Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000602921
Ethics application status
Not yet submitted
Date submitted
10/06/2011
Date registered
10/06/2011
Date last updated
10/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Glycaemic effects of Omega-3 (GEO) - Can omega-3 (fish oil) supplementation improve insulin sensitivity in middle aged males?
Scientific title
Can dietary supplementation with n-3 long chain polyunsaturated fatty acids compared with placebo improve insulin sensitivity in overweight middle aged males?
Secondary ID [1] 262353 0
Nil
Universal Trial Number (UTN)
U1111-1122-0964
Trial acronym
GEO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin resistance 268055 0
Overweight 268057 0
Condition category
Condition code
Metabolic and Endocrine 268197 268197 0 0
Diabetes
Diet and Nutrition 268200 268200 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
n-3 long chain polyunsaturated fatty acids from marine source at a dose of 1.4g/day for 8 weeks given in the form of oral capsules. There will be a 4 week washout period between swapping treatments.
Intervention code [1] 266745 0
Treatment: Other
Intervention code [2] 266747 0
Prevention
Comparator / control treatment
Placebo oil capsule containing a vegetable oil without n-3 LC PUFAs, likely safflower oil, given for 8 weeks in the form of oral capsules. There will be a 4 week washout period before swapping treatments.
Control group
Placebo

Outcomes
Primary outcome [1] 266936 0
Insulin resistance as measured by Matsuda index from oral glucose tolerance test
Timepoint [1] 266936 0
After 8 weeks of taking the n-3 PUFA oil or placebo oil
Secondary outcome [1] 276656 0
Physiological assessments
body mass index, body composition by DEXA scan
Timepoint [1] 276656 0
After 8 weeks of taking the n-3 PUFA oil or placebo oil
Secondary outcome [2] 276657 0
Serum lipids
Timepoint [2] 276657 0
After 8 weeks of taking the n-3 PUFA oil or placebo oil
Secondary outcome [3] 276658 0
Carotid Artery intimal thickness, measured using ultrasound scan.
Timepoint [3] 276658 0
After 8 weeks of taking the n-3 PUFA oil or placebo oil
Secondary outcome [4] 276659 0
Serum inflammatory markers
Timepoint [4] 276659 0
After 8 weeks of taking the n-3 PUFA oil or placebo oil
Secondary outcome [5] 276660 0
General Wellness by SF-36 Quality of Life Questionnaire
Timepoint [5] 276660 0
After 8 weeks of taking the n-3 PUFA oil or placebo oil
Secondary outcome [6] 276661 0
Serum adipokine levels - adiponectin and leptin
Timepoint [6] 276661 0
After 8 weeks of taking the n-3 PUFA oil or placebo oil

Eligibility
Key inclusion criteria
Body Mass index 25-30 kg/m2
Minimum age
35 Years
Maximum age
54 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prexisting medical conditions under treatment
Hypertension
Allergy to fish or seafood
Using prescription pharmaceuticals, neutraceuticals, antioxidants or other supplements
Smoker
Planning to change level of exercise or fish intake during the course of the study

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number lists
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3624 0
New Zealand
State/province [1] 3624 0

Funding & Sponsors
Funding source category [1] 267231 0
University
Name [1] 267231 0
The University of Auckland, Liggins Institute
Country [1] 267231 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland, Liggins Institute
Address
2-6 Park Avenue
Grafton
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 266295 0
None
Name [1] 266295 0
Address [1] 266295 0
Country [1] 266295 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269222 0
Ethics committee address [1] 269222 0
Ethics committee country [1] 269222 0
Date submitted for ethics approval [1] 269222 0
14/06/2011
Approval date [1] 269222 0
Ethics approval number [1] 269222 0

Summary
Brief summary
Omega-3 supplements are very commonly used by people in the community for a multitude of purposes. Recent studies have suggested a way that they could improve the way the body processes sugar and in doing so reduce the risk of developing diabetes, and maybe help to treat it. However this has not been adequately tested in humans. This study aims to test this in an at risk group, middle aged males.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32726 0
Address 32726 0
Country 32726 0
Phone 32726 0
Fax 32726 0
Email 32726 0
Contact person for public queries
Name 15973 0
Dr Ben Albert
Address 15973 0
Liggins Institute, University of Auckland
2-6 Park Rd
Grafton
Auckland 1142
Country 15973 0
New Zealand
Phone 15973 0
+64 9 9231151
Fax 15973 0
Email 15973 0
[email protected]
Contact person for scientific queries
Name 6901 0
Dr Ben Albert
Address 6901 0
Liggins Institute, University of Auckland
2-6 Park Rd
Grafton
Auckland 1142
Country 6901 0
New Zealand
Phone 6901 0
+64 9 9231151
Fax 6901 0
Email 6901 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
EmbaseSupplementation with a blend of krill and salmon oil is associated with increased metabolic risk in overweight men.2015https://dx.doi.org/10.3945/ajcn.114.103028
N.B. These documents automatically identified may not have been verified by the study sponsor.