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Obese AdolescentsNCT07103889

Effect of Acute Exercise on Biochemical Parameters in Normal-Weight and Overweight/Obese Adolescent.

A study testing Spartacus Test in people with Obese Adolescents and Overweight, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this interventional clinical trial is to compare the acute physiological and biochemical responses to maximal physical exercise (Spartacus test). in two groups of adolescent girls: in normal-weight and overweight/obese adolescent. Read more about this study

Who is it for?
Ages 13 to 18 years, women only
Conditions the study is for
Obese Adolescents, Overweight
What is being tested?
Spartacus Test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteTunisia
Study dates
10 Aug 2025to 13 Aug 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 13 to 18 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Female,
  • Aged 14-18 years
  • BMI between the 5th and <85th percentile for age (normal-weight group), or BMI ≥ 85th percentile for age (overweight/obese group)
  • No chronic illness or contraindication to exercise
  • No regular medication use
  • Written informed consent from participant and parent/legal guardian

Who cannot join

  • Presence of chronic diseases (diabetes, thyroid disorders, etc.)
  • Musculoskeletal or cardiovascular contraindications to maximal exercise
  • Pregnancy
  • Recent infection or inflammation
  • Use of anti-inflammatory or hormonal medications

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • High Institute of Sports and Physical Education of Kef

    Boulifa, Kef Governorate, 7100

Other trials in Tunisia

About this study

Official title: Assessment of Biochemical, Metabolic, Inflammatory, and Hematological Parameters Following Acute Exercise in Normal-Weight and Overweight/Obese Adolescent Girls.

The goal of this interventional clinical trial is to compare the acute physiological and biochemical responses to maximal physical exercise (Spartacus test). in two groups of adolescent girls: in normal-weight and overweight/obese adolescent. The main question it aims to answer:

  • Does Spartacus test significantly alter glucose metabolism and lipid profile in normal-weight and overweight/obese adolescent?
  • How do inflammatory markers such as C-Reactive Protein [CRP], Erythrocyte Sedimentation Rate [ESR], respond immediately after and 30 minutes following maximal effort?
  • Are there significant changes in liver enzymes (Aspartate Aminotransferase [AST], Alanine Aminotransferase [ALT]), muscle damage indicators (creatine kinase [CK], Lactate Dehydrogenase [LDH]), and electrolyte balance post-exercise? Participants will undergo a baseline blood draw before performing the Spartacus test , a progressive maximal exercise test. Blood samples will then be collected immediately after the test and again 30 minutes post-exercise to evaluate changes in: Glucose metabolism (fasting glucose), Lipid profile (total cholesterol, High-Density Lipoprotein [HDL], Low-Density Lipoprotein [LDL], triglycerides), Liver and muscle enzymes (Aspartate Aminotransferase [AST], Alanine Aminotransferase [ALT], Creatine kinase [CK], Lactate Dehydrogenase [LDH]), Renal function markers (creatinine, urea), Inflammatory markers (C-Reactive Protein [CRP], Erythrocyte Sedimentation Rate [ESR]), Hematological profile (complete blood count: White Blood Cells [WBC], Red Blood Cells [RBC], Hemoglobin [Hb], Hematocrit [Hct], platelets), Electrolytes (sodium, potassium, chloride), Uric acid, calcium, phosphorus, magnesium, iron.
Read the detailed description

This is an interventional clinical trial designed to evaluate the acute physiological and biochemical responses to maximal physical exercise (Spartacus test) in normal-weight and overweight/obese adolescent. The study aims to investigate how a single session Spartacus test affects key metabolic, inflammatory, hepatic, muscular, renal, and hematological parameters.

Participants will be divided into two groups:

Group 1: Normal-weight adolescent girls Adolescent girls with a body mass index (BMI) between the 5th and <85th percentile for age.

Group 2: Overweight/obese adolescent girls Adolescent girls with a BMI ≥ 85th percentile for age. The protocol involves running on a simulated rectangular course (750 m²), with increasing speed every 3 minutes (starting at 7 km/h and increasing by 1 km/h each stage). Participants must reach a marked cone corresponding to the new speed within 15 seconds, followed by a 15-second rest period before the next stage begins. The test continues until voluntary exhaustion or inability to maintain the required pace.

Blood samples will be collected at three time points:

Baseline (Time 0): Before the start of the exercise. Immediately post-exercise (Time 1): Within 5 minutes after completion of the test.

30 minutes post-exercise (Time 2): To assess early recovery kinetics.

The following biomarkers will be measured at each time point:

Metabolic profile: Fasting glucose, lipid panel (total cholesterol, HDL, LDL, triglycerides), uric acid Liver function: AST, ALT, LDH, CK Renal function: Creatinine, urea Inflammatory markers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) Hematological profile: Complete blood count (CBC), including white blood cell differential, hemoglobin, hematocrit, red blood cell indices, and platelet count Electrolytes: Sodium (Na⁺), potassium (K⁺), chloride (Cl-) Minerals and trace elements: Calcium, phosphorus, magnesium, iron

Being tested
Spartacus Test
Keywords
Adolescent, Maximal Exercise, Blood Biomarkers, Liver Enzymes, Lipid Profile, Renal Function, obesity, overweight, Normal-weight
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spartacus TestBehavioural

    The Spartacus test was conducted on a 750 m (75 × 10 m) rectangular course marked with cones at regular intervals to indicate different speeds (from 7 to 18 km/h). Each participant began running at 7 km/h, with speed increasing by 1 km/h every three minutes.During the 3-minute intervals (for each speed stage), participants had 15 seconds to reach the corresponding marker, followed by 15 seconds of rest. Participants had to adjust their running pace to reach the target cone in synchrony with an audio signal. The test ended when a participant failed to reach the next cone within the given time. This test is validated for assessing maximal aerobic capacity (MAS) in obese adolescents. During the Spartacus test, maximal heart rate (HRmax) was recorded using a heart rate monitor (S810; Polar, Kempele, Finland).

