Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001466235
Ethics application status
Approved
Date submitted
27/08/2018
Date registered
31/08/2018
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Date results provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of single-dose beetroot juice on the blood pressure and cognition of healthy older versus younger adult
Scientific title
The effect of acute beetroot juice supplementation on the cardiovascular and cognition function of healthy older versus younger adult
Secondary ID [1] 295901 0
None
Universal Trial Number (UTN)
Trial acronym
TBJP (The Beetroot Juice Project)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Blood Pressure 309370 0
Cognitive decline
 309371 0
Condition category
Condition code
Cardiovascular 308232 308232 0 0
Hypertension
Neurological 308267 308267 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Beetroot intervention:
One bottle (150ml) of nitrate-rich beetroot juice (10.5 mmol nitrate) consumed acutely 2.25 hours prior to repeating testing and 2.5 hr prior to 30 minutes of walking exercise at moderate intensity (defined as a 3 on the Borg RPE 10-point scale).
Intervention adherence will be controlled for by observing participants consume the drink in the laboratory
Wash out period between trial was one week
Intervention code [1] 312226 0
Treatment: Other
Intervention code [2] 312269 0
Other interventions
Comparator / control treatment
Placebo control:
One bottle (150ml) of nitrate-depleted beetroot juice (1 mmol nitrate) acutely, 2,25 hours prior to retesting and 2.5 hr prior to exercise. This will be done in a randomised crossover design.
Intervention adherence again will be controlled for by observing participants consume the drink in the laboratory
Control group
Placebo

Outcomes
Primary outcome [1] 307199 0
Change in blood pressure (Average of three resting blood pressure measures using an OMRON automatic blood pressure machine)
Timepoint [1] 307199 0
Before versus 2.25 hours after consumption of beetroot juice (Primary measure) and post-exercise.
Primary outcome [2] 307200 0
Plasma nitrate concentrations (via blood sample analysis with HPLC)
Timepoint [2] 307200 0
Before versus 2.25 hours after consumption of beetroot juice (primary measure) and post-exercise test
Primary outcome [3] 307230 0
Plasma nitrite concentrations (via blood sample analysis with HPLC)
Timepoint [3] 307230 0
Before versus 2.25 hours after consumption of beetroot juice (primary measure) and post-exercise test
Secondary outcome [1] 351100 0
Cognitive performance (via three cognitive tests; choice reaction test, rapid visual information processing test and Stroop test); this was a composite secondary outcome
Timepoint [1] 351100 0
Before versus 2.25 hours after consumption of beetroot juice
Secondary outcome [2] 351101 0
Cardiovascular performance (from oxygen uptake measured using Douglas bags)
Timepoint [2] 351101 0
First 5 min during 30 minute walking test
Secondary outcome [3] 351102 0
Mood and perception (using feeling scale, felt arousal scale, profile of mood states, and rating of perceived exertion scale); this was a composite secondary outcome
Timepoint [3] 351102 0
Before versus 2.25 hours after consumption of beetroot juice and during 30 minute walking test

Eligibility
Key inclusion criteria
Between the ages of 18 - 30y or 50 - 70y
Able to walk at moderate intensity for 30 min
Healthy individuals
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Advanced/elite athletes (someone who trains more than four times per week constantly for their sport and competes at a high level)
Taking blood pressure medication

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation 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
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted (G-Power 3.1) to calculate sample size based on the primary measure of blood pressure. Previous literature in healthy adults has shown a mean change in BP of 10 mmHg (9 SD) between BR and control. Based on this, the required sample size was 11 per group, using a SD of 9, with a statistical power of 0.82 and a-level set at 0.05.

The data were analysed using mixed-method repeated-measures analysis of variance (ANOVA) with treatment and time as within-subject factors, and age as the between-subject factor. Sphericity was tested using the Mauchly’s test to ensure the assumption of sphericity was not violated, and multivariate models were applied if these assumptions were not met. Where significant differences were found, post-hoc tests with Holm-Bonferroni correction were undertaken to assess multiple comparisons. Outliers were excluded based on the Tukey test. Data are presented as mean ± standard deviation. Statistical significance was set at P<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/08/2016
Date of last participant enrolment
Anticipated
Actual
24/10/2017
Date of last data collection
Anticipated
Actual
11/11/2017
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 20798 0
New Zealand
State/province [1] 20798 0
Auckland

Funding & Sponsors
Funding source category [1] 300491 0
University
Name [1] 300491 0
Massey University, Auckland
Country [1] 300491 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
School of Sport, Exercise and Nutrition, East Precinct, Dairy Flat Highway (SH17), Albany, Auckland, 0632
Country
New Zealand
Secondary sponsor category [1] 299981 0
None
Name [1] 299981 0
Address [1] 299981 0
Country [1] 299981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301291 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 301291 0
Ethics committee country [1] 301291 0
New Zealand
Date submitted for ethics approval [1] 301291 0
18/04/2016
Approval date [1] 301291 0
07/07/2016
Ethics approval number [1] 301291 0
SOA 16/27

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

Contacts
Principal investigator
Name 86514 0
Mr Luke Stanaway
Address 86514 0
School of Sport, Exercise and Nutrition | College of Health
Massey University | Private Bag 102904 | North Shore Mail Centre | Auckland | 0745
Country 86514 0
New Zealand
Phone 86514 0
+642102965220
Fax 86514 0
Email 86514 0
[email protected]
Contact person for public queries
Name 86515 0
Ajmol Ali
Address 86515 0
School of Sport, Exercise and Nutrition | College of Health
Massey University | Private Bag 102904 | North Shore Mail Centre | Auckland | 0745
Country 86515 0
New Zealand
Phone 86515 0
+64 9 213 6414
Fax 86515 0
Email 86515 0
[email protected]
Contact person for scientific queries
Name 86516 0
Ajmol Ali
Address 86516 0
School of Sport, Exercise and Nutrition | College of Health
Massey University | Private Bag 102904 | North Shore Mail Centre | Auckland | 0745
Country 86516 0
New Zealand
Phone 86516 0
+64 9 213 6414
Fax 86516 0
Email 86516 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


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
SourceTitleYear of PublicationDOI
EmbaseAcute supplementation with nitrate-rich beetroot juice causes a greater increase in plasma nitrite and reduction in blood pressure of older compared to younger adults.2019https://dx.doi.org/10.3390/nu11071683
N.B. These documents automatically identified may not have been verified by the study sponsor.