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Trial registered on ANZCTR


Registration number
ACTRN12609000425291
Ethics application status
Approved
Date submitted
26/05/2009
Date registered
10/06/2009
Date last updated
12/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acute effects of flavonoid-rich apples and nitrate-rich vegetables on nitric oxide status, blood pressure, endothelial function and cognitive function in healthy men and women
Scientific title
The acute effects of flavonoid-rich apples and nitrate-rich vegetables on nitric oxide status, blood pressure, endothelial function and cognitive function in healthy men and women
Secondary ID [1] 251982 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 4859 0
Cognitive function 236934 0
Condition category
Condition code
Cardiovascular 237206 237206 0 0
Coronary heart disease
Diet and Nutrition 237207 237207 0 0
Other diet and nutrition disorders
Cardiovascular 237208 237208 0 0
Hypertension

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 apples (rich in flavonoids) and green leafy vegetables such as spinach(rich in nitrate) on nitric oxide status, blood pressure, endothelial function and cognitive function.

Each participant will complete 4 visits (one treatment at each visit) one week apart in random order. The 4 treatments are:
1. Apple puree containing the apple skin (high flavonoid [~100 mg]) + spinach (high nitrate [~200 mg])
2. Apple puree containing the apple skin (high flavonoid [~100 mg]) + no spinach (low nitrate [0 mg])
3. Apple puree without the apple skin (low flavonoid [< 5 mg]) + spinach (high nitrate [~200 mg])
4. Apple puree without the apple skin (low flavonoid [< 5 mg]) + no spinach (low nitrate [0 mg])

Prior to each visit participants will be asked to consume a standard low flavonoid, low nitrate meal for breakfast. With each breakfast the participants will consume either: 1. Apple puree with apple skins (for treatments 1 and 2 above); or 2. Apple puree without apple skins (for treatments 3 and 4 above).

Participants will then attend the School of Medicine and Pharmacology Research Unit at Royal Perth Hospital where they will be provided with lunch consisting of a low flavonoid, low nitrate sandwich with one of the treatments. The total energy intake at each lunch will be the same: energy from the salad will be matched with rice milk (for treatments 2 and 4 only).
Intervention code [1] 236641 0
Treatment: Other
Comparator / control treatment
Low flavonoid and low nitrate meals
Control group
Dose comparison

Outcomes
Primary outcome [1] 238019 0
Nitric oxide status assessed by measuring plasma S-nitrosothiols
Timepoint [1] 238019 0
2.5 hours after lunch
Secondary outcome [1] 242161 0
Plasma, urinary and salivary nitrate and nitrite concentrations
Timepoint [1] 242161 0
Plasma measurements performed at 2.5 hours after lunch.
Urinary measurements performed in a single 8 hour urine collection. (This is a single 8 hour urine collection which begins just prior to the breakfast meal and is completed late afternoon. The collection is a pooled collection so that individual spot urine sampels will not be analysed separately.)

Salivary measurements performed at 1.5 hours after lunch.
Secondary outcome [2] 242162 0
Blood pressure measured using an automated blood pressure monitor
Timepoint [2] 242162 0
mean blood pressure measured every 20-30 min post lunch for 5 hours
Secondary outcome [3] 242163 0
Endothelial function assessed by measuring flow-mediated dilatation of the brachial artery using ultrasound; and by measuring peripheral arterial tone using the Endo-PAT 2000.
Timepoint [3] 242163 0
2 to 2.5 hours post lunch
Secondary outcome [4] 242164 0
Cognitive function assessed using the Cognitive Drug Research computerized measure of cognition
Timepoint [4] 242164 0
3 hours after lunch

Eligibility
Key inclusion criteria
Men and women aged 18 to 65 years
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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. A systolic blood pressure below 100 or above 160 mmHg
5. A diastolic blood pressure below 50 or above 100 mmHg
6. diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations greater than or equal to 5.5 mmol/L
7. A psychiatric illness
8. other major illnesses such as cancer
9. Current or recent (within previous 6 months) significant weight loss or gain (> 6% of body weight)
10. Reported lactating, pregnant or wishing to become pregnant during the study
11. Alcohol intake > 210 g per wk for women and > 280 g per wk for men
12. Inability or unwillingness to consume foods/beverages provided
13. Deformities of fingers
14. Unwillingness to have short nails on testing days
15. Unwillingness to stop the use of supplements with nitrates or bioflavonoids during the testing period
16. Not willing to give up the use of mouth wash from one week prior to the testing period to the end of the testing period

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. The envelopes will be used for randomisation by opening an envelope, in consecutive order, as participants are entered into the study. The envelopes will be held by an independent person within the University 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 the 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
Completed
Date of first participant enrolment
Anticipated
5/06/2009
Actual
5/06/2009
Date of last participant enrolment
Anticipated
21/03/2011
Actual
21/03/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5022 0
Government body
Name [1] 5022 0
NHMRC
Country [1] 5022 0
Australia
Funding source category [2] 5023 0
Government body
Name [2] 5023 0
ARC
Country [2] 5023 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 4542 0
None
Name [1] 4542 0
Address [1] 4542 0
Country [1] 4542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7121 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 7121 0
Ethics committee country [1] 7121 0
Australia
Date submitted for ethics approval [1] 7121 0
Approval date [1] 7121 0
11/02/2009
Ethics approval number [1] 7121 0
RA/4/1/2276

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

Contacts
Principal investigator
Name 29651 0
A/Prof Jonathan Hodgson
Address 29651 0
GPO Box X2213, Perth, WA 6847
Country 29651 0
Australia
Phone 29651 0
+61 8 9224 0267
Fax 29651 0
Email 29651 0
[email protected]
Contact person for public queries
Name 12898 0
Jonathan Hodgson
Address 12898 0
GPO Box X2213, Perth, WA 6847
Country 12898 0
Australia
Phone 12898 0
+61 8 9224 0267
Fax 12898 0
+61 8 9224 0246
Email 12898 0
[email protected]
Contact person for scientific queries
Name 3826 0
Catherine Bondonno
Address 3826 0
GPO Box X2213, Perth, WA 6847
Country 3826 0
Australia
Phone 3826 0
+61 8 9224 0342
Fax 3826 0
+61 8 9224 0246
Email 3826 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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