- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822663
The Influence of Caffeine Supplementation on Specific Performance and Training Activities
The Influence of Caffeine Supplementation on Discipline-Specific Performance and Training Activities in Combat Sports and Speed-Strength Disciplines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Caffeine (CAF) is often proposed as an ergogenic agent, especially during high-intensity efforts. CAF supplementation may reduce effort-induced multi-faceted symptoms of fatigue and can improve psychomotor functions (like agility or decision-making processes), which is required during the intermittent high-intensity efforts in combat sports and speed-strength disciplines. Moreover, it is suggested that CAF treatment is associated with increased glycolytic activity during simulated or real training/competition bouts, which results in performance and physical capacity improvement.
However, there are hardly any data on the individual CAF-induced and dose-dependent changes in physical capacity and discipline-specific performance in combat sports and speed-strength disciplines. Therefore, the study aims to examine the effect of acute, different-dose CAF ingestion on physical capacity and discipline-specific performance in combat sports and speed-strength athletes, in a randomized, double-blind, placebo-controlled crossover trial.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Wielkopolska
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Poznań, Wielkopolska, Poland, 61-871
- Department of Sports Dietetics, Poznan University of Physical Education
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- written consent to participate,
- a current medical clearance to practice sports,
- training experience: at least 2 years,
- minimum of 4 workout sessions (in the discipline covered by the study) a week.
Exclusion Criteria:
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Caffeine supplementation
Group taking oral CAF (Caffeine) supplementation in a different-dose crossover regimen.
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The experimental procedure for each athlete includes an acute CAF supplementation in a different-dose crossover regimen in order to assess whether the dose affects the actual physical capacity and discipline-specific exercise performance (doses: 3.0-, 6.0- and 9.0 mg/kg of body mass, respectively).
CAF (pure pharmaceutical caffeine) will be administered in the dissolved form.
On testing days, the supplements will be taken 70 min before physical and exercise capacity test session.
Between the CAF and PLA or a PLA and CAF treatments, a minimum 7-day washout period will be introduced.
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Placebo Comparator: Placebo treatment
Group taking oral supplementation with placebo.
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The experimental procedure for each athlete will include PLA supplementation.
Placebo will be administered in the dissolved form.
On testing days, the PLA will be taken 70 min before physical and exercise capacity test session.
Between the PLA and CAF or a CAF and PLA treatments, a minimum 7-day washout period will be introduced.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in discipline-specific exercise capacity after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the discipline-specific exercise capacity tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in caffeine and paraxanthine concencentrations in serum and saliva before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the caffeine and paraxanthine concencentrations (μg/mL), and paraxanthine/caffeine ratio in serum and saliva before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation.
Additionally CYP1A2 enzyme activity was assessed by the determination of the mean time-corrected PRX/CAF RATIO in saliva.
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in reaction and motor time (Vienna Test System) after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the reaction and motor time (Vienna Test System) (ms) before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in postural stability indices (COP velocity, Vcop) (posturographic platform AccuGaitTM) (after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the postural stability indices (COP velocity, Vcop) (posturographic platform AccuGaitTM) (cm/s) before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in postural stability indices (area 95 percentile, Area95) (posturographic platform AccuGaitTM) after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the postural stability indices (area 95 percentile, Area95) (posturographic platform AccuGaitTM) (cm2) before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in sports training / competition activities after discipline-specific exercise tests
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the sports training / competition activities after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in rate of perceived exertion after discipline-specific exercise tests
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the Borg Rating of Perceived Exertion (RPE) scale after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in heart rate during discipline-specific exercise tests
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the Heart Rate during and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Analysis of psychological state before and after caffeine supplementation and placebo
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of psychological state by chosen questionnaires was carried out before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Analysis of macronutrients in diets before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the macronutrients in diets (g) was carried out before the execution of exercise protocols on each research visit
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Baseline and during 1 day of acute CAF and PLA supplementation
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Analysis of body composition (fat-free mass, fat mass)
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of body composition (fat-free mass, fat mass) (kg) was carried out before the execution of exercise protocols on each research visit
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Baseline and during 1 day of acute CAF and PLA supplementation
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Analysis of body composition (total body water)
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of body composition (total body water) (%) was carried out before the execution of exercise protocols on each research visit
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in lactate and pyruvate concentrations in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the lactate and pyruvate concentration (mmol/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Analysis of gene polymorphisms
Time Frame: Baseline
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Assessment of the chosen gene polymorphisms in saliva carried out at baseline
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Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in white blood cells and hematological indices (red blood cells, RBC) count in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the leukocytes (neutrophils, monocytes, lymphocytes, neutrophils:lymphocytes ratio) and the hematological indices (red blood cells, RBC)(count/L) count in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (hemoglobin concentration, HGB) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (hemoglobin concentration, HGB) (mmol/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (hematocrit, HCT) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (hematocrit, HCT) (L/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (mean corpuscular volume, MCV; mean platelet volume, MPV) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (mean corpuscular volume, MCV; mean platelet volume, MPV) (fL) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (mean corpuscular hemoglobin mass, MCH) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (mean corpuscular hemoglobin mass, MCH) (fmol) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (mean corpuscular hemoglobin concentration, MCHC) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (mean corpuscular hemoglobin concentration, MCHC) (mmol/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (platelet count, PLT) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (platelet count, PLT) (count x 109/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (platelet hematocrit, PCT) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (platelet hematocrit, PCT) (cL/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (platelet distribution width, PDW; platelet large cell ratio, PLCR; red blood cells distribution width - coefficient of variation, RDW-C) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (platelet distribution width, PDW; platelet large cell ratio, PLCR; red blood cells distribution width - coefficient of variation, RDW-C) (%) in in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in hematological indices (red blood cells distribution width - standard deviation, RDW-S) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the hematological indices (red blood cells distribution width - standard deviation, RDW-S) (fL) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in nutritional status indices (concentration of urea and magnesium) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the nutritional status indices (concentration of urea and magnesium) (mmol/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in nutritional status indices (concentration of glucose, calcium and phosphorans) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the nutritional status indices (concentration of glucose, calcium and phosphorans) (mg/dL) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in muscle damage markers (concentration of creatine) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the muscle damage markers (concentration of creatine) (μmol/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Changes in muscle damage markers (activity of alanine aminotransferase, aspartate aminotransferase, creatine kinase, lactate dehydrogenase)) in capillary blood before and after caffeine supplementation and placebo treatment
Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation
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Assessment of the muscle damage markers (activity of alanine aminotransferase, aspartate aminotransferase, creatine kinase, lactate dehydrogenase) (U/L) in capillary blood before and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
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Baseline and during 1 day of acute CAF and PLA supplementation
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Krzysztof Durkalec-Michalski, PhD, Department of Sports Dietetics, Poznan University of Physical Education, Poznan, Poland
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULS00007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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