Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001308886
Ethics application status
Approved
Date submitted
22/01/2021
Date registered
27/09/2021
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the timing of low-dose caffeine on 3-point shooting accuracy in college basketball players.
Scientific title
Effect of the timing of low-dose caffeine (3mg/kg body mass) on 3-point shooting accuracy in college basketball players.
Secondary ID [1] 303247 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal fitness 320428 0
Condition category
Condition code
Musculoskeletal 318321 318321 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The entire duration of the study will last 3 weeks. Each participant will undertake 3 visits (trials) in a randomised, counterbalanced, crossover, controlled design. Each visit will be conducted on the same day over 3 weeks, e.g. Monday of Week 1 to 3. Thus, there will be a washout period of 7 days between visits. For each visit, 2 pills containing either caffeine or placebo will be provided before a standardised basketball simulation test and shooting protocol conducted over four quarters of 10 minutes. The ingestion of the first pill for each visit will be 75 minutes before the start of the basketball simulation test while the ingestion of the second pill for each visit will be 15 minutes prior to the basketball simulation test. The ingestion of the pills provided will be supervised by the investigators to ensure adherence to intervention.

Timing of low-dose caffeine (3mg/kg body mass) with 3 visits:
(a) placebo and placebo
(b) caffeine and placebo
(c) placebo and caffeine

Drug: Caffeine (99% concentration) from BulkPowders, United Kingdom.
Dose: 3mg/kg of body mass.
Duration: For visits (b) and (c), administered once per visit.
Mode of administration: opaque and unidentifiable oral capsules.
Intervention code [1] 319552 0
Treatment: Drugs
Intervention code [2] 319553 0
Treatment: Other
Comparator / control treatment
Placebo (control)
Drug: Maltodextrin (100% concentration) from BulkPowders, United Kingdom.
Dose: 3mg/kg of body mass.
Duration: For visit (a), administered twice. For visits (b) and (c), administered once per visit as the other pill ingested will be the intervention provided.
Mode of administration: opaque and unidentifiable oral capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 326292 0
Effect of the timing of low-dose caffeine ingestion on 3-point shooting performance in basketball using a binary scale (0 for miss and 1 for score).
Timepoint [1] 326292 0
For the first pill, shooting performance will be taken:
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 134 mins post-dose (primary endpoint)

For the second pill, shooting performance will be taken:
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post dose
- 74 mins post-dose
Secondary outcome [1] 390930 0
Heart rate using Polar H7
Timepoint [1] 390930 0
For the first pill, heart rate will be taken:
- 15 mins post-dose
- 30 mins post-dose
- 45 mins post-dose
- 60 mins post-dose
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 134 mins post-dose

For the second pill, heart rate will be taken:
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post-dose
- 74 mins post-dose
Secondary outcome [2] 390931 0
Rating of perceived exertion (RPE) using a 6-20 Borg scale
Timepoint [2] 390931 0
For first pill, RPE will be taken:
- 15 mins post dose
- 30 mins post dose
- 45 mins post dose
- 60 mins post dose
- 85 mins post dose
- 97 mins post dose
- 122 mins post dose
- 134 mins post dose

For second pill, RPE will be taken:
- 25 mins post dose
- 37 mins post dose
- 62 mins post dose
- 74 mins post dose
Secondary outcome [3] 390932 0
Sprint performance using SpeedLight Timing Gates
Timepoint [3] 390932 0
16 measurements per 8 minutes of exercise for 4 sets in one main trial.
For the first pill, sprint performance will be taken every 30 seconds from 75-83 mins, 87.5-95 mins, 112.5-120 mins, and 124-131.5 mins post-dose.

For the second pill, sprint performance will be taken every 30 seconds from 15.5-23 mins, 27.5-35 mins, 52.5-60 mins, and 64.5-72 mins post-dose.
Secondary outcome [4] 390933 0
Vertical jump height measured using Vertec
Timepoint [4] 390933 0
16 measurements per 8 minutes of exercise for 4 sets in one main trial.
For the first pill, vertical jump height will be taken every 30 seconds from 75-83 mins, 87.5-95 mins, 112.5-120 mins, and 124-131.5 mins post-dose.

For the second pill, vertical jump height will be taken every 30 seconds from 15.5-23 mins, 27.5-35 mins, 52.5-60 mins, and 64.5-72 mins post-dose.
Secondary outcome [5] 390934 0
Circuit completion timing measured using SpeedLight Timing Gates
Timepoint [5] 390934 0
16 measurements per 8 minutes of exercise for 4 sets in one main trial.
For the first pill, circuit completion timing will be taken every 30 seconds from 75-83 mins, 87.5-95 mins, 112.5-120 mins, and 124-131.5 mins post-dose.

For the second pill, circuit completion timing will be taken every 30 seconds from 15.5-23 mins, 27.5-35 mins, 52.5-60 mins, and 64.5-72 mins post-dose.
Secondary outcome [6] 390935 0
Blood glucose measured using Accu-Chek
Timepoint [6] 390935 0
For the first pill, blood glucose will be taken:
- 60 mins post-dose
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 134 mins post-dose

For the second pill, blood glucose will be taken:
- Immediately after ingestion
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post-dose
- 74 mins post-dose
Secondary outcome [7] 390936 0
Blood lactate measured using Lactate Pro 2
Timepoint [7] 390936 0
For the first pill, blood lactate will be taken:
- 60 mins post-dose
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 134 mins post-dose

For the second pill, blood lactate will be taken:
- Immediately after ingestion
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post-dose
- 74 mins post-dose
Secondary outcome [8] 390937 0
Self-confidence measured using a single item questionnaire (11-point Likert scale)
Timepoint [8] 390937 0
For the first pill, self-confidence will be taken:
- Immediately after ingestion
- 60 mins post-dose
- 75 mins post-dose
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 149 mins post-dose

For the second pill, self-confidence will be taken:
- Immediately after ingestion
- 15 mins post-dose
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post-dose
- 89 mins post-dose
Secondary outcome [9] 390938 0
Motivation measured using a single-item questionnaire (11-point Likert scale)
Timepoint [9] 390938 0
For the first pill, motivation will be taken:
- Immediately after ingestion
- 60 mins post-dose
- 75 mins post-dose
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 149 mins post-dose

For the second pill, motivation will be taken:
- Immediately after ingestion
- 15 mins post-dose
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post-dose
- 89 mins post-dose
Secondary outcome [10] 390939 0
Feeling and felt-arousal measured using the circumplex Feeling and Felt Arousal Scale
Timepoint [10] 390939 0
For the first pill, feeling and felt arousal will be taken:
- Immediately after ingestion
- 60 mins post-dose
- 75 mins post-dose
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 149 mins post-dose

For the second pill, feeling and felt arousal will be taken:
- Immediately after ingestion
- 15 mins post-dose
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post-dose
- 89 mins post-dose
Secondary outcome [11] 390940 0
Aggression measured using a single-item questionnaire (11-point Likert scale)
Timepoint [11] 390940 0
For the first pill, aggression will be taken:
- Immediately after ingestion
- 60 mins post-dose
- 75 mins post-dose
- 85 mins post-dose
- 97 mins post-dose
- 122 mins post-dose
- 149 mins post-dose

For the second pill, aggression will be taken:
- Immediately after ingestion
- 15 mins post-dose
- 25 mins post-dose
- 37 mins post-dose
- 62 mins post-dose
- 89 mins post-dose

