the 'last seven days.' It provides information on time spent sitting, walking, engaging in moderate-intensity activities, and vigorous-intensity activities. The score is calculated by multiplying the minutes, days, and MET values. For calculations, 8 MET is used for vigorous physical activity, 4 MET for moderate-intensity activity, and 3.3 MET for walking. Since the scale is openly accessible, no usage permission is required.
Measured: Baseline, week 6 and week 12
Physical activity level
- High Activity Level: Individuals who engage in vigorous-intensity physical activity (≥8 METs) for at least 3 days per week, accumulating a total of at least 1500 MET-minutes/week, or individuals who engage in any combination of physical activities across 7 days, accumulating at least 3000 MET-minutes/week.
- Moderate Activity Level: Individuals who perform vigorous-intensity activity for more than 20 minutes on at least 3 days per week, or moderate-intensity activity for more than 30 minutes on at least 5 days per week, or those who accumulate a total of at least 600 MET-minutes/week through any combination of physical activities.
- Low Activity (Sedentary) Level: Individuals whose total physical activity is less than 600 MET-minutes/week are considered sedentary. This indicates minimal physical activity, primarily consisting of sitting, light movement, and a generally inactive lifestyle.
Measured: Baseline, week 6 and week 12
Assessment of Aerobic Capacity and Exercise Intensity - used to measure an individual's maximal oxygen uptake (VO2max) and determine the intensity of exercise
The Bruce Treadmill Test protocol will be used to determine aerobic capacity and exercise intensity. Developed by Robert A. Bruce, the Bruce Treadmill Test protocol is widely used today for non-invasive estimation of VO2max. The incline and speed are regularly increased to reach the maximum level that an individual can achieve. The test consists of 9 stages. Prior to the test, participants will receive the necessary information, and their resting blood pressure, heart rate, and oxygen saturation will be measured. At the end of each stage, an ECG measurement will be taken in addition to these measurements, and at the end of the test, all measurements will be repeated. The peak heart rate obtained at the end of the test will be considered the maximal heart rate. Additionally, the peak heart rate obtained will be used to determine the intensity of the exercise protocols.
Measured: Baseline, week 6 and week 12
Height
Height will be measured in meters (m) using stadiometer
Measured: Baseline
Body Weight
Body weight (kg) will be assessed using a Body Fat Analyzer.
Measured: Baseline, week 6 and week 12
body mass indeks (kg/m²)
body mass indeks (kg/m²) will be calculated. Height measured at baseline will be used for BMI calculation at all time points
Measured: Baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start21 Apr 2025
- Primary completion15 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Intensity Interval TrainingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YAŞAM DİREL, MSc, Principal investigator, Eastern Meditterean university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973980
- Sponsor's protocol ID
- YDIREL
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-Intensity Interval Training on Cardiometabolic Risk Factors, Body Composition, and Plasma FABP4 Levels in Sedentary Obese Adults.
- ClinicalTrials.gov ID
- NCT06973980
- Acronym / sponsor ID
- YDIREL
- Conditions
- High-Intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 15 May 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.
It is aimed to investigate the responses of Fatty Acid Binding Protein 4 (FABP4), which has been discovered as a novel biomarker of obesity and metabolic diseases, to regular exercise training.
The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.
Detailed description
Fatty acid binding proteins are intracellular proteins involved in the transport of fatty acids and are particularly associated with lipolytic activity. These proteins constitute a group of molecules that regulate intracellular lipid responses and are linked to metabolic and inflammatory pathways.
Studies have shown that FABP4 is associated with hypertension, insulin resistance, obesity, and stroke.
Inhibition of FABP4 synthesis has emerged as a promising strategy for the treatment of obesity-related conditions, particularly insulin resistance and diabetes, and it is emphasized that exercise models to suppress FABP4 should be further investigated.
The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.
Hypotheses:
H01: HIIT has no effect on cardiometabolic risk factors in sedentary obese adults.
