Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001394831
Ethics application status
Approved
Date submitted
25/08/2021
Date registered
15/10/2021
Date last updated
15/10/2021
Date data sharing statement initially provided
15/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Individual and additive effects of blackcurrant juice and caffeine intake on high-intensity intermittent exercise performance in physically active healthy male volunteers
Scientific title
Individual and additive effects of blackcurrant juice and caffeine intake on high-intensity intermittent exercise performance in physically active healthy male volunteers
Secondary ID [1] 305091 0
None
Universal Trial Number (UTN)
Trial acronym
2Before Study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Exercise performance 323309 0
Condition category
Condition code
Musculoskeletal 320874 320874 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 2Before study is a controlled, double-blind, crossover intervention trial in physically active healthy males (18-45 years), designed to examine the effect of caffeine and blackcurrant ingestion, provided before exercise to 15 previously physically fatigued male athletes, on various performance and metabolic parameters during a well-established running performance test (the Loughborough intermittent shuttle test - LIST).
Athletes will come to the lab for four main trials, with each trial taking place over two days: an initial fatiguing cycle exercise will be performed on day 1, followed by a running performance test on day 2. The fatiguing cycle exercise involves cycling at 30 min at 70% VO2max along with 3 x 50-s 'sprints' at double the resistive load (2 min rest in between each sprint) that is followed by 45 min at VO2max with a rated perceived exertion of 12-13 (20-point scale) (total duration approx. 85 minutes). Participants will perform the exercise 1 hour after the drink administration. For the LIST, the participants undertake shuttle running for 6 x 15-minutes (total duration 90 minutes) blocks of exercise at approx. 70%VO2max intensity. The running patterns are designed to mimic intermittent sport exercises (e.g., soccer, hockey) and include walking, sprinting, jogging, and running. The participants will also receive additional 5 x 3-minute rest periods interspersed within the exercise protocol, and the exercise will commence 1 hour after the drink administration.
The four main trials will explore four different conditions - Arm 1: Blackcurrant juice on day 1, and blackcurrant juice on day 2 (no caffeine) [blackcurrant, blackcurrant]; Arm 2: Placebo drink on day 1, and placebo drink containing 240mg caffeine on day 2 [placebo, caffeine]; Arm 3: Blackcurrant juice on day 1, and blackcurrant juice containing 240mg caffeine on day 2 [blackcurrant, blackcurrant + caffeine]; and Arm 4: Arm 2: Placebo drink on day 1, and placebo drink with no caffeine on day 2 [placebo, placebo].
The blackcurrant juice consists of blackcurrant juice concentrate (11g of blackcurrant powder containing 146 mg of anthocyanins), maltodextrin, monk fruit extract, and natural flavors. The blackcurrant juice concentrate will be mixed with water to form a solution of 75 ml, and it will then be given to the participant via drink bottles under staff supervision on day 1. Natural caffeine will be administered in the dose of 240 mg, and it will be mixed with blackcurrant juice on day 2 of the main trial under staff supervision. Participants will cycle (Day 1) and perform the LIST (day 2) in the presence of exercise scientists or the lab manager. Trained phlebotomists will take blood samples through cannulation (cycling) and venepuncture (LIST) during the trials. Research assistants trained in first aid will also be present at all times to supervise all activities during the familiarization and main trials. The washout period between trials will be at least 7 days.
Intervention code [1] 321485 0
Treatment: Other
Comparator / control treatment
Control treatment for blackcurrant juice will be a 75 ml drink made from combining maltodextrin, fructose, glucose, sucrose, citric acid, monk fruit extract, and natural flavors There will not be a specific control treatment for caffeine as the flavorings will mask the addition of any caffeine within the beverage. The control treatment (i.e. placebo arm) will involve administration of the 75ml placebo drink on both day 1 and day 2.
Control group
Placebo

Outcomes
Primary outcome [1] 328726 0
Distance covered during the Loughborough Intermittent Shuttle test will be assessed using the number of 20-meter laps completed
Timepoint [1] 328726 0
The assessment of distance covered during the Loughborough Intermittent Shuttle test will take place from the start time to the end (0 min to 85 - 90 mins)
Primary outcome [2] 328979 0
Sprint speed during the Loughborough Intermittent Shuttle test will be assessed using the number of 15-m sprints
Timepoint [2] 328979 0
The assessment of sprint speed during the Loughborough Intermittent Shuttle test will take place from the start time to the end (0 min to 85 - 90 mins) (i.e. approx 66 x 15-m sprints in total)
Primary outcome [3] 328980 0
Mean speed during the Loughborough Intermittent Shuttle test assessed using the number of 20 m laps completed
Timepoint [3] 328980 0
The assessment of mean speed during the Loughborough Intermittent Shuttle test will take place from the start time to the end (0 min to 85 - 90 mins).
Secondary outcome [1] 400133 0
We would also like to assess the effect of blackcurrant juice and caffeine on several oxidative markers through blood samples. The first oxidative marker would be malondialdehyde and would be assessed using ELISA kits.
Timepoint [1] 400133 0
Malondialdehyde will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [2] 401867 0
Protein Carbonyls will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on oxidative markers.
Timepoint [2] 401867 0
Protein carbonyls will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [3] 401868 0
Tumor Necrosis Factor-a will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on oxidative

Timepoint [3] 401868 0
Tumor Necrosis Factor-a will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [4] 401869 0
Interleukin-6 will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on oxidative markers through blood samples.
Timepoint [4] 401869 0
Interleukin-6 will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [5] 401870 0
Creatine Kinase will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on inflammation through blood samples
Timepoint [5] 401870 0
Creatine Kinase will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [6] 401871 0
Nuclear factor erythroid 2–related factor 2 (NRF2) will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on oxidative markers through blood samples
Timepoint [6] 401871 0
Nuclear factor erythroid 2–related factor 2 (NRF2) will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [7] 401872 0
Superoxide Dismutase will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on inflammation through blood samples
Timepoint [7] 401872 0
Superoxide Dismutase will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [8] 401873 0
Catalase will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on oxidative markers through blood samples
Timepoint [8] 401873 0
Catalase will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [9] 401874 0
Glutathione peroxidase and reduced (GSH) and oxidized (GSSG) Glutathione will also be assessed using ELISA kits to understand the effect of blackcurrant juice and caffeine on oxidative markers through blood samples
Timepoint [9] 401874 0
Glutathione peroxidase and reduced (GSH) and oxidized (GSSG) Glutathione will be assessed during cycling and LIST. Timepoints for cycling include Pre (0 min), during (30min), and immediately post (85 min), and for LIST include pre (0 min) and immediately post (90 min) LIST and 1h post (150 min) LIST
Secondary outcome [10] 401875 0
We would also like to assess caffeine genotype - ADORA2A through DNA extraction from the saliva and caffeine metabolites (caffeine, paraxanthine, theophylline, and theobromine) through blood using ELISA kits to understand caffeine metabolism in physically active individuals.
Timepoint [10] 401875 0
Caffeine metabolite ADORA2A will be assessed before supplementation (-60min before exercise), one hour after supplementation (0 min of exercise), and after the LIST (immediately post-exercise and 1 h post-exercise).
Secondary outcome [11] 401876 0
We would also like to assess caffeine genotype - CYP1A2 through DNA extraction from the saliva and caffeine metabolites (caffeine, paraxanthine, theophylline, and theobromine) through blood using ELISA kits to understand caffeine metabolism in physically active individuals.
Timepoint [11] 401876 0
Caffeine metabolite - CYP1A2 will be assessed before supplementation (-60min before exercise), one hour after supplementation (0 min of exercise), and after the LIST (immediately post-exercise and 1 h post-exercise).
Secondary outcome [12] 401877 0
In order to understand the effect of blackcurrant juice and caffeine on energy metabolism, we would like to assess the lactate levels in the blood. Blood lactate will be monitored through fingerpick and lactate strips.
Timepoint [12] 401877 0
Blood lactate and Free fatty acids will be assessed during cycling and LIST. Pre and post cycling; Before, during and immediately after LIST; 7 samples per trial (lactate);
Secondary outcome [13] 401878 0
In order to understand the effect of blackcurrant juice and caffeine on energy metabolism, we would also like to assess the free fatty acids in the blood. Free fatty acids will be evaluated from blood samples through ELISA kits.
Timepoint [13] 401878 0
Free fatty acids will be assessed during cycling and LIST. Pre and post cycling; Before, during and immediately after LIST; 5 samples per trial

Eligibility
Key inclusion criteria
Participants must be proficient in English and must be males between the ages of 18-45 years old. They should be well trained and be able to cycle at a moderate intensity for 90 min and also complete 90 min of high-intensity intermittent running (The LIST). They must be non-smokers and must pass health screening to perform the exercise. They should not be very heavy users of caffeine (>6mg/ kg/day) (barista coffee approx. 11.5mg/70kg) nor should be nonusers/caffeine naïve. Lastly, participants must have no known history of an adverse reaction to blackcurrant and/or other berry food products.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
individuals with a BMI of 30 kg/m2 and above or with a history of diabetes, cardiovascular disease, or hypertension will be excluded from the trial. Additionally, individuals with a known adverse reaction to caffeine and blackcurrant will also be excluded.

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 of the participants will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be established using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Calculations for subject size were conducted in G*Power (alpha level of 0.05, power of 0.80) and we estimated 12 participants will be required for our study. However, to account for any drop out we will therefore aim to recruit 15 athletes for this study.

SPSS will be used for all data analyses

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/08/2021
Date of last participant enrolment
Anticipated
10/11/2021
Actual
Date of last data collection
Anticipated
10/12/2021
Actual
Sample size
Target
15
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 24061 0
New Zealand
State/province [1] 24061 0
Auckland

Funding & Sponsors
Funding source category [1] 309490 0
Commercial sector/Industry
Name [1] 309490 0
Plant and Food Research
Country [1] 309490 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 310460 0
None
Name [1] 310460 0
Address [1] 310460 0
Country [1] 310460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309275 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 309275 0
Ethics committee country [1] 309275 0
New Zealand
Date submitted for ethics approval [1] 309275 0
23/02/2021
Approval date [1] 309275 0
23/03/2021
Ethics approval number [1] 309275 0
SOA 21/09

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

Contacts
Principal investigator
Name 113590 0
Prof Ajmol Ali
Address 113590 0
Massey University - Albany
College of Sport, Exercise, and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 113590 0
New Zealand
Phone 113590 0
+64 21 781 333
Fax 113590 0
Email 113590 0
[email protected]
Contact person for public queries
Name 113591 0
Ajmol Ali
Address 113591 0
Massey University - Albany
College of Sport, Exercise, and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 113591 0
New Zealand
Phone 113591 0
+64 21 781 333
Fax 113591 0
Email 113591 0
[email protected]
Contact person for scientific queries
Name 113592 0
Ajmol Ali
Address 113592 0
Massey University - Albany
College of Sport, Exercise, and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 113592 0
New Zealand
Phone 113592 0
+64 21 781 333
Fax 113592 0
Email 113592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial data will remain anonymised throughout the trial. No external researchers or databases will have access to individual data.


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.