Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000364279
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
26/05/2009
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effects of dietary flavonoids and nitrate on blood pressure, endothelial function and nitric oxide (NO) status in healthy men and women
Scientific title
The acute effects of dietary flavonoids and nitrate on blood pressure, endothelial function and nitric oxide (NO) status in healthy men and women
Secondary ID [1] 296610 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 4319 0
Condition category
Condition code
Cardiovascular 4553 4553 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, controlled, cross-over (latin square) designed trial will be performed to investigate the acute effects of quercetin and nitrate on blood pressure, endothelial function and NO status. Each participant will complete 4 visits one week apart in random order. Prior to each visit participants will be asked to consume a standard low flavonoid, low nitrate meal for breakfast. For each visit participants will attend the School of Medicine and Pharmacology Research Unit at Royal Perth Hospital in the morning prior to lunch. The treatments will correspond to:
1. 200 mg quercetin + 200 mg nitrate as sodium nitrate (270 mg)
2. 200 mg quercetin + nitrate control (180 mg of sodium chloride)
3. quercetin control (no quercetin) + 200 mg nitrate as sodium nitrate (270 mg)
4. quercetin control (no quercetin) + nitrate control (180 mg of sodium chloride)
Each of these treatments will be consumed dissolved in 200 ml of warm water and consumed over less than 1 min, immediately after a fixed energy lunch.
Intervention code [1] 4049 0
Treatment: Other
Comparator / control treatment
Placebo
no quercetin
sodium nitrate
Control group
Placebo

Outcomes
Primary outcome [1] 5433 0
Mean blood pressure between 2 and 6 hours after treatment measured using an automated blood pressure monitor
Timepoint [1] 5433 0
Blood pressure will be measured at baseline then every 20 minutes between 2 and 6 hours
Secondary outcome [1] 9128 0
Change in blood pressure over time (slope)
Timepoint [1] 9128 0
Between 1 and 3.5 hours after treatment with blood pressure measurements taken every 20 minutes
Secondary outcome [2] 9129 0
Endothelial function assessed by measuring flow mediated dilatation of the brachial artery
Timepoint [2] 9129 0
Baseline and 2.5 hours after treatment
Secondary outcome [3] 9130 0
Measures of nitric oxide status, including plasma s-nitrosothiols and nitrite and urinary nitrate concentrations
Timepoint [3] 9130 0
Baseline, and 2 hours and 4 hours after treatment

Eligibility
Key inclusion criteria
Healthy non smoking men and women
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will include:
1. current or recent (<12 months) smoking
2. body mass index < 18 or > 35 kg/m2,
3. history of cardiovascular or peripheral vascular disease,
4. diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 5.5 mmol/L,
5. a psychiatric illness,
6. other major illnesses such as cancer,
7. current or recent (within previous 6 months) significant weight loss or gain (> 6% of body weight),
8. reported lactating, pregnant or wishing to become pregnant during the study,
9. alcohol intake > 210 g per wk for women and > 280 g per wk for men, and
10. inability or unwillingness to consume foods/beverages provided.

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)
The treatment order for eligible individuals will be randomly assigned using computer generated random numbers. The treatment order allocation will be sealed in numbered envelopes. These envelopes will be used for randomisation by opening an envelope, in consecutive order, as participants are entered into the study. These envelopes will be held by an independent person within the Univesity of Western Australia. The study coordinator will contact the independent person to obtain the next available envelope once an individual is deemed eligible. The envelope will be opened and code will be recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers using Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4491 0
Government body
Name [1] 4491 0
National Health & Medical Research Council
Country [1] 4491 0
Australia
Funding source category [2] 4492 0
Government body
Name [2] 4492 0
Australian Research Council
Country [2] 4492 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth
Country
Australia
Secondary sponsor category [1] 4055 0
None
Name [1] 4055 0
Address [1] 4055 0
Country [1] 4055 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6552 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 6552 0
The University of Western Australia
35 Stirling Highway
Crawley WA 6009
Perth
Ethics committee country [1] 6552 0
Australia
Date submitted for ethics approval [1] 6552 0
Approval date [1] 6552 0
11/02/2009
Ethics approval number [1] 6552 0
R09/3841

Summary
Brief summary
The primary objective of this study is to investigate the acute effects of dietary flavonoids (quercetin) and nitrate on blood pressure, endothelial function and nitric oxide (NO) status in men and women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29279 0
Address 29279 0
Country 29279 0
Phone 29279 0
Fax 29279 0
Email 29279 0
Contact person for public queries
Name 12526 0
Jonathan Hodgson
Address 12526 0
GPO Box X2213
Perth, WA 6847
Country 12526 0
Australia
Phone 12526 0
+61 8 9224 0267
Fax 12526 0
+61 8 9224 0246
Email 12526 0
[email protected]
Contact person for scientific queries
Name 3454 0
Jonathan Hodgson
Address 3454 0
GPO Box X2213
Perth, WA 6847
Country 3454 0
Australia
Phone 3454 0
+61 8 9224 0267
Fax 3454 0
+61 8 9224 0246
Email 3454 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.