Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000714785
Ethics application status
Approved
Date submitted
6/02/2022
Date registered
18/05/2022
Date last updated
18/05/2022
Date data sharing statement initially provided
18/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of NZ beetroot juice with UK beetroot juice supplementation on exercise performance, cognition, and cardiovascular function in recreationally trained exercisers
Scientific title
Comparison of NZ beetroot juice with UK beetroot juice supplementation on exercise performance, cognition, and cardiovascular function in recreationally trained exercisers
Secondary ID [1] 305517 0
Nil
Universal Trial Number (UTN)
Trial acronym
UK vs NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 323907 0
Exercise Performance 323908 0
Condition category
Condition code
Musculoskeletal 321424 321424 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The UKvNZ is a randomized controlled crossover trial designed to compare the benefits of juice from beetroot grown in NZ and UK following 7 days’ supplementation on exercise, cognitive performance, and cardiovascular function. Participants will come to the lab for four trials namely, familiarization trial, placebo, UK beetroot juice, and NZ beetroot juice trial.

During the familiarization trial participants will provide blood sample using venipuncture (baseline plasma nitrite/nitrate) and complete the maximal oxygen uptake (VO2max) test. After a 15min rest, they will complete a familiarization of the 4-km cycling time trial.

Participants will undertake 6 days’ supplementation after the familiarization trial (with one of the three drinks: placebo, UK beetroot juice drink or NZ beetroot juice drink) for each trial; on the 7th day, will be asked to come into the lab fasted. Participants will provide a finger prick blood sample and will consume breakfast and then undergo baseline tests. Participants will then consume assigned supplement and will wait for 2.5 h before completing the 120-minute cycling exercise at 70% of VO2max. This will be followed by the 4-km cycling time trial followed by the 4-km cycling time trial test. The test beverage will also be provided 60 min into the 120-minute exercise test. Outcome measures will be taken before, during and after the time trial. There will be a 7 days’ washout period after each trial.

Female participants taking contraceptive pills will be able to come in for the main trial during days 3-7 of their placebo; those not taking any contraceptives will be required to come during the early follicular phase (days 3-7); therefore, there will be longer duration between study visits for female participants.

Participants will be asked to return empty bottles after each 6-day supplementation period.

Trained phlebotomists will take blood samples through venepuncture during the trials. Research assistants trained in first aid will be present at all times to supervise all activities during the familiarization and main trial.

NZ beetroot juice contains 800mg nitrate/day; 200ml/day), UK beetroot juice - Beet-It contains 800mg nitrate/day; 200ml/day, and the placebo control contains 0mg nitrate/day; 200ml/day. Breakfast on the day of the trial will consist of a standardized isocaloric breakfast (cereal or toast) with the same macronutrient breakdown (15 g protein (22%), 30 g carbohydrates (45%) and 10 g fat (33%)) providing 270 Kcals.
Intervention code [1] 322787 0
Treatment: Other
Comparator / control treatment
Control treatment for beetroot juice will be a 200 ml drink containing minimal nitrate prepared with water, sugar, beetroot juice concentrate, and natural flavours
Control group
Placebo

Outcomes
Primary outcome [1] 330360 0
The main primary outcome is the 4-km time trial (TT) performance
Timepoint [1] 330360 0
Time taken to complete the 4-km TT as well as the mean watts throughout the 4-km TT
Primary outcome [2] 330361 0
Plasma nitrite levels will be assessed to evaluate the bioavailability of these compounds in the beverage
Timepoint [2] 330361 0
Blood samples (6ml; venepuncture) will be taken at the familiarization trial and during the main trial before the drink is ingested (-2.5h), immediately pre-exercise (0h), post-exercise (~1h) to assess plasma nitrate and nitrite.
Primary outcome [3] 330362 0
Plasma nitrate levels will be assessed to evaluate the bioavailability of these compounds in the beverage
Timepoint [3] 330362 0
Blood samples (6ml; venepuncture) will be taken at the familiarization trial and during the main trial before the drink is ingested (-2.5h), immediately pre-exercise (0h), post-exercise (~1h) to assess plasma nitrate and nitrite.
Secondary outcome [1] 405953 0
Ratings of perceived exertion will be evaluated as a part of the perceptual measures for the participants
Timepoint [1] 405953 0
Ratings of perceived exertion will be measured before (0 h), during (30 min intervals), and after the exercise test
Secondary outcome [2] 405954 0
Feeling scale will also be evaluated as part of the perceptual measures for the participants
Timepoint [2] 405954 0
The feeling scale will be measured before (0 h), during (30 min intervals), and after the exercise test.
Secondary outcome [3] 405955 0
The felt arousal scale will also be evaluated as part of the perceptual measures for the participants
Timepoint [3] 405955 0
The felt arousal scale will be measured before (0 h), during (30 min intervals), and after the exercise test (2.5 h).
Secondary outcome [4] 405957 0
Heart rate will be measured using a heart rate monitor.
Timepoint [4] 405957 0
Heart rate will be measured continuously during exercise

Eligibility
Key inclusion criteria
Participants must be proficient in English and must be between the ages of 18-45 years old. They should be well trained and be able to cycle at a moderate intensity for 120 min and also complete a 4 km timed trial.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
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 beetroot 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
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
GPower analysis of plasma nitrate data from Lansley et al (2011) and estimating a sample size of 12 using a standard deviation of 4.5 would give us a power of 0.80 at an alpha level of p<0.05. However, due to the potential for participant dropout, we aim to recruit 15 participants per group.

SPSS will be used for all data analyses

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2022
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 24545 0
New Zealand
State/province [1] 24545 0
Auckland

Funding & Sponsors
Funding source category [1] 309886 0
University
Name [1] 309886 0
Massey University Strategic Research Excellence Fund (SREF)
Country [1] 309886 0
New Zealand
Funding source category [2] 310717 0
University
Name [2] 310717 0
Massey University PreSeed Accelerator Fund (PSAF)
Country [2] 310717 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] 310913 0
None
Name [1] 310913 0
Address [1] 310913 0
Country [1] 310913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309610 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 309610 0
Ethics committee country [1] 309610 0
New Zealand
Date submitted for ethics approval [1] 309610 0
30/06/2021
Approval date [1] 309610 0
04/10/2021
Ethics approval number [1] 309610 0
SOA 21/36

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

Contacts
Principal investigator
Name 114762 0
Prof Ajmol Ali
Address 114762 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 114762 0
New Zealand
Phone 114762 0
+64 21 781 333
Fax 114762 0
Email 114762 0
[email protected]
Contact person for public queries
Name 114763 0
Ajmol Ali
Address 114763 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 114763 0
New Zealand
Phone 114763 0
+64 21 781 333
Fax 114763 0
Email 114763 0
[email protected]
Contact person for scientific queries
Name 114764 0
Ajmol Ali
Address 114764 0
Massey University - Albany
College of Sport, Exercise and Nutrition, SNW Extension Building
Private Bag 102 904 North Shore Auckland 0745
Country 114764 0
New Zealand
Phone 114764 0
+64 21 781 333
Fax 114764 0
Email 114764 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.