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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]

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

Cognitive decline

Condition category

Condition code

Cardiovascular

Hypertension

Neurological

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]

Treatment: Other

Intervention code [2]

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]

Change in blood pressure (Average of three resting blood pressure measures using an OMRON automatic blood pressure machine)

Timepoint [1]

Before versus 2.25 hours after consumption of beetroot juice (Primary measure) and post-exercise.

Primary outcome [2]

Plasma nitrate concentrations (via blood sample analysis with HPLC)

Timepoint [2]

Before versus 2.25 hours after consumption of beetroot juice (primary measure) and post-exercise test

Primary outcome [3]

Plasma nitrite concentrations (via blood sample analysis with HPLC)

Timepoint [3]

Before versus 2.25 hours after consumption of beetroot juice (primary measure) and post-exercise test

Secondary outcome [1]

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]

Before versus 2.25 hours after consumption of beetroot juice

Secondary outcome [2]

Cardiovascular performance (from oxygen uptake measured using Douglas bags)

Timepoint [2]

First 5 min during 30 minute walking test

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Massey University, Auckland

Address [1]

Massey University East Precinct, Dairy Flat Highway (SH17), Albany, Auckland, 0632

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Massey University Human Ethics Committee: Human Ethics Southern A Committee

Ethics committee address [1]

Massey University Human Ethics Committee, Massey University, Private Bag 11 222 | Palmerston North 4442 | New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

18/04/2016

Approval date [1]

07/07/2016

Ethics approval number [1]

SOA 16/27

Summary

Brief summary

In today's society, rates of disease and age-related dysfunction continue to grow at a rapid speed. This has led to an increased interest in the use of food-based supplements such as beetroot juice. Beetroot juice contains nitrate and has been shown to reduce blood pressure, improve cardiovascular function and improve exercise performance. Furthermore, recent evidence has indicated that increased nitric oxide (the bio-active form of nitrate) may have effects on increased blood flow to the brain leading to improved cognition and mood in older adults. However, research in this area is limited and few studies have looked at the effects of beetroot juice when comparing younger and older adults. 

Overall aim:
Therefore, the aim of this study is to examine the effects of acute nitrate supplementation, from beetroot juice as a breakfast food, on cognition, mood and cardiovascular responses in younger (18-30) versus older adults (50-70).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Luke Stanaway

Address

Country

New Zealand

Phone

+642102965220

Fax

l.stanaway@massey.ac.nz

Contact person for public queries

Name

Ajmol Ali

Address

Country

New Zealand

Phone

+64 9 213 6414

Fax

a.ali@massey.ac.nz

Contact person for scientific queries

Name

Ajmol Ali

Address

Country

New Zealand

Phone

+64 9 213 6414

Fax

a.ali@massey.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Acute supplementation with nitrate-rich beetroot juice causes a greater increase in plasma nitrite and reduction in blood pressure of older compared to younger adults.	2019	https://dx.doi.org/10.3390/nu11071683

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically