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Completed

NCT Number: NCT07103889

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

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.

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Key information

Conditions

Obese Adolescents Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

High Institute of Sports and Physical Education of Kef

Boulifa, Kef Governorate, 7100, Tunisia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Spartacus Test

Behavioral

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).

Primary outcomes

  1. Concentration of Blood Glucose (mg/dL)

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

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

  2. iron

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

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

  3. Concentration of Total Cholesterol (mg/dL)

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

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

  4. Concentration of HDL Cholesterol (mg/dL)

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

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

  5. Concentration of Triglycerides (mg/dL)

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

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

  6. Calculated LDL Cholesterol (mg/dL)

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

    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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  13. Concentration of Creatinine (mg/dL)

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

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

  14. Concentration of Urea (mg/dL)

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

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

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

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

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

  16. Glomerular Filtration Rate

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

    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).

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

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

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

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

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

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

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

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

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

  20. Hematocrit (Hct) (%)

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

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

  21. Platelet Count (10³/µL)

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

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

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

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

    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.

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

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

    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.

  24. Mean Corpuscular Volume (MCV) (fL)

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

    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

  25. Plasma volume variations

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

    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.

  26. Serum Sodium Concentration (mmol/L)

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

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

  27. Serum Potassium Concentration (mmol/L)

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

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

  28. Serum Chloride Concentration (mmol/L)

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

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

  29. Serum Calcium Concentration (mmol/L)

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

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

  30. Serum Phosphorus Concentration (mmol/L)

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

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

  31. Serum Magnesium Concentration (mg/dL)

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

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

  32. Serum Iron Concentration (µg/dL)

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

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

Sponsors and collaborators

Lead sponsor

High Institute of Sports and Physical Education of Kef

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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