The Influence of Caffeine Supplementation on Specific Performance and Training Activities

NCT03822663 | Completed Phase 3

• 1 other identifier: ULS00007
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Supplementation; Sports

Keywords

Sports nutrition; Caffeine; Physical capacity; Exercise performance

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Changes in sports training / competition activities after discipline-specific exercise tests

  Baseline and during 1 day of acute CAF and PLA supplementation

• Changes in rate of perceived exertion after discipline-specific exercise tests

  Baseline and during 1 day of acute CAF and PLA supplementation

• Changes in heart rate during discipline-specific exercise tests

  Baseline and during 1 day of acute CAF and PLA supplementation

• Analysis of psychological state before and after caffeine supplementation and placebo

  Baseline and during 1 day of acute CAF and PLA supplementation

• Analysis of macronutrients in diets before and after caffeine supplementation and placebo treatment

  Baseline and during 1 day of acute CAF and PLA supplementation

Other Outcomes (14)

• Changes in white blood cells and hematological indices (red blood cells, RBC) count in capillary blood before and after caffeine supplementation and placebo treatment

  Baseline and during 1 day of acute CAF and PLA supplementation

• Changes in hematological indices (hemoglobin concentration, HGB) in capillary blood before and after caffeine supplementation and placebo treatment

  Baseline and during 1 day of acute CAF and PLA supplementation

• Changes in hematological indices (hematocrit, HCT) in capillary blood before and after caffeine supplementation and placebo treatment

  Baseline and during 1 day of acute CAF and PLA supplementation

Study Arms (2)

Caffeine supplementation

EXPERIMENTAL

Group taking oral CAF (Caffeine) supplementation in a different-dose crossover regimen.

Dietary Supplement: Caffeine supplementation

Placebo treatment

PLACEBO COMPARATOR

Group taking oral supplementation with placebo.

Dietary Supplement: Placebo treatment

Interventions

Caffeine supplementation DIETARY_SUPPLEMENT

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.

Caffeine supplementation

Placebo treatment DIETARY_SUPPLEMENT

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.

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• current injury,
• any health-related contraindication,
• declared general feeling of being unwell,
• unwilling to follow the study protocol.

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• Poznan University of Life Sciences: collaborator

Study Sites (1)

Department of Sports Dietetics, Poznan University of Physical Education

Poznan, Wielkopolska, 61-871, Poland

Location

Related Publications (2)

• Glowka N, Malik J, Aniola J, Zawieja EE, Chmurzynska A, Durkalec-Michalski K. The effect of caffeine dose on caffeine and paraxanthine changes in serum and saliva and CYP1A2 enzyme activity in athletes: a randomized placebo-controlled crossover trial. Nutr Metab (Lond). 2024 Nov 11;21(1):90. doi: 10.1186/s12986-024-00863-3.

  PMID: 39529054 DERIVED

• Durkalec-Michalski K, Nowaczyk PM, Glowka N, Grygiel A. Dose-dependent effect of caffeine supplementation on judo-specific performance and training activity: a randomized placebo-controlled crossover trial. J Int Soc Sports Nutr. 2019 Sep 5;16(1):38. doi: 10.1186/s12970-019-0305-8.

  PMID: 31488190 DERIVED

Study Officials

• Krzysztof Durkalec-Michalski, PhD

  Department of Sports Dietetics, Poznan University of Physical Education, Poznan, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: May 15, 2017
• Primary Completion: March 1, 2023
• Study Completion: December 20, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

PL (1)