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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]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Musculoskeletal fitness

Condition category

Condition code

Musculoskeletal

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]

Treatment: Drugs

Intervention code [2]

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]

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]

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]

Heart rate using Polar H7

Timepoint [1]

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]

Rating of perceived exertion (RPE) using a 6-20 Borg scale

Timepoint [2]

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]

Sprint performance using SpeedLight Timing Gates

Timepoint [3]

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]

Vertical jump height measured using Vertec

Timepoint [4]

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]

Circuit completion timing measured using SpeedLight Timing Gates

Timepoint [5]

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]

Blood glucose measured using Accu-Chek

Timepoint [6]

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]

Blood lactate measured using Lactate Pro 2

Timepoint [7]

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]

Self-confidence measured using a single item questionnaire (11-point Likert scale)

Timepoint [8]

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]

Motivation measured using a single-item questionnaire (11-point Likert scale)

Timepoint [9]

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]

Feeling and felt-arousal measured using the circumplex Feeling and Felt Arousal Scale

Timepoint [10]

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]

Aggression measured using a single-item questionnaire (11-point Likert scale)

Timepoint [11]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Singapore

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

National Institute of Education, Nanyang Technological University

Address [1]

1 Nanyang Walk, Singapore 637616

Country [1]

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]

None

Name [1]

NIL

Address [1]

NIL

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Nanyang Technological University Institutional Review Board

Ethics committee address [1]

Research Integrity and Ethics Office
62 Nanyang Drive
Block N1.2, B1-02A
Singapore 637459

Ethics committee country [1]

Singapore

Date submitted for ethics approval [1]

11/09/2020

Approval date [1]

07/12/2020

Ethics approval number [1]

IRB-2020-09-043

Summary

Brief summary

Caffeine is a well-known ergogenic aid used by many athletes. It has been found that caffeine is beneficial in improving different elements of sports performance such as endurance performance, sprint performance and even vertical jump height. However, inconsistent results were found for caffeine and accuracy-based tasks in sports. In basketball, 3-point shooting accuracy is a key indicator to winning games. It is, therefore, valuable to identify interventions that will improve 3-point shooting performance in basketball games. We are asking you to take part in the present study as we want to identify whether caffeine will provide any benefits to improving 3-point shooting performance after completing an exercise protocol. You are considered one of those athletes. 

Thus, this investigational study is carried out to find out the effects of low-dose caffeine ingestion and timing on 3-point shooting accuracy in college basketball players. This study will also explore: (a) the effects of low-dose caffeine ingestion and timing on vertical jump height, sprint performance and completion timing of the exercise protocol, (b) effects of caffeine on heart rate, rate of perceived exertion, blood glucose, blood lactate, self-confidence, motivation, feeling, felt arousal and aggression, (c) relationship of heart rate, rate of perceived exertion, blood glucose, blood lactate, self-confidence, motivation, feeling, felt arousal and aggression with 3-point shooting performance in basketball.

Trial website

NIL

Trial related presentations / publications

NIL

Public notes

NIL

Contacts

Principal investigator

Name

A/Prof Stephen Francis Burns

Address

Physical Education and Sport Science
National Institute of Education
Nanyang Technological University
1 Nanyang Walk, Singapore 637616

Country

Singapore

Phone

+6562196214

Fax

stephen.burns@nie.edu.sg

Contact person for public queries

Name

Stephen Francis Burns

Address

Physical Education and Sport Science
National Institute of Education
Nanyang Technological University
1 Nanyang Walk, Singapore 637616

Country

Singapore

Phone

+6562196214

Fax

stephen.burns@nie.edu.sg

Contact person for scientific queries

Name

Stephen Francis Burns

Address

Physical Education and Sport Science
National Institute of Education
Nanyang Technological University
1 Nanyang Walk, Singapore 637616

Country

Singapore

Phone

+6562196214

Fax

stephen.burns@nie.edu.sg

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: stephen.burns@nie.edu.sg

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10326	Ethical approval			stephen.burns@nie.edu.sg
10327	Informed consent form			stephen.burns@nie.edu.sg

Results publications and other study-related documents

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No additional documents have been identified.

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