The Influence of Caffeine Supplementation on Specific Performance and Training Activities

• ClinicalTrials.gov Identifier: NCT03822663
• Recruitment Status: Suspended
• First Posted: January 30, 2019
• Last Update Posted: April 10, 2020
• Sponsor: Poznan University of Life Sciences
• Collaborator: Poznan University of Physical Education
• Information provided by (Responsible Party): Krzysztof Durkalec-Michalski, PhD, Poznan University of Life Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Supplementation; Sports	Dietary Supplement: Caffeine supplementation; Dietary Supplement: Placebo treatment	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Influence of Caffeine Supplementation on Discipline-Specific Performance and Training Activities in Combat Sports and Speed-Strength Disciplines
• Actual Study Start Date: May 15, 2017
• Estimated Primary Completion Date: February 1, 2021
• Estimated Study Completion Date: March 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Caffeine supplementation; Group taking oral CAF (Caffeine) supplementation in a different-dose crossover regimen.	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 45 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 Comparator: Placebo treatment; Group taking oral supplementation with placebo.	Dietary Supplement: 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 45 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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Assessment of the discipline-specific exercise capacity tests carried out at baseline, and after CAF and PLA supplementation

Secondary Outcome Measures :

1. Changes in sports training / competition activities after discipline-specific exercise tests [ Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation ]
   Assessment of the sports training / competition activities after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation
2. Changes in rate of perceived exertion after discipline-specific exercise tests [ Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation ]
   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
3. Changes in heart rate during discipline-specific exercise tests [ Time Frame: Baseline and during 1 day of acute CAF and PLA supplementation ]
   Assessment of the Heart Rate during and after discipline-specific exercise tests carried out at baseline, and after CAF and PLA supplementation

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Poland

Poznan University of Life Sciences, ul.Wojska Polskiego 31

Poznań, Wielkopolska, Poland, 60-624

Sponsors and Collaborators

Poznan University of Life Sciences

Poznan University of Physical Education

Investigators

• Principal Investigator: Krzysztof Durkalec-Michalski, PhD; Poznan University of Life Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Durkalec-Michalski K, Nowaczyk PM, Główka 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.

• Responsible Party: Krzysztof Durkalec-Michalski, PhD, Principal Investigator, Poznan University of Life Sciences
• ClinicalTrials.gov Identifier: NCT03822663
• Other Study ID Numbers: ULS00007
• First Posted: January 30, 2019
• Last Update Posted: April 10, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Shared data will be exclusively related to the level of recorded indicators, without personal data. The data obtained will be attached to scientific publications, depending on the requirements of the journal.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Krzysztof Durkalec-Michalski, PhD, Poznan University of Life Sciences:

Sports nutrition; Caffeine; Physical capacity; Exercise performance

Additional relevant MeSH terms:

Caffeine; Central Nervous System Stimulants; Physiological Effects of Drugs; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents