Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000243516
Ethics application status
Approved
Date submitted
7/06/2006
Date registered
15/06/2006
Date last updated
15/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of novel fatty acid oxidation products in heart disease
Scientific title
To determine whether flaxseed oil supplementation in healthy men produces novel fatty acid oxidation products in plasma and urine.
Universal Trial Number (UTN)
Trial acronym
Floxi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy men 1220 0
Condition category
Condition code
Diet and Nutrition 1304 1304 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is placebo-controlled, double-blind, of parallel design. Participants will be randomly allocated to take capsules of 9 X 1gm per day of flaxseed oil (By Nature, Perth, Western Australia), orally for 4 weeks, while maintaining their normal dietary habits and physically activity.
Intervention code [1] 1131 0
Other interventions
Comparator / control treatment
Participants will be randomly allocated to take capsules of 9 X 1gm per day of olive oil (Cardinal Health Australia, Braeside, Victoria), orally for 4 weeks, while maintaining their normal dietary habits and physically activity.
Control group
Placebo

Outcomes
Primary outcome [1] 1784 0
This project will examine whether fatty acids that occur naturally in the diet, when consumed as flaxseed oil, are converted in the body to novel fatty acid oxidation products known as phytoprostanes
Timepoint [1] 1784 0
After 4 weeks supplementation with flaxseed oil.
Secondary outcome [1] 3138 0
Total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.
Timepoint [1] 3138 0
After 4weeks supplementation.

Eligibility
Key inclusion criteria
Healthy, non-smoking, non-diabetic, not taking medication or dietary supplements.
Minimum age
20 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Angina pectoris; major surgery or a cardiovascular event or diagnosis <12 months; liver or kidney disease; current smokers; fasting blood triglycerides >1.8 mmol/L; 2 or less fish meals per week or regularly taking fish oil capsules.

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)
Central allocation by a statistician not involved with the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computor generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1431 0
Charities/Societies/Foundations
Name [1] 1431 0
National Heart Foundation of Australia
Country [1] 1431 0
Australia
Primary sponsor type
Individual
Name
Dr Trevor Mori
Address
School of Medicine & Pharmacology
GPO Box X2213
Perth WA 6847
Country
Australia
Secondary sponsor category [1] 1261 0
Individual
Name [1] 1261 0
Dr Anne Barden
Address [1] 1261 0
School of Medicine & Pharmacology
GPO Box X2213
Perth WA 6847
Country [1] 1261 0
Australia
Secondary sponsor category [2] 1262 0
Individual
Name [2] 1262 0
Professor Kevin Croft
Address [2] 1262 0
School of Medicine & Pharmacology
GPO Box X2213
Perth WA 6847
Country [2] 1262 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2805 0
University of Western Australia
Ethics committee address [1] 2805 0
Ethics committee country [1] 2805 0
Date submitted for ethics approval [1] 2805 0
Approval date [1] 2805 0
13/03/2006
Ethics approval number [1] 2805 0
RA/4/1/1442

Summary
Brief summary
The hypothesis is that fatty acids consumed in flaxseed oil are converted in the body to novel fatty acid oxidation products. The purpose of the study is to determine whether these fatty acid oxidation products can be measured in the blood and urine of men following supplementation with flaxseed oil for 4 weeks. The study subjects, the investigators and the statistical analyst are blinded to the treatment allocation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35396 0
Address 35396 0
Country 35396 0
Phone 35396 0
Fax 35396 0
Email 35396 0
Contact person for public queries
Name 10320 0
Dr Trevor Mori
Address 10320 0
GPO Box X2213
Perth WA 6847
Country 10320 0
Australia
Phone 10320 0
+61 8 92240273
Fax 10320 0
+61 8 92240246
Email 10320 0
[email protected]
Contact person for scientific queries
Name 1248 0
Dr Trevor Mori
Address 1248 0
GPO Box X2213
Perth WA 6847
Country 1248 0
Australia
Phone 1248 0
+61 8 92240273
Fax 1248 0
+61 8 92240246
Email 1248 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.