Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000750088
Ethics application status
Approved
Date submitted
25/08/2010
Date registered
9/09/2010
Date last updated
15/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Fish Oil Oral Supplementation on Fat Metabolism in Obese Subjects on a Weight Loss Diet.
Scientific title
The Effect of Oral Supplementation with n-3 Fatty Acid Ethyl Esters on Lipoprotein Metabolism in Obese Subjects on a Weight Loss Diet.
Secondary ID [1] 252581 0
Nil
Universal Trial Number (UTN)
Trial acronym
WIFA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidaemia 258055 0
Condition category
Condition code
Metabolic and Endocrine 258216 258216 0 0
Metabolic disorders
Diet and Nutrition 258242 258242 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 parallel groups.

Group 1 - Weight loss alone. Participants will undergo 12 weeks of weight loss followed by 4 weeks of weight maintenance. Over the 16 weeks, each participant will meet with a dietitian face-to-face every 2 weeks (each session approximately 30-60minutes) for professional dietary advice.

Group 2 - Weight loss plus Fish Oil. Participants will undergo 12 weeks of weight loss followed by 4 weeks of weight maintenance. Over the 16 weeks, each participant will meet with a dietitian face-to-face every 2 weeks (each session approximately 30-60minutes) for professional dietary advice. Throughout this 16 weeks period, participants will also be provided with n-3 fatty acid ethyl esters (Fish Oil) oral supplementation (4g/day) to be consumed daily.
Intervention code [1] 257087 0
Treatment: Other
Comparator / control treatment
Group 1. Weight loss alone
Control group
Active

Outcomes
Primary outcome [1] 259079 0
To examine the effect of n-3 fatty acid ethyl esters oral supplementation on Very-Low-Density-Lipoprotein (VLDL) transport in the background of weight loss. VLDL transport will be determined through blood analysis and compared between the two groups. All analysis will be carried out using Statistical Package for the Social Sciences (SPSS). Associations will be examined using simple regression method. Paired T-tests will be used to assess changes within both treatment groups for all variables. Differences between the groups prior to randomistation will be determined by one-way Analysis of Variance (ANOVA). Compartmental analysis will be used to develop and fit models to lipid and lipoprotein tracer data.
Timepoint [1] 259079 0
VLDL transport time points are baseline, 5, 10, 20, 30, 40, 60 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 24 hours following administration of D3-Leucine stable isotope and vitamin A capsules on 2 occasions. i.e. the beginning and end of the 16 weeks treatment period.
Secondary outcome [1] 265364 0
Markers of triglyceride-rich lipoprotein (triglycerides, apoB-48, retinyl palmitate) through blood analysis.
Timepoint [1] 265364 0
Baseline, 5, 10, 20, 30, 40, 60 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 24 hours following administration of D3-Leucine stable isotope and vitamin A capsules on 2 occasions. i.e. the beginning and end of the 16 weeks treatment period.
Secondary outcome [2] 265365 0
Forearm plethysmography: changes in forearm blood flow
Timepoint [2] 265365 0
The beginning and end of the 16 weeks treatment period.
Secondary outcome [3] 265366 0
Non-invasive measures of arterial stiffness (applanation tonometry and arterial pulse wave analysis)
Timepoint [3] 265366 0
The beginning and end of the 16 weeks treatment period.

Eligibility
Key inclusion criteria
Men and post-menopausal women aged 18-75 with Body Mass Index less than 45kg/m2 will be recruited. Post Menopausual will be defined by: no menstrual cycle for 1 year and Follicle Stimulating Hormone (FSH) greater than 30U/L, or if the subject has had a hysterectomy or surgical sterilisation. Central obesity will be defined as waist circumference greater than 88cm for women and greater than 102cm for men AND triglycerides greater than or equal to 1.5mmol/L and/or High-Density-Lipoprotein (HDL) cholesterol less than 1.0mmol/L for men and less than 1.3mmol/L for women.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with genetic hyperlipidemia, (eg Familial Hyperlipidemia, type III), Total cholesterol greater than 7mmol/L, proteinuria, hypothyroidism, alcoholism (greater than 30grams/day), creatinaemia (greater than 130micromol/L), hepatic dysfunction (Aspartate Transaminase (AST) or Alinine Transaminase (ALT) greater than 3 times the Upper Limit of Normal (ULN) and major systemic illness; pre-menopause women; use of steroids or other agents that may influence lipid metabolism, cardiovascular event within past 6 months, use of hypocaloric diets, anaemia; a history of intolerance to fish oil. Any gasto-intestinal surgery that would affect intestinal transit time and interpretation of postprandial lipaemia. Diabetics on medical management.

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)
Allocation involves contacting the person holding the allocation schedule and who is not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised sequence generated by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257538 0
Government body
Name [1] 257538 0
National Health and Medical Research Council (NHMRC) grant
Country [1] 257538 0
Australia
Primary sponsor type
Individual
Name
Professor Gerald Watts
Address
School of Medicine and Pharmacology
Royal Perth Hospital,
Rear 50 Murray Street
PO Box X2213,
Perth
WA 6847
Country
Australia
Secondary sponsor category [1] 256764 0
None
Name [1] 256764 0
Address [1] 256764 0
Country [1] 256764 0
Other collaborator category [1] 251462 0
Individual
Name [1] 251462 0
Dr. Dick Chan
Address [1] 251462 0
School of Medicine and Pharmacology
Royal Perth Hospital,
Rear 50 Murray Street
PO Box X2213,
Perth
WA 6847
Country [1] 251462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259567 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 259567 0
Ethics committee country [1] 259567 0
Australia
Date submitted for ethics approval [1] 259567 0
Approval date [1] 259567 0
10/08/2010
Ethics approval number [1] 259567 0
2010/074

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

Contacts
Principal investigator
Name 31571 0
Address 31571 0
Country 31571 0
Phone 31571 0
Fax 31571 0
Email 31571 0
Contact person for public queries
Name 14818 0
Sandra Hamilton
Address 14818 0
School of Medicine and Pharmacology
Royal Perth Hospital,
Rear 50 Murray Street
PO Box X2213,
Perth
WA 6847
Country 14818 0
Australia
Phone 14818 0
+61 8 9224 0318
Fax 14818 0
+61 8 9224 0246
Email 14818 0
[email protected]
Contact person for scientific queries
Name 5746 0
Dr. Dick Chan
Address 5746 0
School of Medicine and Pharmacology
Royal Perth Hospital,
Rear 50 Murray Street
PO Box X2213,
Perth
WA 6847
Country 5746 0
Australia
Phone 5746 0
+61 8 9224 0268
Fax 5746 0
+61 8 9224 0246
Email 5746 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
SourceTitleYear of PublicationDOI
Dimensions AISupplementation with n3 Fatty Acid Ethyl Esters Increases Large and Small Artery Elasticity in Obese Adults on a Weight Loss Diet2013https://doi.org/10.3945/jn.112.169359
N.B. These documents automatically identified may not have been verified by the study sponsor.