Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03822663
Other study ID # ULS00007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 15, 2017
Est. completion date December 20, 2023

Study information

Verified date April 2024
Source Poznan University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to verify the effect of acute caffeine (CAF) and placebo (PLA) supplementation on physical capacity and discipline-specific exercise performance in athletes, in a randomised, double-blind, placebo-controlled crossover trial.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 20, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Caffeine supplementation
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.
Placebo treatment
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.

Locations

Country Name City State
Poland Department of Sports Dietetics, Poznan University of Physical Education Poznan Wielkopolska

Sponsors (2)

Lead Sponsor Collaborator
Poznan University of Physical Education Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in white blood cells and hematological indices (red blood cells, RBC) count in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (hemoglobin concentration, HGB) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (hematocrit, HCT) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (mean corpuscular volume, MCV; mean platelet volume, MPV) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (mean corpuscular hemoglobin mass, MCH) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (mean corpuscular hemoglobin concentration, MCHC) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (platelet count, PLT) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (platelet hematocrit, PCT) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other 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 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in hematological indices (red blood cells distribution width - standard deviation, RDW-S) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in nutritional status indices (concentration of urea and magnesium) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in nutritional status indices (concentration of glucose, calcium and phosphorans) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other Changes in muscle damage markers (concentration of creatine) in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Other 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 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 Baseline and during 1 day of acute CAF and PLA supplementation
Primary Changes in discipline-specific exercise capacity after caffeine supplementation and placebo treatment Assessment of the discipline-specific exercise capacity tests carried out at baseline, and after CAF and PLA supplementation Baseline and during 1 day of acute CAF and PLA supplementation
Primary Changes in caffeine and paraxanthine concencentrations in serum and saliva before and after caffeine supplementation and placebo treatment 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. Baseline and during 1 day of acute CAF and PLA supplementation
Primary Changes in reaction and motor time (Vienna Test System) after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Primary Changes in postural stability indices (COP velocity, Vcop) (posturographic platform AccuGaitTM) (after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Primary Changes in postural stability indices (area 95 percentile, Area95) (posturographic platform AccuGaitTM) after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Changes in sports training / competition activities after discipline-specific exercise tests Assessment of the sports training / competition activities after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Changes in rate of perceived exertion after discipline-specific exercise tests 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 Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Changes in heart rate during discipline-specific exercise tests Assessment of the Heart Rate during and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Analysis of psychological state before and after caffeine supplementation and placebo 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 Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Analysis of macronutrients in diets before and after caffeine supplementation and placebo treatment Assessment of the macronutrients in diets (g) was carried out before the execution of exercise protocols on each research visit Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Analysis of body composition (fat-free mass, fat mass) Assessment of body composition (fat-free mass, fat mass) (kg) was carried out before the execution of exercise protocols on each research visit Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Analysis of body composition (total body water) Assessment of body composition (total body water) (%) was carried out before the execution of exercise protocols on each research visit Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Changes in lactate and pyruvate concentrations in capillary blood before and after caffeine supplementation and placebo treatment 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 Baseline and during 1 day of acute CAF and PLA supplementation
Secondary Analysis of gene polymorphisms Assessment of the chosen gene polymorphisms in saliva carried out at baseline Baseline
See also
  Status Clinical Trial Phase
Completed NCT05597189 - Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain N/A
Recruiting NCT05444959 - The Impact of Exercise / Stress Stimuli on HMB Supplementation Efficacy Phase 2/Phase 3
Recruiting NCT03702205 - Betaine Effect in Speed-strength Athletes Phase 2/Phase 3
Completed NCT03165357 - Sodium Bicarbonate Supplementation in Athletes Phase 3
Completed NCT03406065 - Sodium Bicarbonate Supplementation in Combat Sports Athletes Phase 2/Phase 3
Recruiting NCT04549610 - HMB and Exercise-induced Muscle Damage Phase 2/Phase 3
Completed NCT06390670 - The Effect of Colostrum Bovinum Supplementation in Endurance Athletes Phase 2/Phase 3
Recruiting NCT05516212 - Caffeine Kinetics and CrossFit®-Specific Performance Phase 2/Phase 3
Completed NCT01235325 - The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients Phase 4
Completed NCT03028649 - The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes Phase 3
Completed NCT04427319 - The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists N/A
Completed NCT05750342 - Clinical Trial to Analyze the Efficacy of a Supplement Extracted From Persimmon on Overweight / Obesity. N/A
Active, not recruiting NCT03810404 - Acute Sodium Bicarbonate Supplementation in Athletes Phase 3
Completed NCT01275885 - Vitamin D Intervention in Infants - Pilot Phase 4
Completed NCT05525871 - Effects of Nitrates and Citrulline Malate on Performance in Professional Professional Soccer N/A
Recruiting NCT05878106 - Creatine Supplementation and Resistance Training in Patients With Breast Cancer N/A
Not yet recruiting NCT06327646 - Maternal Adherence to MMS in Nepal N/A