H02: HIIT has no effect on body composition in sedentary obese adults. H03: HIIT has no effect on plasma FABP4 levels in sedentary obese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: ExerciseHigh-Intensity Interval Training (HIIT) 1-minute interval, 1-minute active recovery 5-minute warm-up, 3-minute cool-down at 60% of peak heart rate. Weeks 1-2: Intensity at 85% of peak heart rate during work, active recovery at 60% of peak heart rate, 4 sets of 1-minute work. Weeks 2-7: Intensity at 90% of peak heart rate during work, active recovery at 60% of peak heart rate, 6 sets of 1-minute work. Weeks 8-12: Intensity at 90% of peak heart rate during work, active recovery at 60% of peak heart rate, 8 sets of 1-minute work. |
| Control Group | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 20 and 35 years,
- BMI between 30 and 35 kg/m²,
- Waist circumference of 90-100 cm for women, 105-110 cm for men,
- Sedentary lifestyle (<600 MET-min/week),
- Referred by a physician (with a statement confirming no contraindication to exercise)."
Key exclusion criteria (9 listed)
- BMI > 35,
- Pregnancy,
- Cardiovascular Diseases: Individuals with serious cardiovascular issues, such as uncontrolled hypertension, heart failure, coronary artery disease, or a heart attack within the last 6 months, which could pose a risk during exercise.
- Respiratory Diseases: Individuals with chronic respiratory conditions, such as uncontrolled or severe asthma or COPD, who cannot tolerate exercise due to their condition.
- Neurological Disorders: Individuals with neurological issues that limit exercise capacity, such as Parkinson's disease, stroke, or multiple sclerosis.
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 |
|---|---|---|
| ExerciseThe exercises will be applied only to the intervention group for 12 weeks and will be progressively intensified every 4 weeks. | Other | Exercise Group |
Primary outcome
Fatty acid-bling protein 4
Time frame: Baseline, week 6 and week 12
The Human FABP4 (Fatty Acid Binding Protein 4, Adipocyte) ELISA Kit/96T/Feiyuebio will be used to evaluate fatty acid-binding proteins in the biological samples collected from the participants.
Complete Blood Count
Time frame: Baseline, week 6 and week 12
used to evaluate overall health and detect a wide range of disorders, including anemia, infection, and many other diseases.
Hemoglobin A1c (HbA1c)
Time frame: Baseline, week 6 and week 12
used to measure the average blood glucose levels over the past 2 to 3 months; commonly used in the diagnosis and management of diabetes.
Hematocrit (HCT)
Time frame: Baseline, week 6 and week 12
sed to measure the proportion of red blood cells in the blood; helps evaluate conditions such as anemia, dehydration, and other blood disorders.
Low-Density Lipoprotein
Time frame: Baseline, week 6 and week 12
used to measure the level of "bad" cholesterol in the blood; high levels are associated with an increased risk of cardiovascular disease.
High-Density Lipoprotein
Time frame: Baseline, week 6 and week 12
Used to quantify the concentration of high-density lipoprotein (HDL) cholesterol in the bloodstream; elevated levels of HDL are inversely correlated with the risk of cardiovascular diseases, suggesting a protective effect on heart health.
Triglycerides
Time frame: Baseline, week 6 and week 12
used to measure the concentration of triglycerides (a type of fat) in the blood; elevated levels are associated with an increased risk of cardiovascular disease, metabolic syndrome, and other health conditions.
Fasting Blood Glucose (FBG)
Time frame: Baseline, week 6 and week 12
used to measure the concentration of glucose in the blood after an overnight fast; elevated levels may indicate impaired glucose metabolism or diabetes mellitus.
Total Cholesterol
Time frame: Baseline, week 6 and week 12
used to measure the overall concentration of cholesterol in the blood, including low-density lipoprotein (LDL), high-density lipoprotein (HDL), and very-low-density lipoprotein (VLDL); elevated levels are associated with an increased risk of cardiovascular diseases.
6 secondary outcomes
Physical Activity Level Assessment
Time frame: Baseline, week 6 and week 12
Physical activity level
Time frame: Baseline, week 6 and week 12
Assessment of Aerobic Capacity and Exercise Intensity - used to measure an individual's maximal oxygen uptake (VO2max) and determine the intensity of exercise
Time frame: Baseline, week 6 and week 12
Height
Time frame: Baseline
Body Weight
Time frame: Baseline, week 6 and week 12
body mass indeks (kg/m²)
Time frame: Baseline, week 6 and week 12
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 9 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.
YAŞAM DİREL, MSc principal investigator
Eastern Meditterean university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with High-Intensity Interval Training, run by Eastern Mediterranean University at 1 site in Cyprus.
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 5 inclusion and 9 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 9 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 Cyprus. 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?
Fatty acid-bling protein 4 (time frame: Baseline, week 6 and week 12). The study lists 9 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 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.