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Trial registered on ANZCTR


Registration number
ACTRN12610000654055
Ethics application status
Approved
Date submitted
10/08/2010
Date registered
11/08/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of long chain omega-3 polyunsaturated fatty acids (fish oil) on weight loss
Scientific title
Does presupplementation and then supplementation with long chain omega-3 polyunsaturated fatty acids assist with weight loss during a low kilojoule diet with obese individuals
Secondary ID [1] 252410 0
nil
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 257918 0
Condition category
Condition code
Diet and Nutrition 258093 258093 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume, by mouth, 6 x 1 g/day fish oil capsules composed of 270mg docosahexaenoic acid (DHA) and 70mg eicosapentaenoic acid (EPA)/capsule for four weeks while following a normal, healthy diet, ie. their normal diet without fast foods/take away foods. Participants will then consume a very low Kilojoule (kJ) diet (VLCD) of 3,000 kJ/day using meal replacements for four weeks while continuing to consume 6 x 1g/day fish oil capsules, also for four weeks. The meal replacements will be supplied to participants as part of the study.

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] 256976 0
Lifestyle
Intervention code [2] 256977 0
Behaviour
Intervention code [3] 256992 0
Treatment: Other
Comparator / control treatment
Participants will consume, by mouth, 6 x 1 g/day monounsaturated oil (placebo) capsules for four weeks while following a normal, healthy diet. Participants will then consume a very low Kilojoule (kJ) diet (VLCD) of 3,000 kJ using meal replacements for four weeks while continuing to consume 6 x 1g/day placebo capsules, also for four weeks. The meal replacements will be supplied to participants as part of the study.

Participants receive 1 x 20 minutes per week individual education sessions on dietary modification and behaviour change for the four weeks of weight loss.
Control group
Placebo

Outcomes
Primary outcome [1] 258950 0
Comparison of % change in weight from baseline between groups using a calibrated balance beam scale to measure weight
Timepoint [1] 258950 0
At baseline, at 4 weeks and at 8 weeks, all within the treatment period
Primary outcome [2] 258952 0
Comparison of % change in total body fat from baseline between groups using bioelectrical impedance
Timepoint [2] 258952 0
At baseline, at 4 weeks and at 8 weeks, all within the treatment period
Primary outcome [3] 258953 0
Comparison of % change in fat free mass from baseline between groups using bioelectrical impedance
Timepoint [3] 258953 0
At baseline, at 4 weeks and at 8 weeks, all within the treatment period
Secondary outcome [1] 265117 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 Factors alpha (TNFa). Also C-reactive protein which will be analysed by Hunter Area Pathology Services
Timepoint [1] 265117 0
At baseline, at 4 weeks and at 8 weeks, all within the treatment period
Secondary outcome [2] 265119 0
Comparison of changes in blood glucose from baseline between groups. Fasting blood glucose will be analysed by Hunter Area Pathology Services
Timepoint [2] 265119 0
At baseline, at 4 weeks and at 8 weeks, all within the treatment period
Secondary outcome [3] 265120 0
Comparison of changes in plasma fatty acids which will be determined using gas chromatography analysis
Timepoint [3] 265120 0
At baseline, at 4 weeks and at 8 weeks, all within the treatment period

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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI > 40; Diabetic; Already consuming fish oil caplsules or more than 2 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 an 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 an 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
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] 257430 0
Self funded/Unfunded
Name [1] 257430 0
Professor Manohar Garg
Address [1] 257430 0
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308
Country [1] 257430 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 256660 0
Commercial sector/Industry
Name [1] 256660 0
Nestle Australia Litd
Address [1] 256660 0
341 George Street
Sydney NSW 2000
Country [1] 256660 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259451 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 259451 0
Research Office, The Chancellery
The University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [1] 259451 0
Australia
Date submitted for ethics approval [1] 259451 0
Approval date [1] 259451 0
Ethics approval number [1] 259451 0
H-159-1205

Summary
Brief summary
Weight gain has been associated with increased inflammation and n-3 long chain polyunsaturated fatty acids (fish oil) supplementation have been shown to possess anti-inflammatory properties. This study is investigating whether presupplementation with fish oil, then followed by supplementation with fish oil while following a weight loss program, may assist weight loss and reduce inflammatory biomarkers
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31498 0
Address 31498 0
Country 31498 0
Phone 31498 0
Fax 31498 0
Email 31498 0
Contact person for public queries
Name 14745 0
Irene Munro
Address 14745 0
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 14745 0
Australia
Phone 14745 0
+61 2 4921 5638
Fax 14745 0
61 2 4921 2028
Email 14745 0
Irene.Munro@uon.edu.au
Contact person for scientific queries
Name 5673 0
Professor Manohar Garg
Address 5673 0
School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 5673 0
Australia
Phone 5673 0
+61 2 4921 5647
Fax 5673 0
Email 5673 0
Manohar.Garg@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results