ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

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]

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]

Levels of DHA and EPA in plasma (mg/mL)

Timepoint [1]

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]

Tolerance questionnaire

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

ProGel

Address [1]

University of Queensland
St Lucia QLD 4072

Country [1]

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]

University

Name [1]

University of Queensland

Address [1]

Food Sciences
St Lucia QLD 4072

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Queensland Medical Research Ethics Committee

Ethics committee address [1]

University of Queensland
St Lucia QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/02/2012

Ethics approval number [1]

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

Dr Dr Olivia Wright

Address

School of Human Movement and Nutrition Sciences
Connell Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 7 3365 6669

Fax

[email protected]

Contact person for public queries

Name

Mr Cameron Turner

Address

Progel
University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 7 3365 4073

Fax

+61 7 3365 4433

[email protected]

Contact person for scientific queries

Name

Dr Olivia Wright

Address

School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia QLD 4072

Country

Australia

Phone

+61 7 3365 6669

Fax

+ 61 7 3365 6877

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Bioavailability of a Novel Form of Microencapsulated Bovine Lactoferrin and Its Effect on Inflammatory Markers and the Gut Microbiome: A Pilot Study	2018	https://doi.org/10.3390/nu10081115

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

Trial Review

Documents added manually

Documents added automatically