Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000634875
Ethics application status
Approved
Date submitted
8/06/2012
Date registered
14/06/2012
Date last updated
22/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bioavailability of Omega-3 fatty acids after a novel microencapsulation process
Scientific title
Bioavailability of Omega-3 fatty acids in healthy male participants after a novel microencapsulation process
Secondary ID [1] 280668 0
None
Universal Trial Number (UTN)
U1111-1131-5972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioavailability of different formulations of Omega-3 oil 286662 0
Condition category
Condition code
Diet and Nutrition 286959 286959 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new technology for delivery of Omega-3 oils in foods. The amount of active ingredient (DHA/EPA fish oil) provided by the new technology (a seaweed gel encapsulant) will be 1300mg. It will be provided as a liquid oil emulsion in 300mL milk. This is a single dose delivered on one day only.

This is a crossover study with a 6-week washout period. The second treatment arm is 1300mg DHA/EPA fish oil without the
seaweed gel encapsulant. This is a single dose delivered on one day only.

The technology is planned to assist the delivery of higher concentrations of Omega-3 oils in food and beverage products, thereby facilitating the development of new functional food products.
Intervention code [1] 285047 0
Treatment: Other
Comparator / control treatment
1300mg DHA/EPA fish oil without seaweed gel encapsulant provided in 300mL milk. This is a single dose delivered on one day only.
Control group
Active

Outcomes
Primary outcome [1] 287300 0
Levels of DHA and EPA in plasma (mg/mL)
Timepoint [1] 287300 0
4 x baseline measures (3 days prior to and on the day of the trial starting). Intervention will be administered on the day of the trial. Measurements will be taken 2, 4, 6, 8, 24 hours after consumption of treatment one (1300mg EPA/DHA with the seaweed gel encapsulant) or treatment two (1300mg EPA/DHA without the seaweed gel encapsulant).
Secondary outcome [1] 297860 0
Tolerance questionnaire
Timepoint [1] 297860 0
day 5 of trial

Eligibility
Key inclusion criteria
(i) Age 18-60 years
(ii) Healthy body weight (body mass index [BMI] 18.5-24.9 kg/m2), not overweight or obese (to improve likelihood of compliance with diet imposed the week prior)
(iii) Not currently taking omega-3 supplements
(iv) Available to participate for an entire day at 2 time points, 6 weeks apart
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) BMI <18.5 or >24.9 kg/m2
(ii) Current infection
(iii) Current consumption of omega-3 supplements
(iv) Inability to provide informed consent due to diminished understanding or comprehension, or a language other than English spoken and an interpreter unavailable

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation to gel fish oil or non-gel fish oil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a randomisation computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2012
Actual
18/05/2012
Date of last participant enrolment
Anticipated
Actual
18/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285413 0
Commercial sector/Industry
Name [1] 285413 0
ProGel
Country [1] 285413 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Human Movement Studies
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 284264 0
University
Name [1] 284264 0
University of Queensland
Address [1] 284264 0
Food Sciences
St Lucia QLD 4072
Country [1] 284264 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287426 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 287426 0
University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 287426 0
Australia
Date submitted for ethics approval [1] 287426 0
Approval date [1] 287426 0
01/02/2012
Ethics approval number [1] 287426 0
2011001294

Summary
Brief summary
Long-chain Omega-3 fatty acids, Docosahexanoic Acid (DHA) and Eicosapentanoic Acid (EPA), are associated with reducing the risk of a range of chronic diseases, as well as inflammation. They are also linked to improved outcomes as adjunctive therapies in some cancers and arthritis, in addition to promoting growth and development. The National Health and Medical Research Council recommendation for males and females is outlined in Figure 1. Suggested Dietary Targets represent the amount recommended for the prevention of chronic disease, i.e. cardiovascular disease and is equivalent to the 90th percentile of intake of the Australian/New Zealand population. Unless people consume oily fish at least twice per week or take omega-3 fish oil capsules, meeting this recommendation is difficult. Fortifying foods with fish oil is a means of improving intakes of EPA/DHA, but existing encapsulation technologies prevent significant doses being incorporated into foods. Higher doses using the current technology produces unsatisfactory flavour profiles and instability in the product. This project aims to improve on this with a trialling a new technology.
Trial website
NIL
Trial related presentations / publications
Results report to industry.
Public notes

Contacts
Principal investigator
Name 34291 0
Dr Dr Olivia Wright
Address 34291 0
School of Human Movement and Nutrition Sciences
Connell Building
The University of Queensland
St Lucia QLD 4072
Country 34291 0
Australia
Phone 34291 0
+61 7 3365 6669
Fax 34291 0
Email 34291 0
[email protected]
Contact person for public queries
Name 17538 0
Mr Mr Cameron Turner
Address 17538 0
Progel
University of Queensland
St Lucia QLD 4072
Country 17538 0
Australia
Phone 17538 0
+61 7 3365 4073
Fax 17538 0
+61 7 3365 4433
Email 17538 0
[email protected]
Contact person for scientific queries
Name 8466 0
Dr Dr Olivia Wright
Address 8466 0
School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia QLD 4072
Country 8466 0
Australia
Phone 8466 0
+61 7 3365 6669
Fax 8466 0
+ 61 7 3365 6877
Email 8466 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
Dimensions AIBioavailability of a Novel Form of Microencapsulated Bovine Lactoferrin and Its Effect on Inflammatory Markers and the Gut Microbiome: A Pilot Study2018https://doi.org/10.3390/nu10081115
N.B. These documents automatically identified may not have been verified by the study sponsor.