Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000046909
Ethics application status
Approved
Date submitted
13/01/2011
Date registered
13/01/2011
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Microencapsulation for Enhanced Bioavailability of Fish Oil - Long Term Ingestion Study
Scientific title
Microencapsulation for Enhanced Bioavailability of Fish Oil in Healthy Adult Volunteers - Long Term Ingestion Study
Secondary ID [1] 253400 0
None
Universal Trial Number (UTN)
Trial acronym
BF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioavailabilty of microencapsulated omega-3 oil as a dietary supplement 258159 0
Condition category
Condition code
Diet and Nutrition 258338 258338 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the bioavailability of 3 delivery systems containing omega-3 oils (gel capsules versus two different MicroMAX powders – one formulated with milk protein-sugar and other milk protein-sugar-resistant starch) together with a flavoured milk in individuals. Bioavailability will be assessed by measurement of EPA & DHA in blood/plasma.

This is a non-blinded, parallel design study in which participants will be randomised to receive one of the three treatments to be consumed over a 4 week period immediately following a 4 week washout period.

Participants will be asked to abstain from consuming high omega-3 foods throughout the 8 weeks (includes 4 week washout and 4 week intervention).


The bioavailability of a daily dose of omega-3 oils delivered via the three above mentioned formats over 4 weeks is to be investigated. The two different MicroMAX powders (one formulated with milk protein-sugar and other milk protein-sugar-resistant starch) will each be provided in a daily dose of 8g containing 500mg/g omega-3 oil. The gel capsules will be given as a daily dose of 4 capsules (each capsule will contain 1000mg of omega-3 oil).
Intervention code [1] 257853 0
Treatment: Other
Comparator / control treatment
Being a bioavailabilty study the comparison to commonly available gel capsules will be considered the bench mark or comparator treatment to the 2 microencapsulated products. The subjects for this study have been recruited from existing database of past study volunteers.
Control group
Active

Outcomes
Primary outcome [1] 259191 0
As a parallel design, this study will focus on cumulative response of long term ingestion (28 days) as measured by incorporation into red blood cell membranes.

Red blood cell membrane fatty acids and lipids (cholesterol, TAG, HDL, LDL) will be measured at each appropriate time point.
Timepoint [1] 259191 0
A baseline measurement will be taken at the end of the 4 week washout period, and then at the end of weeks 2 and 4 of the 28 day treatment phase.
Secondary outcome [1] 265555 0
A selected panel of inflammatory markers (eg. CRP/TNF/VCAM etc.) and plasma total fatty acids.
Timepoint [1] 265555 0
As a parallel design this study will focus on cumulative response of long term ingestion (28 days) secondary outcomes listed above.

Baseline measurements will be taken at the end of the 4 week washout period, and then at the end of weeks 2 and 4 of the 28 day treatment phase.

Eligibility
Key inclusion criteria
(1) Male and Females aged between 18-70 years
(2) Normal dietary habits (no medically prescribed diet, no slimming diet, and no vegan or macrobiotic diet).
(3) Body Mass Index >18 kg/m^2 < 35kg/m^2 (calculation: Body Mass Index = weight in kg / height^2 in m^2).
(4) Apparently healthy: no reported current or previous metabolic diseases, gastrointestinal disorders, renal or cardiovascular disease.
(5) Person having given their specific consent in writing.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Regular use of supplements containing omega-3 essential fatty acids must have ceased 2 months prior to the start of the study.
(2) Current relevant medical treatment (subject to judgement of the investigator).
(3) High alcohol consumption (>21 standard drinks/week)
(4) Reported participation in another biomedical trial 3 months before the start of the study or during the study.
(5) Food allergies or intolerances (dairy, lactose, peanuts, shellfish, etc…).
(6) Recent history (within 12 months) of substance abuse including alcohol abuse.

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)
Subjects to be recruited from an existing database of past study volunteers based on inclusion and exclusion criteria set for this particular study. Random allocation to treatment groups will be done using the computer software programme Clinstat. At the time of recruitment, the person responsible for determining eligibilty will be unaware of which treatment group subjects will be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Volunteers will be randomised to a treatment using Clinstat randomisation programme.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257629 0
Other Collaborative groups
Name [1] 257629 0
CSIRO Preventative Health Flagship
Country [1] 257629 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CSIRO Preventative Health Flagship
Address
CSIRO Food and Nutritional Sciences, PO box 10041 Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256850 0
None
Name [1] 256850 0
Address [1] 256850 0
Country [1] 256850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259745 0
CSIRO Food and Nutritional Sciences Human Research Ethics Committee
Ethics committee address [1] 259745 0
Ethics committee country [1] 259745 0
Australia
Date submitted for ethics approval [1] 259745 0
Approval date [1] 259745 0
14/09/2010
Ethics approval number [1] 259745 0
10/20

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

Contacts
Principal investigator
Name 31628 0
Address 31628 0
Country 31628 0
Phone 31628 0
Fax 31628 0
Email 31628 0
Contact person for public queries
Name 14875 0
Peter Royle
Address 14875 0
C/- CSIRO Food and Nutritional Sciences
PO box 10041
Adelaide BC
South Australia 5000
Country 14875 0
Australia
Phone 14875 0
+61 8 8303 8947
Fax 14875 0
Email 14875 0
[email protected]
Contact person for scientific queries
Name 5803 0
Mahinda Abeywardena
Address 5803 0
C/- CSIRO Food and Nutritional Sciences
PO box 10041
Adelaide BC
South Australia 5000
Country 5803 0
Australia
Phone 5803 0
+61 8 8303 8800
Fax 5803 0
Email 5803 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.