Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000371796
Ethics application status
Approved
Date submitted
31/03/2013
Date registered
8/04/2013
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Trans fatty acid analysis in vegans
Scientific title
A cross sectional study assessing plasma trans fatty acid levels in New Zealand vegans
Secondary ID [1] 282220 0
nil
Universal Trial Number (UTN)
U1111-1141-2843
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma fats in healthy vegans 288737 0
Condition category
Condition code
Diet and Nutrition 289094 289094 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 sample of plasma for fatty acid analysis at one time point
Intervention code [1] 286834 0
Not applicable
Comparator / control treatment
participants in New Zealand Dairy from February 2011 to September 2011 - under review
studyACTRN12612000574842
Control group
Historical

Outcomes
Primary outcome [1] 289203 0
Plasma fatty acid levels
Timepoint [1] 289203 0
baseline
Secondary outcome [1] 302027 0
corelations between plasma TFA levels.
Timepoint [1] 302027 0
baseline

Eligibility
Key inclusion criteria
1. Aged over 18 years of age
2. Able to give informed consent
3. Are vegan
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Ingestion of any animal product in the last 12 weeks
2. On medications

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size
Based on the interventional study at Auckland city hospital, a total of 20 patients will enter this study. It is expected that no ruminant TFA will be detected in the sample.

Statistical analysis
Absolute levels of plasma phospholipids will be reported. Pearson’s’ correlation coefficient will be used to assess the relationship between fatty acids.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2013
Actual
5/08/2013
Date of last participant enrolment
Anticipated
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
2/09/2013
Sample size
Target
20
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 4966 0
New Zealand
State/province [1] 4966 0

Funding & Sponsors
Funding source category [1] 286981 0
University
Name [1] 286981 0
University of Auckland
Country [1] 286981 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
22 Princess Street, auckland,1030
Country
New Zealand
Secondary sponsor category [1] 285770 0
None
Name [1] 285770 0
Address [1] 285770 0
Country [1] 285770 0
Other collaborator category [1] 277342 0
Hospital
Name [1] 277342 0
Auckland City Hospital
Address [1] 277342 0
Park Rd, Grafton Auckland,1030
Country [1] 277342 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289031 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 289031 0
Novotel Ellerslie
72-112 Greenlane Rd East,
Auckland
1051
Ethics committee country [1] 289031 0
New Zealand
Date submitted for ethics approval [1] 289031 0
03/04/2013
Approval date [1] 289031 0
25/06/2013
Ethics approval number [1] 289031 0

Summary
Brief summary
Trans fats are found in dairy and in processed foods. The type of trans fats found in each food source is thought to be unique. We have recently completed a study in 180 healthy people who were asked to change dairy intake. Despite evidence that dairy intake was significantly changed; the trans fats from dairy did not. We then tested 7 brands of milk and found these Trans fats in milk samples.
The question remains, could these trans fats come from non-animal sources, or do humans have the capability of changing unsaturated fats into these trans fats (pretty unlikely). Testing trans fatty acid levels in vegans seems the best way to answer this question.
20 male or non-pregnant female age >18 years of age who are vegan will be asked to have 1 blood test. We will do a mass spectrometry test to look at all fatty acids. All trans fats will be measured and if present, we will see if they correlate with each other.
Trial website
Trial related presentations / publications
Cardiometabolic Risk Factors and Plasma Fatty Acids in Vegans – Results of an Observational Study
Benatar, J. et al.
Heart, Lung and Circulation , Volume 26 , S344
Public notes

Contacts
Principal investigator
Name 38878 0
Dr jocelyne benatar
Address 38878 0
Cardiovascular Research Unit
Cardiology Level 3
Auckland City Hospital
Park Rd
Auckland
1030
Country 38878 0
New Zealand
Phone 38878 0
+6421893886
Fax 38878 0
Email 38878 0
[email protected]
Contact person for public queries
Name 38879 0
jocelyne benatar
Address 38879 0
Cardiovascular Research Unit
Cardiology Level 3
Auckland City Hospital
Park Rd
Auckland
1030
Country 38879 0
New Zealand
Phone 38879 0
+6421893886
Fax 38879 0
Email 38879 0
[email protected]
Contact person for scientific queries
Name 38880 0
jocelyne benatar
Address 38880 0
Cardiovascular Research Unit
Cardiology Level 3
Auckland City Hospital
Park Rd
Auckland
1030
Country 38880 0
New Zealand
Phone 38880 0
+6421893886
Fax 38880 0
Email 38880 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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