Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000136707
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
5/02/2013
Date last updated
25/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute effects on vascular function of palm olein and olive oil in the context of a high protein test meal.
Scientific title
Acute effects on vascular function of palm olein and olive oil in the context of a high protein test meal in overweight men.
Secondary ID [1] 281892 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular function 288291 0
Overweight/obesity 288298 0
Condition category
Condition code
Diet and Nutrition 288635 288635 0 0
Obesity
Cardiovascular 288641 288641 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend the clinic at 2 times points for approximately 6 hour visit, with a 1 week wash out period between treatments. They will be asked to eat a meal, which will be comprised of ‘regular’ foods (chicken, bread and salad) plus 40g of either palmolein oil or control oil, offered in a randomised order. they will have 15 minutes to consume the meal. the meals will contain 30% energy from protein, 58% energy from fat and 11% energy from carbohydrate. total energy content of the test meals is ~2800kJ.
Intervention code [1] 286456 0
Lifestyle
Comparator / control treatment
An olive oil (40g) containing test meal is the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 288786 0
The aim of the study is to compare blood vessel elasticity after two protein-rich meals which are high in either olive oil or palmolein.

Diameter of the brachial artery of the right arm will be measured with participants laying supine using high-resolution external vascular ultrasound at baseline and during reactive hyperaemia (endothelium-dependent vasodilation).The diameter of the artery will be measured from two dimensional B-mode ultrasound (Accuson Aspen Duplex) images at the centre of the brachial artery, identified when the clearest picture of the anterior and posterior intimal layers is obtained. For the production of reactive hyperaemia, a sphygmomanometer cuff will be placed around the mid-point of the forearm and inflated to a pressure of 200 mmHg for 5-min. The arterial diameter will then be scanned every 30 sec for two min after the cuff is deflated, with the difference between the baseline scan diameter and the maximal diameter in response to the release of occlusion (expressed as a percentage of the baseline diameter) providing a measure of endothelium-dependent flow mediated dilatation.
Timepoint [1] 288786 0
baseline plus 1,2,3,4,5 hours post prandially
Secondary outcome [1] 300992 0
The study also aims to compare the effect of these test meals on a suite of blood markers of heart health (VCAM, ICAM, E-Selectin, plasminogen activator inhibitor-1 (total) nitrotyrosine, tissue plasminogen activator).
Timepoint [1] 300992 0
baseline plus 1,2,3,4,5 hours post prandially
Secondary outcome [2] 301009 0
triglycerides, assesed by blood serum assay
Timepoint [2] 301009 0
baseline, 1,2,3,4,5 hours postrandially
Secondary outcome [3] 301010 0
insulin, assesed by blood serum assay
Timepoint [3] 301010 0
baseline, 1,2,3,4,5 hours postrandially

Eligibility
Key inclusion criteria
Male
Age 18-65 years
BMI: 25-35 kg/m2 and weight stable over the previous 3 months.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Smoker (known to affect flow mediated dilatation - primary outcome)
History of heavy alcohol consumption (> 5 STD drinks/day)
Volunteer unable to limit alcohol consumption for study duration
Type 1 or Type 2 diabetes
Existing conditions that affect study outcomes, including kidney, respiratory, gastrointestinal, cardiovascular or peripheral vascular disease.
Use of nitrate medication, non-steroidal anti-inflammtory medication or medication or supplements that may affect gastrointestinal function (such as antibiotics, laxatives etc) during the 3 months prior to study – or which are known to affect the outcomes of interest.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/02/2013
Actual
9/10/2013
Date of last participant enrolment
Anticipated
Actual
28/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286675 0
Commercial sector/Industry
Name [1] 286675 0
Malaysian Palm Oil Board
Country [1] 286675 0
Malaysia
Primary sponsor type
Government body
Name
CSIRO Animal, Food and Health Sciences
Address
PO Box 10041
Adelaide BC SA 5000
Country
Australia
Secondary sponsor category [1] 285450 0
None
Name [1] 285450 0
Address [1] 285450 0
Country [1] 285450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288744 0
CSIRO Human Ethics Committee
Ethics committee address [1] 288744 0
Ethics committee country [1] 288744 0
Australia
Date submitted for ethics approval [1] 288744 0
Approval date [1] 288744 0
17/12/2012
Ethics approval number [1] 288744 0
1212

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

Contacts
Principal investigator
Name 37614 0
Prof Manny Noakes
Address 37614 0
Research Program Leader
CSIRO Animal, Food and Health Sciences
Gate 13 Kintore Ave
Adelaide
SA 5000
Country 37614 0
Australia
Phone 37614 0
+61 8 83038800
Fax 37614 0
Email 37614 0
[email protected]
Contact person for public queries
Name 37615 0
Welma Stonehouse
Address 37615 0
Research Scientist
CSIRO Animal, Food and Health Sciences
Gate 13 Kintore Ave
Adelaide
SA 5000
Country 37615 0
Australia
Phone 37615 0
+61 8 83038919
Fax 37615 0
Email 37615 0
[email protected]
Contact person for scientific queries
Name 37616 0
Welma Stonehouse
Address 37616 0
Research Scientist
CSIRO Animal, Food and Health Sciences
Gate 13 Kintore Ave
Adelaide
SA 5000
Country 37616 0
Australia
Phone 37616 0
+61 8 83038919
Fax 37616 0
Email 37616 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
SourceTitleYear of PublicationDOI
EmbasePalmolein and olive oil consumed within a high protein test meal have similar effects on postprandial endothelial function in overweight and obese men: A randomized controlled trial.2015https://dx.doi.org/10.1016/j.atherosclerosis.2015.01.009
N.B. These documents automatically identified may not have been verified by the study sponsor.