The role of long chain omega-3 polyunsaturated fatty acids on weight loss and maintenance

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000204246
• Date of registration: 23/04/2009
• Prospective Registration: No
• Primary sponsor: The University of Newcastle
• 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
• Date of first enrolment: 01/02/2009
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12609000204246.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Professor Manohar Garg

• Name: Irene Munro

Key inclusion & exclusion criteria

Inclusion criteria: Body Mass Index (BMI) between 30 and 40
Can consume fish
Can swalllow capsules
Exclusion criteria: BMI >40
Diabetic
Already consuming fish oil capsules or more than 2 oily fish meals/week
Has inflammatory condition

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Obesity;
Obesity

Diet and Nutrition - Obesity

Intervention(s)

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.

Primary Outcome(s)

Comparison of % change in total body fat from baseline between groups using bioelectrical impedance[At baseline, at 4 weeks and at 14 weeks, all within the treatment period]

Comparison of % change in fat free mass from baseline between groups using biolectrical impedance assessment[At baseline, at 4 weeks and at 14 weeks, all within the treatment period]

Comparison of % change in weight from baseline between groups using a calibrated balance beam scale to measure weight[At baseline, at 4 weeks and at 14 weeks, all within the treatment period]

Secondary Outcome(s)

Comparison of changes in all plasma lipids from baseline between groups. Plasma fatty acid profiles will be determined using Gas Chromatography analysis.[At baseline, at 4 weeks and at 14 weeks, all within the treatment period]

Comparison of changes in blood glucose from baseline between groups. Fasting blood glucose will be analysed by Hunter Area Pathology Services[At baseline, at 4 weeks and at 14 weeks, all within the treatment period]

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)[At baseline, at 4 weeks and at 14 weeks, all within the treatment period]

Source(s) of Monetary Support

Professor Manohar Garg

Secondary Sponsor(s)

Nestle Australia Ltd

Ethics review

Status: Not approved
Approval date:
Contact:

The University of Newcastle Human Research Ethics Committee