Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000983000
Ethics application status
Approved
Date submitted
12/11/2010
Date registered
15/11/2010
Date last updated
15/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot trial assessing the effect of fish oil on leptin and adiponectin levels in overweight/obese individuals.
Scientific title
A pilot trial assessing the effect of marine lipids on leptin and adiponectin levels in overweight/obese individuals.
Secondary ID [1] 1558 0
University of Queensland Ethics - 2010001200
Secondary ID [2] 1559 0
Princess Alexandra Hosipital Ethics (Metro South Health Service District Human Research Ethics Committee) - HREC/10/QPAH/141
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257064 0
Cardiovascular Disease 257065 0
Condition category
Condition code
Diet and Nutrition 257218 257218 0 0
Obesity
Cardiovascular 257219 257219 0 0
Other cardiovascular diseases
Metabolic and Endocrine 257220 257220 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment with commercially available marine lipid preparation at a dose of 4 x 1000mg capsules per day (each capsule contains 300mg EPA, 200mg DHA) for a period of 8 weeks
Intervention code [1] 256232 0
Prevention
Comparator / control treatment
Baseline data for participants will be utilised for control/comparative purposes
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258111 0
Changes in adiponectin levels measured via EDTA plasma ELISA assays
Timepoint [1] 258111 0
T0, T4 and T8 (weeks)
Primary outcome [2] 259652 0
Changes in leptin levels measured via EDTA plasma ELISA assays
Timepoint [2] 259652 0
T0, T4 and T8 (weeks)
Secondary outcome [1] 263732 0
Changes in Pathology results (ELFT, Omega 3 Indices, CRP, HbA1C)
Timepoint [1] 263732 0
T0, T4 and T8 (weeks)
Secondary outcome [2] 266322 0
Changes in anthropometric data (BMI, hip:waist ratio)
Timepoint [2] 266322 0
T0, T4 and T8 (weeks)
Secondary outcome [3] 266323 0
Results from International Physical Activity Questionaire (IPAQ)
Timepoint [3] 266323 0
T0, T4 and T8 (weeks)
Secondary outcome [4] 266329 0
Results from Fatigue Questionaire (FIS)
Timepoint [4] 266329 0
T0, T4 and T8 (weeks)
Secondary outcome [5] 266330 0
Results from Fatigue 3 day unannounced dietary recall
Timepoint [5] 266330 0
T0, T4 and T8 (weeks)

Eligibility
Key inclusion criteria
Participants will have a BMI of 25 or greater and be generally healthy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent use of other medications or investigational products;
Weight loss of more than 10% body weight within the last six months;
Active substance abuse (alcohol or drug dependency);
Breast feeding or pregnancy;
Smoking;
Allergies to fish oil supplements;
Major Health Conditions;
Concomitant use of anticoagulants or statin medications (Pravastatin).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through the general population including advertisements placed at Princess Alexendra and Mater Hospitals. All participants will receive the same treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256732 0
University
Name [1] 256732 0
Centre for Integrative Clinical and Molecular Medicine, University of Queensland
Country [1] 256732 0
Australia
Primary sponsor type
University
Name
Centre for Integrative Clinical and Molecular Medicine, University of Queensland
Address
Level 2, R-Wing
Princess Alexandra Hospital
Wooloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 257238 0
None
Name [1] 257238 0
Address [1] 257238 0
Country [1] 257238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260049 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 260049 0
Ethics committee country [1] 260049 0
Australia
Date submitted for ethics approval [1] 260049 0
Approval date [1] 260049 0
23/09/2010
Ethics approval number [1] 260049 0
2010001200
Ethics committee name [2] 260050 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [2] 260050 0
Centres for Health Research (Contracts)
Level 2, Building 35
Princess Alexandra Hospital
Ipswich Road, Wooloongabba
Ethics committee country [2] 260050 0
Australia
Date submitted for ethics approval [2] 260050 0
Approval date [2] 260050 0
22/09/2010
Ethics approval number [2] 260050 0
HREC/10/QPAH/141

Summary
Brief summary
Obesity is a global epidemic. It is associated with a high burden of chronic diseases such as type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD) and some cancers. Obesity and CVD progression have been associated with altered levels of biologically active proteins secreted by adipocytes, including the hormones adiponectin and leptin.
This study aims to assess the effect of a high dose marine lipid supplement [dose: 4000mg per day for 8 weeks] on plasma adiponectin and leptin levels in overweight and obese individuals.
Trial website
Trial related presentations / publications
Gray B, Vitetta L, Colquhoun D, et al. A pilot trial assessing the effects of marine lipids on leptin and adiponectin levels in overweight/obese individuals. 19th annual RBWH Health Care Symposium. Royal Brisbane and Women's Hospital, Brisbane2010:Poster Number 22-CS.
Public notes

Contacts
Principal investigator
Name 30998 0
Address 30998 0
Country 30998 0
Phone 30998 0
Fax 30998 0
Email 30998 0
Contact person for public queries
Name 14245 0
Associate Professor Luis Vitetta
Address 14245 0
Centre for Integrative Clinical and Molecular Medicine
University of Queensland
Level 2, R-Wing
Princess Alexandra Hospital
Ipswich Road
Wooloongabba QLD 4102
Country 14245 0
Australia
Phone 14245 0
61 7 3176 2903
Fax 14245 0
61 7 3176 6858
Email 14245 0
[email protected]
Contact person for scientific queries
Name 5173 0
Associate Professor Luis Vitetta
Address 5173 0
Centre for Integrative Clinical and Molecular Medicine
University of Queensland
Level 2, R-Wing
Princess Alexandra Hospital
Wooloongabba QLD 4102
Country 5173 0
Australia
Phone 5173 0
61 7 3176 2903
Fax 5173 0
61 7 3176 6858
Email 5173 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.