Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000566437
Ethics application status
Approved
Date submitted
12/10/2007
Date registered
5/11/2007
Date last updated
5/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long Chain Omega-3 Polyunsaturated Fatty Acids and Heart Health in Humans
Scientific title
A randomised dose-response trial to determine the effects of omega-3 fatty acids in treatment of mild hypertriglyceridemia in young women to reduce the risk of cardiovascular disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild hypertriglyceridaemic subjects 2447 0
Condition category
Condition code
Cardiovascular 2551 2551 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a dose-response study therefore participants will be randomized to one of 4 dose groups (0, 0.3, 0.7 or 1.0g/day) of long chain omega-3 fatty acids (Nu-Mega DHA-rich tuna oil capsules, 500mg).
Duration is 2 menstrual cycles (approximately 8 weeks).
0.3g/day group consumes 2 tuna oil capsules and 4 placebo capsules per day; the 0.7g/day group consumes 4 tuna oil capsules and 2 placebo capsules per day; and the 1.0g/day group consumes 6 tuna oil capsules per day. These 3 dose groups will be compared to 1 placebo group which consumes 6 placebo capsules per day (Sunola oil).
Intervention code [1] 2178 0
Treatment: Other
Comparator / control treatment
Placebo Sunola capsules, taken for 2 menstrual cycles (approximately 8 weeks). 0g/day long chain omega-3 polyunsaturated fatty acid (LCn3PUFA) group will consume only placebo capsules (6 per day).
Control group
Placebo

Outcomes
Primary outcome [1] 3457 0
Fasting plasma triglycerides (measured using an autoanalyser (Konelab, Thermo Electron) and standard assay kits.
Timepoint [1] 3457 0
At baseline and approximately 8 weeks after start of intervention (2 menstrual cycles)
Secondary outcome [1] 5761 0
Lipoprotein levels and particle size (VLDL, IDL, LDL and HDL). Lipoproteins will be isolated from plasma using sequential ultracentrifugation. Particle size will be determined using gradient gel electrophoresis, and composition analysis will be conducted using an autoanalyser.
Timepoint [1] 5761 0
At baseline and approximately 8 weeks after start of intervention (2 menstrual cycles)
Secondary outcome [2] 5762 0
Fatty acid profile of erythrocytes, plasma and whole blood from the fingertip.
Timepoint [2] 5762 0
At baseline and approximately 8 weeks after start of intervention (2 menstrual cycles)
Secondary outcome [3] 5763 0
Blood pressure
Timepoint [3] 5763 0
At baseline and approximately 8 weeks after start of intervention (2 menstrual cycles)
Secondary outcome [4] 5764 0
Glucose and insulin levels, which will be meaured using Enzyme-Linked ImmunoSorbent Assay (ELISA)
Timepoint [4] 5764 0
At baseline and approximately 8 weeks after start of intervention (2 menstrual cycles)

Eligibility
Key inclusion criteria
Female, generally healthy, regular menstrual cycles, plasma triglycerides >1.0mmol/L at screening visit.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant, irregular menstrual cycles, anemia, or plasma triglycerides < 1mmol/L at screening visit.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer Software Microsoft Excel
Stratified Allocation based on age, body mass index (BMI) and contraceptive pill use
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
Recruiting
Date of first participant enrolment
Anticipated
10/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 276 0
2500

Funding & Sponsors
Funding source category [1] 2697 0
Government body
Name [1] 2697 0
Australian Research Council Australian Postgraduate Award-Industry (ARC APA-I)
Country [1] 2697 0
Australia
Funding source category [2] 2698 0
Commercial sector/Industry
Name [2] 2698 0
Nu-Mega Ingredients (now Clover Corporation)
Country [2] 2698 0
Australia
Funding source category [3] 2699 0
Commercial sector/Industry
Name [3] 2699 0
Analytical Reference Laboratories
Country [3] 2699 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 2442 0
None
Name [1] 2442 0
Address [1] 2442 0
Country [1] 2442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4619 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 4619 0
Ethics committee country [1] 4619 0
Australia
Date submitted for ethics approval [1] 4619 0
Approval date [1] 4619 0
01/02/2007
Ethics approval number [1] 4619 0
HE06/317

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

Contacts
Principal investigator
Name 28109 0
Address 28109 0
Country 28109 0
Phone 28109 0
Fax 28109 0
Email 28109 0
Contact person for public queries
Name 11266 0
Cassandra Sparkes
Address 11266 0
School of Health Sciences
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 11266 0
Australia
Phone 11266 0
02 4221 4274
Fax 11266 0
02 4221 3486
Email 11266 0
[email protected]
Contact person for scientific queries
Name 2194 0
Cassandra Sparkes
Address 2194 0
School of Health Sciences
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 2194 0
Australia
Phone 2194 0
02 4221 4274
Fax 2194 0
02 4221 3486
Email 2194 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
EmbaseEffect of low dose docosahexaenoic acid-rich fish oil on plasma lipids and lipoproteins in pre-menopausal women: A dose-response randomized placebo-controlled trial.2018https://dx.doi.org/10.3390/nu10101460
EmbaseFingertip whole blood as an indicator of omega-3 long-chain polyunsaturated fatty acid changes during dose-response supplementation in women: Comparison with plasma and erythrocyte fatty acids.2021https://dx.doi.org/10.3390/nu13051419
N.B. These documents automatically identified may not have been verified by the study sponsor.