Caffeine Kinetics and CrossFit®-Specific Performance

NCT05516212 | Recruiting Phase 2

• 1 other identifier: ZDS2022_0003
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims at assessing the relation between caffeine (CAF) and paraxanthine (PAX) kinetics after acute ingestion of caffeine (3 mg/kg body mass) in the form or mono- or multi-ingredient preparations and CrossFit®-specific performance or selected indicators of psychophysiological state. Blood indicators of muscle damage/recovery, acid-base balance and electrolytes levels will be evaluated. The impact of genetic variations in the polymorphisms rs5751876 in ADORA2A gene and rs762551 in CYP1A2 on CAF/PAX kinetics will be considered.

Conditions

Supplementation; Sports Nutrition; Ergogenic Support; Discipline-specific Performance

Keywords

Pre-workout supplementation; caffeine; high-intensity interval training; high-intensity functional training; performance; crosstraining

Outcome Measures

Primary Outcomes (1)

• The effect of acute ingestion of the same dose of caffeine (3 mg/kg BM) in form of 3 different preparations on discipline-specific performance

  Total number of repetitions in Fight Gone Bad test and number or repetitions in rounds 1 - 3

  60 minutes after ingestion of tested supplements/placebo

Secondary Outcomes (7)

• The effect of acute ingestion of the same dose of caffeine (3 mg/kg BM) in form of 3 different preparations on blood and saliva caffeine and its metabolites levels

  Pre-ingestion and within 90 minutes after ingestion of tested supplements/placebo

• The effect of acute ingestion of the same dose of caffeine (3 mg/kg BM) in form of 3 different preparations on reaction time

  Pre-ingestion and within 90 minutes after ingestion of tested supplements/placebo

• The effect of acute ingestion of the same dose of caffeine (3 mg/kg BM) in form of 3 different preparations on postural stability

  Pre-ingestion and within 90 minutes after ingestion of tested supplements/placebo

• The effect of acute ingestion of the same dose of caffeine (3 mg/kg BM) in form of 3 different preparations on subjective levels/feelings of "energy", alertness, focus, fatigue

  Pre-ingestion and within 90 minutes after ingestion of tested supplements/placebo

• The effect of acute ingestion of the same dose of caffeine (3 mg/kg BM) in form of 3 different preparations on the Rate of Perceived Exertion (RPE)

  Pre-ingestion and within 90 minutes after ingestion of tested supplements/placebo

Study Arms (4)

CAFMONO supplementation

ACTIVE COMPARATOR

The experimental procedure for each participant assume random blind acute ingestion of CAFMONO in individual dose providing 3mg/kg BM of CAF at one of the study visits, which will be separated from other study visits with 7-days wash-out. The preparation will be provided in the form of powder and the individual doses of CAFMONO will be dissolved in 200 mL of water. The test preparation will be ingested within up to 5 minutes. The ingestion will take place 60 minutes before the test exercise.

Dietary Supplement: CAFMONO supplementation

CAFMIPS_1 supplementation

ACTIVE COMPARATOR

The experimental procedure for each participant assume random blind acute ingestion of CAFMIPS\_1 in individual dose providing 3mg/kg BM of CAF at one of the study visits, which will be separated from other study visits with 7-days wash-out. The preparation will be provided in the form of powder and the individual doses of CAFMIPS\_1 will be dissolved in 200 mL of water. The test preparation will be ingested within up to 5 minutes. The ingestion will take place 60 minutes before the test exercise.

Dietary Supplement: CAFMIPS_1 supplementation

CAFMIPS_2 supplementation

ACTIVE COMPARATOR

The experimental procedure for each participant assume random blind acute ingestion of CAFMIPS\_2 in individual dose providing 3mg/kg BM of CAF at one of the study visits, which will be separated from other study visits with 7-days wash-out. The preparation will be provided in the form of powder and the individual doses of CAFMIPS\_2 will be dissolved in 200 mL of water. The test preparation will be ingested within up to 5 minutes. The ingestion will take place 60 minutes before the test exercise.

Dietary Supplement: CAFMIPS_2 supplementation

Placebo treatment

PLACEBO COMPARATOR

The experimental procedure for each participant assume random blind acute ingestion of placebo (PLA) at one of the study visits, which will be separated from other study visits with 7-days wash-out. The PLA preparation will be provided in the form of powder and dissolved in 200 mL of water. PLA will be ingested within up to 5 minutes. The ingestion will take place 60 minutes before the test exercise.

Dietary Supplement: Placebo treatment

Interventions

CAFMONO supplementation DIETARY_SUPPLEMENT

CAFMONO supplementation - random blind acute intake of in individual dose providing 3mg/kg BM of CAF. CAFMONO - Caffeine (anhydrous caffeine), Ostrovit Sp. z o.o., Zambrów, POLAND

CAFMONO supplementation

CAFMIPS_1 supplementation DIETARY_SUPPLEMENT

CAFMIPS\_1 supplementation - random blind acute intake of in individual dose providing 3mg/kg BM of CAF. CAFMIPS\_1 - Olimp Redweiler, Olimp Laboratories Sp. z o.o., Dębica, POLAND CAFMIPS\_1 - Olimp Redweiler, Olimp Laboratories Sp. z o.o., Dębica, POLAND

CAFMIPS_1 supplementation

CAFMIPS_2 supplementation DIETARY_SUPPLEMENT

CAFMIPS\_2 supplementation - random blind acute intake of in individual dose providing 3mg/kg BM of CAF. CAFMIPS\_2 - Muscle Clinic Furious, Noblepharma UG, BerlinVertrieb, GERMANY.

CAFMIPS_2 supplementation

Placebo treatment DIETARY_SUPPLEMENT

Placebo treatment - random blind acute intake of placebo preparation. Placebo will match the remaining test preparations with taste, colour and consistency, however it will be free of caffeine and any other substances possessing ergogenic potential.

Placebo treatment

Eligibility Criteria

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

You may qualify if:

• written informed consent from all participants before the study,
• a current medical clearance to practice sports,
• training experience any sport discipline ≥ 5 years and training experience in HIFT ≥ 2 years,
• performing ≥3 training units per week,
• participating in CrossFit® competitions at least once a year.

You may not qualify if:

• current injury,
• any health-related contraindication,
• declared general feeling of being unwell,
• unwilling to follow the study protocol,
• serious disease or metabolic problems,
• smoking and tobacco use,
• presence of infectious disease in the previous 4 weeks of the study.

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• National Science Centre, Poland: collaborator
• Poznan University of Life Sciences: collaborator

Study Sites (1)

Department of Sports Dietetics, Poznan University of Physical Education

Poznan, 61-871, Poland

RECRUITING

Study Officials

• Krzysztof Durkalec-Michalski, Prof., PhD

  Department of Sports Dietetics, Poznan University of Physical Education

  STUDY CHAIR

• Paulina M Nowaczyk, PhD

  Department of Sports Dietetics, Poznan University of Physical Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof Durkalec-Michalski, Prof., PhD

CONTACT

+48 (61) 835 51 65; durkalec-michalski@awf.poznan.pl

Paulina M Nowaczyk, PhD

CONTACT

+48 (61) 835 53 71; nowaczyk@awf.poznan.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr hab., PhD

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: August 25, 2022
• Study Start: June 29, 2022
• Primary Completion: July 29, 2024
• Study Completion: July 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

PL (1)