Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001608459
Ethics application status
Approved
Date submitted
9/11/2016
Date registered
21/11/2016
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A glass of beetroot juice a day beats the exercise blues?
Scientific title
Beetroot supplementation and exercise tolerance in obese individuals: another way to boost physical activity to combat obesity?
Secondary ID [1] 290498 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 300888 0
Heart Disease 300889 0
Condition category
Condition code
Cardiovascular 300708 300708 0 0
Other cardiovascular diseases
Diet and Nutrition 300709 300709 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dietary nitrate supplementation in the form of beetroot juice, equivalent to 15mmol/L nitrate daily for 8 weeks. Overall intake will be approx. 250ml daily. Juice composition will be 72% beetroot and 28% apple juice.

Subjects otherwise will maintain their normal diet and exercise regimens.

The trial will be conducted at the John Hunter Hospital, NSW, Australia by the principal investigators:
1. A/Prof Aaron Sverdlov - Senior Consultant Cardiologist, Director of Heart Failure
2. A/Prof Doan Ngo - Senior Research Fellow, Associate Professor, University of Newcastle; Pharmacist

Obese individuals (BMI greater or equal to 30kg/m2), aged ranging 20-60 years with no history of heart disease, or diabetes who are not on a regular exercise regime will be randomized into 2 groups: beetroot juice supplementation (Group A, 25 participants) vs. identical nitrate-depleted placebo (Group B, 25 participants) daily for 8 weeks. Subjects in both groups will be matched for age, gender and BMI.

The active juice and the placebo will be provided by the investigators.

Adherence will be monitored using food diary, provided to the participants.
Intervention code [1] 296355 0
Treatment: Other
Comparator / control treatment
Placebo juice will consist of an apple juice concentrate base matched to the beetroot juice for sweetness and colour. Randomization to placebo will be on 1:1 basis
Control group
Placebo

Outcomes
Primary outcome [1] 300126 0
The primary end-point will be the impact of beetroot juice on exercise capacity, assessed by Maximal-Effort Cardiopulmonary Exercise Test and a Constant-Intensity Protocol Cardiopulmonary Exercise Test
Timepoint [1] 300126 0
8 weeks post commencement
Secondary outcome [1] 329117 0
Secondary outcomes will assess impact of beetroot juice supplementation on markers of insulin sensitivity and glucose homeostasis (composite) assessed on blood tests
Timepoint [1] 329117 0
8 weeks post commencement
Secondary outcome [2] 329118 0
Secondary outcomes will assess impact of beetroot juice supplementation on markers of endothelial function assessed by applanation tonometry
Timepoint [2] 329118 0
8 weeks post commencement
Secondary outcome [3] 329119 0
Secondary outcomes will assess impact of beetroot juice supplementation on skeletal muscle mitochondrial function. Small sample of skeletal muscle will be obtained by fine needle biopsy, mitochondria will be isolated and function measured as described by Sverdlov et al, J Am Heart Assoc 2016; 5(1). pii: e002555
Timepoint [3] 329119 0
8 weeks post commencement
Secondary outcome [4] 329494 0
Secondary outcomes will assess impact of beetroot juice supplementation on markers of inflammation assessed on blood tests
Timepoint [4] 329494 0
8 weeks post commencement

Eligibility
Key inclusion criteria
Males and females
BMI greater or equal to 30kg/m2
20 to 60 years of age
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unable to provide written informed consent to participate in this study
2. Individuals who are receiving current anti-platelet therapy,
3. Known diabetes mellitus and the use of medication that might affect blood pressure, glucose or lipid metabolism will be excluded
4. Known heart disease
5. Concomitant conditions potentially limiting exercise capacity (eg peripheral vascular disease, respiratory, neuromuscular or orthopaedic disease states).

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)
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
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary and secondary end points between the nitrite (beetroot) and placebo treated groups will be compared using unpaired t test for normally distributed data or the Wilcoxon signed-rank test for non-parametric data. Correlations between exercise duration and plasma nitrate/nitrite, HOMA-IR, fasting glucose, weight loss, and endothelial function measurements will be performed using linear regression analyses. A value of P<0.05 will be considered significant.

(v) Power calculations: As recently shown, beetroot juice supplementation significantly improved exercise duration in heart failure patients with a mean difference 0.8 +/- 1.3 minutes in exercise duration; P=0.02, n=17 patients (Zamani P, Rawat D, Shiva-Kumar P, et al. Circulation 2015;131:371-80). Therefore, a sample size of 24 patients in each group: beetroot juice vs placebo, unpaired t-test will give us 80% power with a=0.05 to detect 1.25SD difference in exercise duration.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2017
Actual
1/12/2017
Date of last participant enrolment
Anticipated
30/11/2018
Actual
8/11/2018
Date of last data collection
Anticipated
30/01/2019
Actual
30/01/2019
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9432 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 18144 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 294917 0
Charities/Societies/Foundations
Name [1] 294917 0
Heart Foundation of Australia
Country [1] 294917 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road
New Lambton
NSW 2305
Country
Australia
Secondary sponsor category [1] 293751 0
None
Name [1] 293751 0
Address [1] 293751 0
Country [1] 293751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299088 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299088 0
Ethics committee country [1] 299088 0
Australia
Date submitted for ethics approval [1] 299088 0
01/10/2017
Approval date [1] 299088 0
Ethics approval number [1] 299088 0
UoNSSA2018-01
Ethics committee name [2] 308708 0
HUMAN RESEARCH ETHICS COMMITTEE - University of Newcastle
Ethics committee address [2] 308708 0
Ethics committee country [2] 308708 0
Australia
Date submitted for ethics approval [2] 308708 0
14/09/2017
Approval date [2] 308708 0
22/11/2017
Ethics approval number [2] 308708 0
H-2017-0315

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

Contacts
Principal investigator
Name 70302 0
A/Prof Aaron Sverdlov
Address 70302 0
Cardiovascular Department
John Hunter Hospital
Lookout Road
New Lambton NSW 2305
Country 70302 0
Australia
Phone 70302 0
+61249214202
Fax 70302 0
Email 70302 0
[email protected]
Contact person for public queries
Name 70303 0
Aaron Sverdlov
Address 70303 0
Cardiovascular Department
John Hunter Hospital
Lookout Road
New Lambton NSW 2305
Country 70303 0
Australia
Phone 70303 0
+61249214202
Fax 70303 0
Email 70303 0
[email protected]
Contact person for scientific queries
Name 70304 0
Aaron Sverdlov
Address 70304 0
Cardiovascular Department
John Hunter Hospital
Lookout Road
New Lambton NSW 2305
Country 70304 0
Australia
Phone 70304 0
+61249214202
Fax 70304 0
Email 70304 0
[email protected]

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
No additional documents have been identified.