Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000620527
Ethics application status
Approved
Date submitted
20/05/2015
Date registered
15/06/2015
Date last updated
15/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postprandial effect of krill oil supplementation in healthy female subjects
Scientific title
Investigation of the postprandial effect of krill oil supplementation on fatty acid metabolism and cardio-metabolic risk factors in healthy females
Secondary ID [1] 286765 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
 295141 0
Metabolic and Endocrine disorders 295207 0
Condition category
Condition code
Cardiovascular 295383 295383 0 0
Coronary heart disease
Metabolic and Endocrine 295384 295384 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ingestion of 5 x 1g krill oil capsules (containing 833 mg EPA + 471 mg DHA) with breakfast once (in the teaching clinic) followed by 1 week washout period, and
Ingestion of 5 x 1g of fish oil capsules (containing 1037mg EPA + 745 mg DHA) with breakfast once (in the teaching clinic) followed by 1 week washout period.
Standardised breakfast (150g mashed potatoes with 600mL water) is provided. The breakfast is mixed with the intervention oil by the researcher before serving to the participants. Therefore adherence ensured.
Intervention code [1] 291919 0
Prevention
Comparator / control treatment
Ingestion of 5 x 1g of olive oil capsules with breakfast once only.
Control group
Placebo

Outcomes
Primary outcome [1] 295118 0
Changes in plasma fatty acid composition. This will be analysed using Gas Chromatography
Timepoint [1] 295118 0
At hours 1-5 post intervention for each dietary oil supplement
Secondary outcome [1] 314806 0
Changes in blood lipid profiles including triglycerides, cholesterol, HDL-C and LDL-C will be assessed using plasma sample with enzyme
immunoassay testing kits.
Timepoint [1] 314806 0
At hours 1-5 post intervention for each dietary oil supplement.
Secondary outcome [2] 314807 0
Inflammatory bio-markers including CRP, IL-1 and IL-6 will be analysed using plasma sample with
enzyme immunoassay testing kits.
Timepoint [2] 314807 0
5 hours post intervention

Eligibility
Key inclusion criteria
Healthy females aged 18-45 years and have not experienced menopause, body mass index (BMI) between 20 and 30 (kg/m2).
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cigarette smoker; all types of heart, liver or kidney disease, diabetes; pregnancy; lactating; medications of cholesterol lowering, antihypertension, anti-inflammation, anti-coagulation or anti-depression; omega-3 or antioxidant supplements in the past four weeks prior to the study.

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)
Allocation is not concealed.
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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Bio-availability
Statistical methods / analysis
The sample size was determined by statistical power analyses (two tailed t-test at the 5% significance level for the power of 90%) of expected differences (50%) in the major measured variables (EPA & DHA concentration in plasma).

ANOVA using SPSS and/or Excel software will be performed to analyse the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2014
Actual
15/07/2014
Date of last participant enrolment
Anticipated
4/11/2014
Actual
4/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291308 0
University
Name [1] 291308 0
Victoria University
Country [1] 291308 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
College of Health and Biomedicine
Victoria University
St Albans Campus
PO Box 14428
Melbourne, VIC 8001
Country
Australia
Secondary sponsor category [1] 289988 0
University
Name [1] 289988 0
Deakin University
Address [1] 289988 0
School of Medicine
Deakin University
75 Pigdons Road
Waurn Ponds
Geelong
Victoria 3216
Country [1] 289988 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292874 0
Victoria University Ethics Committee
Ethics committee address [1] 292874 0
Victoria University
Office for Research
Footscray Park Campus
Ballarat Road, Footscray
Victoria 3011
Ethics committee country [1] 292874 0
Australia
Date submitted for ethics approval [1] 292874 0
Approval date [1] 292874 0
19/06/2014
Ethics approval number [1] 292874 0
HRE14-040

Summary
Brief summary
The health benefits of long-chain n-3 polyunsaturated fatty acids from krill oil and fish oil are associated with the incorporation of EPA and DHA into the cell membrane
which then alters the membrane structure and cell functions. Consequently they reduce plasma triglyceride level and inhibit inflammatory response. The bio-availability of these fatty acids from the two oils maybe different due to the binding of fatty acids in the oils. This study will evaluate the
incorporation of EPA and DHA into the plasma and chylomicron after a single dose supplementation. In addition
the effects on cardio-metabolic risk factors will also be investigated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57462 0
Dr Xiao Su
Address 57462 0
College of Health and Biomedicine
Victoria University
St Albans Campus
PO Box 14428
Melbourne VIC 8001
Country 57462 0
Australia
Phone 57462 0
+ 61 3 99192318
Fax 57462 0
Email 57462 0
xiao.su@vu.edu.au
Contact person for public queries
Name 57463 0
Xiao Su
Address 57463 0
College of Health and Biomedicine
Victoria University
St Albans Campus
PO Box 14428
Melbourne VIC 8001
Country 57463 0
Australia
Phone 57463 0
+ 61 3 99192318
Fax 57463 0
Email 57463 0
xiao.su@vu.edu.au
Contact person for scientific queries
Name 57464 0
Xiao Su
Address 57464 0
College of Health and Biomedicine
Victoria University
St Albans Campus
PO Box 14428
Melbourne VIC 8001
Country 57464 0
New Zealand
Phone 57464 0
+ 61 3 99192318
Fax 57464 0
Email 57464 0
xiao.su@vu.edu.au

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
EmbaseDifferential plasma postprandial lipidomic responses to krill oil and fish oil supplementations in women: A randomized crossover study.2019https://dx.doi.org/10.1016/j.nut.2019.03.021
N.B. These documents automatically identified may not have been verified by the study sponsor.