Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000351011
Ethics application status
Approved
Date submitted
8/04/2010
Date registered
3/05/2010
Date last updated
1/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of combined fish oil and coenzyme Q10 supplementation on liver fat composition, liver fat content and cardiovascular risk factors in overweight men
Scientific title
Effect of combined fish oil and coenzyme Q10 versus placebo on hepatic triglyceride concentration in overweight men
Secondary ID [1] 1584 0
none
Universal Trial Number (UTN)
U1111-1114-6507
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatic steatosis 257111 0
Condition category
Condition code
Metabolic and Endocrine 257265 257265 0 0
Other metabolic disorders
Oral and Gastrointestinal 257414 257414 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 capsules (4g) per day for 12 weeks to be consumed orally of docosahexaenoic fatty acid supplement (total dose of 1g of eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] combined and 200mg of coenzyme Q10 [CoQ10]/day)
Intervention code [1] 256275 0
Prevention
Comparator / control treatment
4 capsules (4g) per day for 12 weeks to be consumed orally of placebo (olive oil)
Control group
Placebo

Outcomes
Primary outcome [1] 258181 0
Hepatic triglyceride concentration (measured by localised proton magnetic resonance spectroscopy)
Timepoint [1] 258181 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [1] 263816 0
Hepatic triglyceride composition (magnetic resonance spectroscopy)
Timepoint [1] 263816 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [2] 264040 0
visceral adiposity (magnetic resonance imaging)
Timepoint [2] 264040 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [3] 264041 0
fasting plasma triglycerides (blood analysis)
Timepoint [3] 264041 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [4] 264042 0
cholesterol (blood analysis)
Timepoint [4] 264042 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [5] 264043 0
High Density Lipoprotein-cholesterol (blood analysis)
Timepoint [5] 264043 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [6] 264044 0
Apolipoprotein A-I (blood analysis)
Timepoint [6] 264044 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [7] 264045 0
serum biochemistry (blood analysis)
Timepoint [7] 264045 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [8] 264046 0
insulin (blood analysis)
Timepoint [8] 264046 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [9] 264047 0
Glycated haemoglobin (HbA1c) (blood analysis)
Timepoint [9] 264047 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [10] 264048 0
Plasma adiponectin (blood analysis)
Timepoint [10] 264048 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [11] 264049 0
High-sensitivity C-reactive protein (blood analysis)
Timepoint [11] 264049 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [12] 335554 0
Fasting liver enzymes (alanine aminotransferase, ALT; aspartate aminotransferase, AST; gamma-glutamyl transferase GGT) (blood analysis)
Timepoint [12] 335554 0
baseline, 6 weeks, 12 weeks

Eligibility
Key inclusion criteria
Overweight men: body mass index (BMI) greater than 25 but less than 30 with a waist circumference greater than or equal to 94cm.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
history of heart, lung or kidney disease; smoking and excess alcohol consumption; known allergy to fish or other seafood; a haemorrhagic disorder, or receiving anticoagulants and/or other drugs affecting coagulation; hepatic impairment (i.e., severe liver enzyme elevation); supplements or medications known to affect outcome measures.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subjects will be allocated. Allocation will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible subjects will be randomly assigned to the docosahexaenoic acid (DHA) supplement or placebo using computer generated random numbers tables.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
7/06/2011
Date of last participant enrolment
Anticipated
Actual
7/04/2014
Date of last data collection
Anticipated
Actual
15/07/2014
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256779 0
Commercial sector/Industry
Name [1] 256779 0
Blackmores
Country [1] 256779 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
East Street Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 256055 0
Other
Name [1] 256055 0
Heart Research Institute
Address [1] 256055 0
7 Eliza St Newtown, NSW 2042
Country [1] 256055 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258799 0
The Sydney South West Area Health Service (SSWAHS) Ethics Review Committee (Royal Prince Alfred Hospital [RPAH] Zone)
Ethics committee address [1] 258799 0
Ethics committee country [1] 258799 0
Australia
Date submitted for ethics approval [1] 258799 0
21/04/2010
Approval date [1] 258799 0
27/05/2010
Ethics approval number [1] 258799 0

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

Contacts
Principal investigator
Name 31030 0
Address 31030 0
Country 31030 0
Phone 31030 0
Fax 31030 0
Email 31030 0
Contact person for public queries
Name 14277 0
Helen Parker
Address 14277 0
Discipline of Exercise and Sport Science Faculty of Health Sciences
The University of Sydney
East Street Lidcombe NSW 2141
Country 14277 0
Australia
Phone 14277 0
+61 0401834392
Fax 14277 0
Email 14277 0
[email protected]
Contact person for scientific queries
Name 5205 0
Dr Nathan Johnson
Address 5205 0
Discipline of Exercise and Sport Science Faculty of Health Sciences
The University of Sydney
East Street Lidcombe NSW 2141
Country 5205 0
Australia
Phone 5205 0
+61 02 9351 9317
Fax 5205 0
Email 5205 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
EmbaseNAFLD in clinical practice: Can simple blood and anthropometric markers be used to detect change in liver fat measured by 1H-MRS?.2017https://dx.doi.org/10.1111/liv.13488
EmbaseEffect of fish oil supplementation on hepatic and visceral fat in overweight men: A randomized controlled trial.2019https://dx.doi.org/10.3390/nu11020475
N.B. These documents automatically identified may not have been verified by the study sponsor.