Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000154202
Ethics application status
Approved
Date submitted
18/01/2018
Date registered
1/02/2018
Date last updated
1/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of 12-weeks supplementation with Superba™ Boost, a novel omega-3 supplement derived from krill oil, on omega-3 index and fatty acid biomarkers in healthy individuals
Scientific title
Effect of 12-weeks supplementation with Superba™ Boost, a novel omega-3 supplement derived from krill oil, on omega-3 index and fatty acid biomarkers in healthy individuals
Secondary ID [1] 293810 0
None
Universal Trial Number (UTN)
U1111-1208-0109
Trial acronym
None
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Nutritional deficiency 306224 0
Condition category
Condition code
Diet and Nutrition 305328 305328 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open label interventional trial for which fifty individuals consumed one capsule of Superba™ Boost, containing 1g krill oil (290mg omega-3 providing 160mg of EPA and 80mg of docosahexaenoic acid DHA) orally, each day over 12-weeks and attend study visits at baseline and 6 and 12-weeks. Compliance will be monitored by measurement of omega-3 index at baseline, week 6 and 12 as well as asking participants to keep a study diary documenting when the krill oil supplements are taken.
Intervention code [1] 300064 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304483 0
Effect of krill oil supplementation on Omega-3 index using the dry blood spot method.
Timepoint [1] 304483 0
Baseline, 6 and 12-weeks (primary endpoint)
Secondary outcome [1] 342109 0
Effect of krill oil supplementation on eicosapentaenoic acid (EPA) using the dry blood spot method.
Timepoint [1] 342109 0
Baseline, 6 and 12-weeks
Secondary outcome [2] 342110 0
Effect of krill oil supplementation on docosahexaenoic acid (DHA) using the dry blood spot method.
Timepoint [2] 342110 0
Baseline, 6 and 12-weeks
Secondary outcome [3] 342111 0
Effect of krill-oil supplementation on arachidonic acid (AA) using the dry blood spot method.
Timepoint [3] 342111 0
Baseline, 6 and 12-weeks
Secondary outcome [4] 342112 0
Effect of krill-oil supplementation on saturated fats using the dry blood spot method.
Timepoint [4] 342112 0
Baseline, 6 and 12-weeks
Secondary outcome [5] 342113 0
Effect of krill-oil supplementation on monounsaturated fats using the dry blood spot method.
Timepoint [5] 342113 0
Baseline, 6 and 12-weeks
Secondary outcome [6] 342114 0
Effect of krill-oil supplementation on trans-fats dry blood spot method.
Timepoint [6] 342114 0
Baseline, 6 and 12-weeks

Eligibility
Key inclusion criteria
Aged 18-75
Ability to provide informed consent
Baseline omega-3 index less than 8%
Not consumed fish oil supplements within three months
Not consumed more than four serves of fatty fish per month within the past three months
Not taking anticoagulant, antihypertensive or antihyperlipidaemic medications
Non-smoker
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Omega-3 index was in the high range (i.e. >8%)
Consumption of fish oil supplements or fatty fish more than four times a month within the past three months
Taking anticoagulant, antihypertensive or antihyperlipidaemic medications
Cigarette smokers

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
12-week intervention trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Means, standard deviations, minimums and maximums will be used to describe the baseline characteristics of the study sample. The primary analysis of change from baseline to week 12 will be conducted using the paired samples t-test. Results will be presented as means, standard deviations and associated p-values. Secondary analysis investigating changes from baseline to week 6 to week 12 will be conducted using repeated measures ANOVA with results presented as p-values and graphically as means plots with associated 95% confidence intervals. Age, gender and body mass index (BMI) will be investigated separately by inclusion in repeated measures ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/11/2016
Date of last participant enrolment
Anticipated
Actual
11/04/2017
Date of last data collection
Anticipated
Actual
5/07/2017
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 18594 0
2067 - Chatswood

Funding & Sponsors
Funding source category [1] 298426 0
Commercial sector/Industry
Name [1] 298426 0
FIT Bioceuticals Pty Ltd
Country [1] 298426 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
NICM, Western Sydney University
Locked Bag 1797
Penrith, NSW 2751, Australia
Country
Australia
Secondary sponsor category [1] 297567 0
None
Name [1] 297567 0
Address [1] 297567 0
Country [1] 297567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299422 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 299422 0
Ethics committee country [1] 299422 0
Australia
Date submitted for ethics approval [1] 299422 0
28/08/2016
Approval date [1] 299422 0
12/09/2016
Ethics approval number [1] 299422 0
H11787

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80350 0
Dr Kellie Bilinski
Address 80350 0
NICM, Western Sydney University
Locked Bag 1797
Penrith, NSW 2751, Australia
Country 80350 0
Australia
Phone 80350 0
61 430395129
Fax 80350 0
Email 80350 0
[email protected]
Contact person for public queries
Name 80351 0
Kellie Bilinski
Address 80351 0
NICM, Western Sydney University
Locked Bag 1797
Penrith, NSW 2751, Australia
Country 80351 0
Australia
Phone 80351 0
61 430395129
Fax 80351 0
Email 80351 0
[email protected]
Contact person for scientific queries
Name 80352 0
Kellie Bilinski
Address 80352 0
NICM, Western Sydney University
Locked Bag 1797
Penrith, NSW 2751, Australia
Country 80352 0
Australia
Phone 80352 0
61 430395129
Fax 80352 0
Email 80352 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
SourceTitleYear of PublicationDOI
EmbaseEffect of omega-3 supplementation on the omega-3 blood index and fatty acid biomarkers in healthy individuals.2020https://dx.doi.org/10.1016/j.aimed.2019.04.003
N.B. These documents automatically identified may not have been verified by the study sponsor.