ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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

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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiovascular risks

Metabolic and Endocrine

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

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]

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]

Changes in blood fatty acid composition. This will be analysed using Gas Chromatography

Timepoint [1]

At days 5, 10, 15 and 30 post intervention for each dietary oil supplement

Primary outcome [2]

Changes in lipid profiles. This will be analysed using immunoassay testing kits.

Timepoint [2]

At days 5, 10, 15 and 30 post intervention for each dietary oil supplement

Secondary outcome [1]

Alteration in insulin will be assessed using plasma sample with enzyme immunoassay testing kits.

Timepoint [1]

30 days post intervention for each each dietary oil supplement

Secondary outcome [2]

Changes in thrombotic bio-markers. These will be measured using plasma sample with enzyme immunoassay testing kits.

Timepoint [2]

30 days post intervention for each each dietary oil supplement

Secondary outcome [3]

Inflammatory bio-markers will be analysed using plasma sample with enzyme immunoassay testing kits.

Timepoint [3]

30 days posti ntervention for each each dietary oil supplement

Secondary outcome [4]

Oxidative stress bio-markers will be analysed using plasma sample with enzyme immunoassay testing kits.

Timepoint [4]

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

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, 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

18/05/2015

Actual

12/05/2015

Date of last participant enrolment

Anticipated

30/01/2016

Actual

24/08/2015

Date of last data collection

Anticipated

Actual

13/12/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Sunshine Hospital - St Albans

Recruitment postcode(s) [1]

3021 - St Albans

Funding & Sponsors

Funding source category [1]

University

Name [1]

Victoria University

Address [1]

College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001

Country [1]

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]

University

Name [1]

Deakin University

Address [1]

School of Medicine
Deakin University
75 Pigdons Road
Waurn Ponds
Geelong
Victoria 3216

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Victoria University Ethics Committee

Ethics committee address [1]

Victoria University 
Office for Research 
Footscray Park Campus
Ballarat Road, Footscray
Victoria 3011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/04/2015

Ethics approval number [1]

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

Dr Xiao Su

Address

College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001

Country

Australia

Phone

+ 61 3 99192318

Fax

+61 3 99192465

xiao.su@vu.edu.au

Contact person for public queries

Name

Hyunsin (Hedy) Sung

Address

College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001

Country

Australia

Phone

+61 3 99192711

Fax

+61 401573352

hyunsin.sung@live.vu.edu.au

Contact person for scientific queries

Name

Xiao Su

Address

College of Health and Biomedicine
Victoria University, St Albans Campus
PO Box 14428
Melbourne, VIC 8001

Country

Australia

Phone

+ 61 3 99192318

Fax

+61 3 99192465

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?

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

Source	Title	Year of Publication	DOI
Embase	Krill oil has different effects on the plasma lipidome compared with fish oil following 30 days of supplementation in healthy women: A randomized controlled and crossover study.	2020	https://dx.doi.org/10.3390/nu12092804

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically