Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000659000
Ethics application status
Approved
Date submitted
12/08/2010
Date registered
12/08/2010
Date last updated
12/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of long chain omega-3 polyunsaturated fatty acids (fish oil) on weight management
Scientific title
Does supplementation with long chain omega-3 polyunsaturated fatty acids assist with weight management in obese individuals
Secondary ID [1] 252435 0
nil
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 257947 0
Condition category
Condition code
Diet and Nutrition 258114 258114 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A low kilojoule (kJ) diet of 5,000 to 6,000 kJ/day, based on the Australian Guide to Healthy Eating, will be followed for 12 weeks. Participants will also consume, by mouth, 6 x 1g/day fish oil capsules composed of 270mg Docosahexaenoic Acid (DHA) and 70mg Eicosapentaenoic Acid (EPA) per capsule. Participants then progress to weight maintenance for 10 weeks and continue to take the 6 x 1 g/day fish oil capsules.

Participants receive 1 x 30 minutes per week education sessions on dietary modification and behaviour change for the first four weeks of weight loss
Intervention code [1] 257001 0
Lifestyle
Intervention code [2] 257002 0
Behaviour
Intervention code [3] 257003 0
Treatment: Other
Comparator / control treatment
The control group follow the identical low kJ diet 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] 258977 0
Comparison of % change in total body fat from baseline between groups using bioelectrical impedance.
Timepoint [1] 258977 0
At baseline, at 12 weeks, at 22 weeks
Primary outcome [2] 258978 0
Comparison of % change in fat free mass from baseline between groups using bioelectrical impedance assessment
Timepoint [2] 258978 0
At baseline, at 12 weeks, at 22 weeks
Primary outcome [3] 258979 0
Comparison of % change in weight from baseline between groups using a calibrated balance beam scale to measure weight
Timepoint [3] 258979 0
At baseline, at 12 weeks, at 22 weeks
Secondary outcome [1] 265166 0
Comparison of changes in inflammatory biomarkers from baseline between groups using commerically available Enzyme Linked ImmunoSorbent Assays (ELISAs), namely Leptin, Adiponectin, Interleukin-6 (IL-6), Tumour Necrosis Factor alpha (TNFa) and Leukotriene B4 (LTB4). Also C-Reactive Protein which will be analysed by Hunter Area Pathology Services.
Timepoint [1] 265166 0
At baseline, at 12 weeks, at 22 weeks
Secondary outcome [2] 265167 0
Comparison of changes in blood glucose and blood lipids from baseline between groups. Fasting blood glucose and blood lipids will be analysed by Hunter Area Pathology Services.
Timepoint [2] 265167 0
At baseline, at 12 weeks, at 22 weeks
Secondary outcome [3] 265168 0
Comparison of changes in plasma fatty acids between groups. Plasma fatty acid profiles will be determined using Gas Chromatography analysis.
Timepoint [3] 265168 0
At baseline, at 12 weeks, at 22 weeks

Eligibility
Key inclusion criteria
Body Mass Index (BMI) between 30 and 40. Can consume fish. Can swallow capsules
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI >40; Diabetic; Already consuming fish oil capsules or 2 or more oily fish meals/week; Has an 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 that 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 computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
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] 257451 0
Self funded/Unfunded
Name [1] 257451 0
Professor Manohar Garg
Country [1] 257451 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 256682 0
Commercial sector/Industry
Name [1] 256682 0
NuMega Ingredients Pty Ltd
Address [1] 256682 0
31 Pinnacle Road, Altona North, Victoria 3025
Country [1] 256682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259479 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 259479 0
Ethics committee country [1] 259479 0
Australia
Date submitted for ethics approval [1] 259479 0
Approval date [1] 259479 0
14/12/2005
Ethics approval number [1] 259479 0
H-159-1205

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

Contacts
Principal investigator
Name 31517 0
Address 31517 0
Country 31517 0
Phone 31517 0
Fax 31517 0
Email 31517 0
Contact person for public queries
Name 14764 0
Irene Munro
Address 14764 0
School of Biomedical Sciences and Pharmacy.
The University of Newcastle, University Drive, Callaghan NSW 2308
Country 14764 0
Australia
Phone 14764 0
+61 2 4921 5638
Fax 14764 0
+61 2 4921 2028
Email 14764 0
[email protected]
Contact person for scientific queries
Name 5692 0
Professor Manohar Garg
Address 5692 0
School of Biomedical Sciences and Pharmacy.
The University of Newcastle, University Drive, Callaghan NSW 2308
Country 5692 0
Australia
Phone 5692 0
+61 2 4921 5647
Fax 5692 0
+61 2 4921 2028
Email 5692 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.