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Trial registered on ANZCTR


Registration number
ACTRN12615000472572
Ethics application status
Approved
Date submitted
1/05/2015
Date registered
14/05/2015
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of 30 day krill oil supplementation on cardiovascular risk factors
Scientific title
Investigation of krill oil and cardio-metabolic risk factors in healthy women
Secondary ID [1] 286461 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risks 294648 0
Metabolic and Endocrine 295011 0
Condition category
Condition code
Cardiovascular 294944 294944 0 0
Coronary heart disease
Metabolic and Endocrine 295275 295275 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ingestion of krill oil capsules daily containing 1.7g of total EPA + DPA + DHA daily for 30 days followed by 30 days washout period. The break-down concentration for individual fatty acids are: 1086mg EPA, 611mg DHA and 32mg of DPA. Adherence to intervention protocols will be monitored at day 0, 5, 10, 15 and 30 through clinical visits - capsule calendar will be collected at each visit.
Intervention code [1] 291545 0
Prevention
Comparator / control treatment
Ingestion of fish oil capsules daily containing 1.7g of total EPA + DPA + DHA for 30 days. The break-down concentration for individual fatty acids are: 995mg EPA, 650mg DHA and 102mg of DPA. Adherence to intervention protocols will be monitored at day 0, 5, 10, 15 and 30 through clinical visits - capsule calendar will be collected at each visit.
Control group
Active

Outcomes
Primary outcome [1] 294700 0
Changes in blood fatty acid composition. This will be analysed using Gas Chromatography
Timepoint [1] 294700 0
At days 5, 10, 15 and 30 post intervention for each dietary oil supplement
Primary outcome [2] 295019 0
Changes in lipid profiles. This will be analysed using immunoassay testing kits.
Timepoint [2] 295019 0
At days 5, 10, 15 and 30 post intervention for each dietary oil supplement
Secondary outcome [1] 313891 0
Alteration in insulin will be assessed using plasma sample with enzyme immunoassay testing kits.
Timepoint [1] 313891 0
30 days post intervention for each each dietary oil supplement
Secondary outcome [2] 314450 0
Changes in thrombotic bio-markers. These will be measured using plasma sample with enzyme immunoassay testing kits.
Timepoint [2] 314450 0
30 days post intervention for each each dietary oil supplement
Secondary outcome [3] 314586 0
Inflammatory bio-markers will be analysed using plasma sample with enzyme immunoassay testing kits.
Timepoint [3] 314586 0
30 days posti ntervention for each each dietary oil supplement
Secondary outcome [4] 314587 0
Oxidative stress bio-markers will be analysed using plasma sample with enzyme immunoassay testing kits.
Timepoint [4] 314587 0
30 days posti ntervention for each each dietary oil supplement

Eligibility
Key inclusion criteria
Females have not experienced menopause, body mass index (BMI) between 20 and 30 (kg/m2).
Minimum age
18 Years
Maximum age
50 Years
Gender
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, anti-hypertension, 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)
Cross-over study with fish oil and krill oil supplementation. Subjects will be randomized using computer software.
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
Cross-over study
Phase
Phase 3
Type of endpoint(s)
Efficacy
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 and t-test using SPSS and/or Excel software will be performed to analyse the data.

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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3738 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 9618 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 291029 0
University
Name [1] 291029 0
Victoria University
Address [1] 291029 0
College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001
Country [1] 291029 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
College of Health and Biomedicine
Victoria University
McKechnie Street
St Albans
PO Box 14428
Melbourne 8001
VIC 8001
Country
Australia
Secondary sponsor category [1] 289867 0
University
Name [1] 289867 0
Deakin University
Address [1] 289867 0
School of Medicine
Deakin University
75 Pigdons Road
Waurn Ponds
Geelong
Victoria 3216
Country [1] 289867 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292613 0
Victoria University Ethics Committee
Ethics committee address [1] 292613 0
Victoria University
Office for Research
Footscray Park Campus
Ballarat Road, Footscray
Victoria 3011
Ethics committee country [1] 292613 0
Australia
Date submitted for ethics approval [1] 292613 0
Approval date [1] 292613 0
23/04/2015
Ethics approval number [1] 292613 0
HRE 15-031

Summary
Brief summary
The health benefits of long-chain n-3 polyunsaturated fatty acids 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, inhibit inflammatory response, suppress thrombosis process. Krill oil and fish oil are rich sources of EPA and DHA. The bio-availability of these fatty acids from the two oils maybe different due to chemical structure of the oils. This study will evaluate the incorporation of EPA and DHA into the red blood cell membrane. 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 55562 0
Dr Xiao Su
Address 55562 0
College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001
Country 55562 0
Australia
Phone 55562 0
+ 61 3 99192318
Fax 55562 0
+61 3 99192465
Email 55562 0
xiao.su@vu.edu.au
Contact person for public queries
Name 55563 0
Miss Hyunsin (Hedy) Sung
Address 55563 0
College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001
Country 55563 0
Australia
Phone 55563 0
+61 3 99192711
Fax 55563 0
+61 401573352
Email 55563 0
hyunsin.sung@live.vu.edu.au
Contact person for scientific queries
Name 55564 0
Dr Xiao Su
Address 55564 0
College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001
Country 55564 0
Australia
Phone 55564 0
+ 61 3 99192318
Fax 55564 0
+61 3 99192465
Email 55564 0
xiao.su@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary