Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000204246
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
23/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of long chain omega-3 polyunsaturated fatty acids on weight loss and maintenance
Scientific title
Does supplementation with long chain omega-3 polyunsaturated fatty acids assist with weight loss and weight maintenance in obese individuals
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 3200 0
Condition category
Condition code
Diet and Nutrition 3363 3363 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A very low Kilojoule (kJ) diet (VLCD) of 3,000 kJ, using meal replacements, will be followed for 4 weeks. The meal replacements will be supplied to participants as part of the study. Participants will also consume, by mouth, 6 x 1g/day fish oil capsules composed of 270mg Docosahexaenoic Acid (DHA) and 70mg Eicosapentaenoic Acid (EPA) /capsule. Participants then progress to weight maintenance for 10 weeks and continue to take the 6 x 1g/day fish oil capsules.

Participants receive 1 x 20 minutes per week individual education sessions on dietary modification and behaviour change for the four weeks of weight loss.
Intervention code [1] 2936 0
Lifestyle
Intervention code [2] 2937 0
Behaviour
Comparator / control treatment
The control group follow identical VLCD with nutrition education and then weight maintenance with 6 x 1g/day capsules monounsaturated oil (placebo), to be taken by mouth.
Control group
Placebo

Outcomes
Primary outcome [1] 4249 0
Comparison of % change in total body fat from baseline between groups using bioelectrical impedance
Timepoint [1] 4249 0
At baseline, at 4 weeks and at 14 weeks, all within the treatment period
Primary outcome [2] 5424 0
Comparison of % change in fat free mass from baseline between groups using biolectrical impedance assessment
Timepoint [2] 5424 0
At baseline, at 4 weeks and at 14 weeks, all within the treatment period
Primary outcome [3] 5425 0
Comparison of % change in weight from baseline between groups using a calibrated balance beam scale to measure weight
Timepoint [3] 5425 0
At baseline, at 4 weeks and at 14 weeks, all within the treatment period
Secondary outcome [1] 7180 0
Comparison of changes in inflammatory biomarkers from baseline between groups using commercially available Enzyme Linked ImmunoSorbent Assays (ELISAs), namely, Leptin, Adiponectin, Interleukin-6 (IL-6), Tumour Necrosis Factor alpha (TNFa) and Leukotriene B4 (LTB4)
Timepoint [1] 7180 0
At baseline, at 4 weeks and at 14 weeks, all within the treatment period
Secondary outcome [2] 9119 0
Comparison of changes in blood glucose from baseline between groups. Fasting blood glucose will be analysed by Hunter Area Pathology Services
Timepoint [2] 9119 0
At baseline, at 4 weeks and at 14 weeks, all within the treatment period
Secondary outcome [3] 9120 0
Comparison of changes in all plasma lipids from baseline between groups. Plasma fatty acid profiles will be determined using Gas Chromatography analysis.
Timepoint [3] 9120 0
At baseline, at 4 weeks and at 14 weeks, all within the treatment period

Eligibility
Key inclusion criteria
Body Mass Index (BMI) between 30 and 40
Can consume fish
Can swalllow capsules
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
BMI >40
Diabetic
Already consuming fish oil capsules or more than 2 oily fish meals/week
Has inflammatory condition

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)
Double blind randomised control trial. Participant recruitment from the general public through the media. Participants complete a health questionnaire to ensure inclusion criteria are met. Randomisation of participants to one of the two groups and coding of fish oil and placebo capsules performed by independent researcher.
Allocation was concealed by using numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to fish oil or placebo group conducted by independent researcher using a randomisation table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2009
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] 4483 0
Self funded/Unfunded
Name [1] 4483 0
Professor Manohar Garg
Country [1] 4483 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 4047 0
Commercial sector/Industry
Name [1] 4047 0
Nestle Australia Ltd
Address [1] 4047 0
341 George Street
Sydney NSW 2000
Country [1] 4047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6804 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 6804 0
Ethics committee country [1] 6804 0
Australia
Date submitted for ethics approval [1] 6804 0
Approval date [1] 6804 0
Ethics approval number [1] 6804 0
H-159-1205

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

Contacts
Principal investigator
Name 28624 0
Address 28624 0
Country 28624 0
Phone 28624 0
Fax 28624 0
Email 28624 0
Contact person for public queries
Name 11781 0
Irene Munro
Address 11781 0
School of Biomedical Sciences
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 11781 0
Australia
Phone 11781 0
+61 2 4921 5638
Fax 11781 0
Email 11781 0
[email protected]
Contact person for scientific queries
Name 2709 0
Professor Manohar Garg
Address 2709 0
School of Biomedical Sciences
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 2709 0
Australia
Phone 2709 0
+61 2 4921 5647
Fax 2709 0
Email 2709 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.