Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000656932
Ethics application status
Approved
Date submitted
9/06/2011
Date registered
27/06/2011
Date last updated
5/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Do health benefits of vegetable derived compounds on healthy blood flow depend on the structure they were consumed in?
Scientific title
Effect of food structure on the bioavailability and the bioactivity of vegetable derived compounds on the healthy blood flow of healthy adults -a crossover study.
Secondary ID [1] 262346 0
Nil
Universal Trial Number (UTN)
U1111-1122-0705
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy blood flow 268047 0
Condition category
Condition code
Cardiovascular 268184 268184 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Platelet aggregation before and after consuming vegatables in various food structures. there will be two treatments (liquid form of vegetable (approximately 250mL) and solid form (approximately 100g)of vegetable). Meal (breakfast) consumed once only over a period of approximately 20 minutes. The wash-out period will be 48 hours.
Intervention code [1] 266736 0
Treatment: Other
Intervention code [2] 266838 0
Lifestyle
Intervention code [3] 266839 0
Prevention
Comparator / control treatment
No there is no third arm in this trial
Control group
Active

Outcomes
Primary outcome [1] 266929 0
Effect of food structure on platelet aggregation and thereby to maintain healthy blood flow. Platelet aggreagtion will be measured by an aggregometer.
Timepoint [1] 266929 0
Baseline, 2, 5, 8 and 24 hours after intervention commencement.
Secondary outcome [1] 276640 0
To see the effect of food structure on the bioavailability of vegetable derived compounds by measuring the levels of the selected compounds in plasma and urine samples.
Timepoint [1] 276640 0
Baseline, 2,5,8 and 24 hours after intervention commencement.

Eligibility
Key inclusion criteria
Healthy adult males
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers
On regular medications

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/07/2011
Actual
3/10/2011
Date of last participant enrolment
Anticipated
4/11/2011
Actual
4/11/2011
Date of last data collection
Anticipated
Actual
20/02/2012
Sample size
Target
25
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 3622 0
New Zealand
State/province [1] 3622 0
Palmerston North

Funding & Sponsors
Funding source category [1] 267225 0
Government body
Name [1] 267225 0
New Zealand Institute of Plant and Food Research
Country [1] 267225 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute of Plant and Food Research
Address
Private Bag 11600
Palmerston North
4442
New Zealand
Country
New Zealand
Secondary sponsor category [1] 266291 0
None
Name [1] 266291 0
Address [1] 266291 0
Country [1] 266291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269217 0
Upper south A regional ethics committee
Ethics committee address [1] 269217 0
Ethics committee country [1] 269217 0
New Zealand
Date submitted for ethics approval [1] 269217 0
01/08/2011
Approval date [1] 269217 0
28/09/2011
Ethics approval number [1] 269217 0
URA/11/08/047

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

Contacts
Principal investigator
Name 32720 0
Dr Juliet Ansell
Address 32720 0
Plant and Food Research Private Bag 11600 Palmerston North 4442 New Zealand
Country 32720 0
New Zealand
Phone 32720 0
+64 6 3556108
Fax 32720 0
+64 6 3517050
Email 32720 0
[email protected]
Contact person for public queries
Name 15967 0
Thanuja Herath
Address 15967 0
Plant and Food Research
Private Bag 11600
Palmerston North
4442
New Zealand
Country 15967 0
New Zealand
Phone 15967 0
+64 6 3556122
Fax 15967 0
+64 6 3517050
Email 15967 0
[email protected]
Contact person for scientific queries
Name 6895 0
Dr. Juliet Ansell
Address 6895 0
Plant and Food Research
Private Bag 11600
Palmerston North
4442
New Zealand
Country 6895 0
New Zealand
Phone 6895 0
+64 6 3556108
Fax 6895 0
+64 6 3517050
Email 6895 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.