Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000823774
Ethics application status
Approved
Date submitted
18/05/2022
Date registered
10/06/2022
Date last updated
10/06/2022
Date data sharing statement initially provided
10/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Individualization of caffeine supplementation in sports based on the analysis of heart rate variability (HRV)
Scientific title
Individualization of caffeine supplementation in adult athletes aged 18 to 30 based on the analysis of HRV
Secondary ID [1] 307153 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise performance 326353 0
Condition category
Condition code
Diet and Nutrition 323657 323657 0 0
Other diet and nutrition disorders
Musculoskeletal 323780 323780 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the study, caffeine consumption is investigated at a dosage of 3 (group A) and 6 mg/kg body weight (group B).
Caffeine will be administered orally in a single dose, based on body weight, in clear cellulose capsules (hydroxypropylmethylcellulose 100%).
Participants will be instructed to avoid foods containing caffeine for 24 hours prior to testing. All measurements will be taken between 8:00 am and 3:00 pm.
The caffeine dose will be randomly selected.
All measurements will be performed in university laboratories.
After ingestion of caffeine, participants will be continuously supervised until the end of the measurement and for the following 24 hours.
Intervention code [1] 323607 0
Treatment: Drugs
Comparator / control treatment
The control (placebo) group will be healthy volunteers.
Healthy volunteers will be asked to ingest the placebo before HRV measurements.
Placebo will be administered orally in a single dose, in clear cellulose capsules (hydroxypropylmethylcellulose 100%).
Participants will be instructed to avoid foods containing caffeine for 24 hours prior to testing. All measurements will be taken between 8:00 am and 3:00 pm.
The caffeine dose/ placebo will be randomly selected.
All measurements will be performed in university laboratories.
After ingestion of the placebo, all participants will be continuously supervised until the end of the measurement and for the following 24 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 331542 0
Changes in heart rate variability measured with a heart rate monitor.
Timepoint [1] 331542 0
rest - 0-20 minutes continuous measurements HRV
after administration of caffeine/placebo- 20-80 minutes continuous measurements HRV.
Primary outcome [2] 331543 0
Changes in muscle tension of the biceps femoris assessed with tensiomyography (TMG).
Timepoint [2] 331543 0
30 and 60 minutes after ingestion of 3 and 6 mg of caffeine or placebo
Secondary outcome [1] 409731 0
.Changes in plasma caffeine concentrations.
Timepoint [1] 409731 0
30 and 60 minutes after ingestion of 3 and 6 mg of caffeine

Eligibility
Key inclusion criteria
Healthy athletes and healthy volunteers
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• lack of informed consent to participate in research,
• hypersensitivity to caffeine due to the polymorphism of the CYP1A2 gene
• diseases of the cardiovascular system,
• chronic disease impairing the functioning of the musculoskeletal system,
• diabetes,
• epilepsy,
• pregnancy,
• infections,
• inflammatory diseases,
• stroke history,
• oncological diseases,
• electronic life support systems (pacemakers, active prostheses, etc.)
• use of preparations that interact with caffeine, i.e. ephedrine, theophylline, and echinacea
• hypertension (over 140/90 mmHg)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be centrally randomized by computer to the dose and time of evaluation. Before testing the patient is unaware of the dosage and time to be assessed. The dosage and evaluation are randomized by tossing a coin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using procedures coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size and effect size will be determined using the G*Power program following a pilot study. The statistical significance of the studied variables will be determined by the ANOVA test. Linear and logistic regression will be used to determine the major factors influencing caffeine metabolism.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 24779 0
Poland
State/province [1] 24779 0

Funding & Sponsors
Funding source category [1] 311456 0
University
Name [1] 311456 0
Poznan University of Medical Sciences
Country [1] 311456 0
Poland
Funding source category [2] 311457 0
University
Name [2] 311457 0
University of Opole
Country [2] 311457 0
Poland
Primary sponsor type
University
Name
Poznan University of Medical Sciences
Address
Fredry 10 61-701 Poznan, Poland
Country
Poland
Secondary sponsor category [1] 312853 0
University
Name [1] 312853 0
University of Opole
Address [1] 312853 0
pl. Kopernika 11a
45-040 Opole
Poland
Country [1] 312853 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310928 0
Ethics Committee of Poznan University of Medical Sciences
Ethics committee address [1] 310928 0
Ethics committee country [1] 310928 0
Poland
Date submitted for ethics approval [1] 310928 0
24/02/2022
Approval date [1] 310928 0
10/03/2022
Ethics approval number [1] 310928 0
108/22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119382 0
Dr Przemyslaw Domaszewski
Address 119382 0
Wydzial Nauk o Zdrowiu, uniwersytet Opolski
ul. Katowicka 68, 45-060 Opole
Country 119382 0
Poland
Phone 119382 0
+48 77 44 23 510
Fax 119382 0
+48 77 541 6000
Email 119382 0
[email protected]
Contact person for public queries
Name 119383 0
Przemyslaw Domaszewski
Address 119383 0
Wydzial Nauk o Zdrowiu Uniwersytet Opolski
ul. Katowicka 68, 45-060 Opole
Country 119383 0
Poland
Phone 119383 0
+48 77 44 23 510
Fax 119383 0
+48 77 541 6000
Email 119383 0
[email protected]
Contact person for scientific queries
Name 119384 0
Przemyslaw Domaszewski
Address 119384 0
Wydzial Nauk o Zdrowiu Uniwersytet Opolski
ul. Katowicka 68, 45-060 Opole
Country 119384 0
Poland
Phone 119384 0
+48 77 44 23 510
Fax 119384 0
+48 77 541 6000
Email 119384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All raw data will be shared via an external drive
When will data be available (start and end dates)?
The data will be available for 5 years after the conclusion of the study.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
For any purpose
How or where can data be obtained?
Access is subject to approvals by [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.