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Trial registered on ANZCTR


Registration number
ACTRN12606000296538
Ethics application status
Approved
Date submitted
11/07/2006
Date registered
12/07/2006
Date last updated
12/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
To compare the effect of meals rich in thermally oxidised polyunsaturated fat and saturated fat on circulating numbers of endothelial microparticles
Scientific title
To compare the effect of meals rich in thermally oxidised polyunsaturated fat and saturated fat on circulating numbers of endothelial microparticles
Secondary ID [1] 287862 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects 1271 0
Condition category
Condition code
Other 1358 1358 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administer meals rich in (a) thermally oxidised polyunsaturated sunflower oil, (b) unoxidised native sunflower oil, (c) cream. The meals will be administered at the rate of one per week and they will be given in random order. The total duration of the study will be 3 weeks.
Intervention code [1] 1020 0
Other interventions
Comparator / control treatment
unoxidized native sunflower oil
Control group
Active

Outcomes
Primary outcome [1] 1851 0
Change in numbers of endothelial microparticles in the blood during 3 hour postprandial period.
Timepoint [1] 1851 0
The outcome will be measured at 1 h and at 3 h after the meals.
Secondary outcome [1] 3262 0
Changes in markers of oxidative stress including plasma peroxides and nitrotyrosine.
Timepoint [1] 3262 0
These variables will be measured at baseline and 1 h and 3 h after the meals.

Eligibility
Key inclusion criteria
Men and women aged 20-70 years
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious illnesses, smoke cigarettes, taking medications or antioxidant supplements.

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)
Allocation schedule held by independent person
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of each individual to one of 6 meal sequences using randomisation table from a statistics book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Comparison of three different meals
Phase
Type of endpoint(s)
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 306 0
New Zealand
State/province [1] 306 0

Funding & Sponsors
Funding source category [1] 1488 0
Charities/Societies/Foundations
Name [1] 1488 0
Otago Medical Research Foundation
Address [1] 1488 0
Otago Medical Research Foundation Inc
PO Box 1245
Dunedin
New Zealand
Country [1] 1488 0
New Zealand
Funding source category [2] 1489 0
Charities/Societies/Foundations
Name [2] 1489 0
Laurenson Award
Address [2] 1489 0
Otago Medical Research Foundation Inc
PO Box 1245
Dunedin
New Zealand
Country [2] 1489 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Otago Medical Research Foundation
Address
Otago Medical Research Foundation Inc
PO Box 1245
Dunedin
New Zealand
Country
New Zealand
Secondary sponsor category [1] 1310 0
University
Name [1] 1310 0
University of Otago
Address [1] 1310 0
University of Otago
PO Box 56
Dunedin
New Zealand
Country [1] 1310 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2912 0
Medicine Section Dunedin Hospital-Lower South Reginal Ethics Committee
Ethics committee address [1] 2912 0
9th Floor Dunedin Hospital Dunedin
Ethics committee country [1] 2912 0
New Zealand
Date submitted for ethics approval [1] 2912 0
Approval date [1] 2912 0
18/04/2006
Ethics approval number [1] 2912 0
LRS/06/02/003

Summary
Brief summary
Fatty fast food meals markedly and acutely increase circulating numbers of endothelial cell microparticles (EMPs) that are a marker of endothelial damage. These meals are usually rich in saturated fat and oxidized lipids that may adversely affect the vascular endothelium. Our study aims to compare the effect of ingesting heated polyunsaturated fats (PUFA) enriched in oxidized lipids, and unheated PUFA and saturated fat on circulating number of EMPs in healthy subjects. The findings of the study may indicate whether dietary advice that includes increased PUFA consumption and use in cooking needs to be modified.
Trial website
Trial related presentations / publications
Sutherland WHF, de Jong SA, Hessian PA, Williams MJA. ingestion of native and thermally oxidized polyunsaturated fats acutely increases circulating numbers of endothelial microparticles. Metabolism 2010; 59: 446-453.
Public notes

Contacts
Principal investigator
Name 35595 0
Dr Wayne HF Sutherland
Address 35595 0
Endocrinology Research Unit
Department of Medicine
University of Otago
PO Box 56
Dunedin
New Zealand
Country 35595 0
New Zealand
Phone 35595 0
+64 3 474 0999
Fax 35595 0
+64 3 4747641
Email 35595 0
wayne.sutherland@otago.ac.nz
Contact person for public queries
Name 10209 0
Dr Dr Wayne HF Sutherland
Address 10209 0
Endocrinology Research Unit
Department of Medicine
University of Otago
PO Box 56
Dunedin
New Zealand
Country 10209 0
New Zealand
Phone 10209 0
+64 3 474 0999
Fax 10209 0
+64 3 4747641
Email 10209 0
wayne.sutherland@otago.ac.nz
Contact person for scientific queries
Name 1137 0
Dr Dr Wayne HF Sutherland
Address 1137 0
Endocrinology Research Unit
Department of Medicine
University of Otago
PO Box 56
Dunedin
New Zealand
Country 1137 0
New Zealand
Phone 1137 0
+64 3 474 0999
Fax 1137 0
+64 3 4747641
Email 1137 0
wayne.sutherland@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary