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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]

nil

Universal Trial Number (UTN)

Trial acronym

nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

Condition category

Condition code

Diet and Nutrition

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

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]

Comparison of % change in weight from baseline between groups using a calibrated balance beam scale to measure weight

Timepoint [1]

At baseline, at 4 weeks and at 8 weeks, all within the treatment period

Primary outcome [2]

Comparison of % change in total body fat from baseline between groups using bioelectrical impedance

Timepoint [2]

At baseline, at 4 weeks and at 8 weeks, all within the treatment period

Primary outcome [3]

Comparison of % change in fat free mass from baseline between groups using bioelectrical impedance

Timepoint [3]

At baseline, at 4 weeks and at 8 weeks, all within the treatment period

Secondary outcome [1]

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]

At baseline, at 4 weeks and at 8 weeks, all within the treatment period

Secondary outcome [2]

Comparison of changes in blood glucose from baseline between groups. Fasting blood glucose will be analysed by Hunter Area Pathology Services

Timepoint [2]

At baseline, at 4 weeks and at 8 weeks, all within the treatment period

Secondary outcome [3]

Comparison of changes in plasma fatty acids which will be determined using gas chromatography analysis

Timepoint [3]

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

Sex

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

15/01/2010

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]

Self funded/Unfunded

Name [1]

Professor Manohar Garg

Address [1]

School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308

Country [1]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Address

University Drive, Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Nestle Australia Litd

Address [1]

341 George Street
Sydney NSW 2000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Research Office, The Chancellery
The University of Newcastle
University Drive
Callaghan   NSW   2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Irene Munro

Address

School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 5638

Fax

61 2 4921 2028

Email

[email protected]

Contact person for scientific queries

Name

Professor Manohar Garg

Address

School of Biomedical Sciences and Pharmacy
The University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 5647

Fax

Email

[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	Prior supplementation with long chain omega-3 polyunsaturated fatty acids promotes weight loss in obese adults: a double-blinded randomised controlled trial	2013	https://doi.org/10.1039/c3fo60038f

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