Study groups in NCT07103889
Study groupRoleWhat they receive
Normal-weight adolescent girlsExperimentalBody mass index (BMI) between the 5th and <85th percentile for age.
Receives: Behavioral: Spartacus Test
Overweight/obese adolescentExperimentalBMI ≥ 85th percentile for age.
Receives: Behavioral: Spartacus Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of Blood Glucose (mg/dL)

    Blood glucose levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  2. iron

    Serum iron concentration will be measured using a colorimetric assay in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  3. Concentration of Total Cholesterol (mg/dL)

    Total cholesterol will be assessed using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  4. Concentration of HDL Cholesterol (mg/dL)

    HDL cholesterol will be analyzed using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  5. Concentration of Triglycerides (mg/dL)

    Triglyceride levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  6. Calculated LDL Cholesterol (mg/dL)

    LDL cholesterol will be estimated using the Friedewald formula based on total cholesterol, HDL cholesterol, and triglycerides measured via enzymatic colorimetric assays in a certified clinical laboratory.

    LDL-C (mg/dL)=Cholesterol total-HDL Cholesterol-( Triglycerides /5)

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  7. Concentration of C-Reactive Protein (CRP) (mg/L)

    CRP levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  8. Erythrocyte Sedimentation Rate (ESR) (mm/hr)

    ESR will be determined using standard laboratory methods in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  9. Concentration of Aspartate Aminotransferase (AST) (U/L)

    AST levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  10. Concentration of Alanine Aminotransferase (ALT) (U/L)

    ALT levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  11. Concentration of Lactate Dehydrogenase (LDH) (U/L)

    LDH levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  12. Concentration of Creatine Kinase (CK) (U/L)

    CK levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  13. Concentration of Creatinine (mg/dL)

    Creatinine levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  14. Concentration of Urea (mg/dL)

    Urea levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  15. Concentration of Serum Uric Acid (mg/dL)

    Serum concentrations of uric acid will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  16. Glomerular Filtration Rate

    The glomerular Filtration Rate (GFR) has been computed using the Cockcroft formula, as follows: GFR (mL/min) = [(140 - age) × weight ×0.85]/( Serum Creatinine× 72).

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  17. White Blood Cell Count (WBC) (10³/µL)

    WBC will be measured using standard hematology analyzers in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  18. Red Blood Cell Count (RBC) (10³/µL)

    RBC will be measured using standard hematology analyzers in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  19. Hemoglobin Concentration (Hb) (g/dL)

    Hb concentration will be measured using standard hematology analyzers in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  20. Hematocrit (Hct) (%)

    Hematocrit will be measured using standard hematology analyzers in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  21. Platelet Count (10³/µL)

    Platelet count will be measured using standard hematology analyzers in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  22. Mean Corpuscular Hemoglobin Content (MCH) (pg)

    Blood levels of mean corpuscular hemoglobin content will be measured from a 5 ml blood sample and analyzed using a multichannel automated hematology analyzer in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  23. Mean Hemoglobin Concentration (MCHC) (g/dL)

    Blood levels of mean hemoglobin concentration will be measured from a 5 ml blood sample and analyzed using a multichannel automated hematology analyzer in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  24. Mean Corpuscular Volume (MCV) (fL)

    Blood levels of mean corpuscular volume will be measured from a 5 ml blood sample and analyzed using a multichannel automated hematology analyzer in a certified clinical laboratory

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  25. Plasma volume variations

    Plasma volume variations (PVV) was calculated based on measured hematocrit (Ht) and hemoglobin (Hb) valuesaccording to the method developed by Costill and Fink (1974). %PVV=100 ×[(HbA/HbB) ×(100 - HtB) / (100 - HtA)] -

    1, where 0 is the value measured before exercise and 1 is the value measured after exercise.

    Measured: Plasma volume variations (PVV) was calculated Immediately after Spartacus, and 30 minutes post-Spartacus.

  26. Serum Sodium Concentration (mmol/L)

    Serum sodium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  27. Serum Potassium Concentration (mmol/L)

    Serum potassium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  28. Serum Chloride Concentration (mmol/L)

    Serum chloride levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  29. Serum Calcium Concentration (mmol/L)

    Serum calcium levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  30. Serum Phosphorus Concentration (mmol/L)

    Serum phosphorus levels will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  31. Serum Magnesium Concentration (mg/dL)

    Serum magnesium concentration will be determined using a spectrophotometric colorimetric method in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

  32. Serum Iron Concentration (µg/dL)

    Serum iron concentration will be measured using enzymatic colorimetric assays in a certified clinical laboratory.

    Measured: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start10 Aug 2025
  3. Primary completion13 Aug 2025
  4. Study completion13 Aug 2025

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07103889
Sponsor's protocol ID
ACUTE-EXER-OBESE-2025
Status last verified
Jul 2025
First submitted
18 Jul 2025
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Spartacus Test in people with Obese Adolescents and Overweight, 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 6 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 11 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 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?

Concentration of Blood Glucose (mg/dL) (time frame: At baseline, Immediately after Spartacus, and 30 minutes post-Spartacus.). The study lists 32 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 11 Sep 2025; AzTrials last refreshed its copy on 4 Nov 2026.

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