Eligibility
Key inclusion criteria
1) Male
2) Aged between 21 to 30 years old
3) Have no known caffeine allergy/intolerance
4) Competed in at least one university level basketball tournament or equivalent
5) Have at least 3 years of prior basketball experience in both training and competing
6) Have no health conditions diagnosed by a medical doctor preventing exercise participation
7) Not be taking any medications for chronic medical conditions
8) Have no self-reported medical conditions (e.g. hypertension, cardiovascular disease, insomnia and frequent migraines)
9) Consume between 0mg to 200mg of caffeine per day
10) Not be using any supplements that may have a physiological or psychological effect on the body (e.g. psychostimulant drugs, diuretic drugs or hormone containing supplements)
11) Be injury-free in the previous two months
Minimum age
21 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any diagnosed form of cardiometabolic disease (CVD, diabetes, metabolic syndrome, hypertension)
2) Any symptoms that are contraindication of exercise testing (e.g. chest pains)
3) Any balance or dizziness problems
4) Any chronic medical conditions (and also whether it is medicated or not)
5) Any medical doctor diagnosed to contraindications to exercise
6) If you drink alcohol more than 3 times each week and more than 3 drinks each time
7) Any allergies or intolerance to caffeine
8) Failed to score less than 15% 3-point shooting accuracy during the familiarisation trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power analysis was conducted using G*Power 3.1 to address the primary research question. Using a repeated measure Analysis of Variance (ANOVA) with one group and three measurements, 18 participants will be required to elicit a statistical power of 0.95, a moderate effect size (f) of 0.40 with alpha (p-value) of 0.05.

A one-way repeated measures ANOVA will be conducted to compare for differences in 3-point shooting performance among the 3 different conditions. Two-way ANOVA will be used for secondary outcomes to measures differences among trials and over time. Bonferroni post-hoc t-test will be applied when any significant effect from the ANOVA is found.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/12/2020
Date of last participant enrolment
Anticipated
Actual
29/07/2021
Date of last data collection
Anticipated
Actual
12/08/2021
Sample size
Target
18
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 23403 0
Singapore
State/province [1] 23403 0

Funding & Sponsors
Funding source category [1] 307657 0
University
Name [1] 307657 0
National Institute of Education, Nanyang Technological University
Country [1] 307657 0
Singapore
Primary sponsor type
University
Name
National Institute of Education, Nanyang Technological University
Address
1 Nanyang Walk, Singapore 637616
Country
Singapore
Secondary sponsor category [1] 308351 0
None
Name [1] 308351 0
NIL
Address [1] 308351 0
NIL
Country [1] 308351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307695 0
Nanyang Technological University Institutional Review Board
Ethics committee address [1] 307695 0
Ethics committee country [1] 307695 0
Singapore
Date submitted for ethics approval [1] 307695 0
11/09/2020
Approval date [1] 307695 0
07/12/2020
Ethics approval number [1] 307695 0
IRB-2020-09-043

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

Contacts
Principal investigator
Name 108174 0
A/Prof Stephen Francis Burns
Address 108174 0
Physical Education and Sport Science
National Institute of Education
Nanyang Technological University
1 Nanyang Walk, Singapore 637616
Country 108174 0
Singapore
Phone 108174 0
+6562196214
Fax 108174 0
Email 108174 0
[email protected]
Contact person for public queries
Name 108175 0
Stephen Francis Burns
Address 108175 0
Physical Education and Sport Science
National Institute of Education
Nanyang Technological University
1 Nanyang Walk, Singapore 637616
Country 108175 0
Singapore
Phone 108175 0
+6562196214
Fax 108175 0
Email 108175 0
[email protected]
Contact person for scientific queries
Name 108176 0
Stephen Francis Burns
Address 108176 0
Physical Education and Sport Science
National Institute of Education
Nanyang Technological University
1 Nanyang Walk, Singapore 637616
Country 108176 0
Singapore
Phone 108176 0
+6562196214
Fax 108176 0
Email 108176 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?
Individual participant data underlying published results.
When will data be available (start and end dates)?
Beginning immediately after main results publication and make available for 10 years.
Available to whom?
Upon reasonable request on a case-by-case basis to the Principal Investigator.
Available for what types of analyses?
Meta-analyses in the area of the primary and secondary research outcomes.
How or where can data be obtained?
Data related to any publication will be placed in the National Institute of Education Data Repository for 10 years after the publication date and will be made available on a case-by-case basis upon reasonable request to the Principal Investigator at: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10326Ethical approval  [email protected]
10327Informed consent form  [email protected]



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.