Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000962730
Ethics application status
Approved
Date submitted
28/08/2013
Date registered
29/08/2013
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Date results information initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary Fats and Biomarkers of Human Health: Excess Saturated Fat or Lack of Omega 3 Fatty Acids (Chronic Study)
Scientific title
Would it be an excess of saturated fat in the diet or a deficiency of omega-3 fatty acids the responsible for increased blood lipid levels? And what would be the effect of the background diet on omega-3 supplementation in healthy adults in a chronic study?
Secondary ID [1] 283094 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lipid levels 289931 0
systemic inflammation 289949 0
platelet agreggation 289950 0
Condition category
Condition code
Cardiovascular 290303 290303 0 0
Coronary heart disease
Diet and Nutrition 290304 290304 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 290305 290305 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled, dietary intervention trial, in parallel design with healthy adults. Blood samples will be collected at baseline and after 6 weeks of dietary intervention with omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation either in combination with saturated fat or omega-6 Polyunsaturated fatty acids (n-6 PUFA). The saturated fat group will consume butter (24g, which can be spread on bread, muffins or crackers), white chocolate (40g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods containing saturated fat for cooking.Participants will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken in each of their visits. Subjects will also complete a 3 day food record.
Intervention code [1] 287811 0
Prevention
Comparator / control treatment
This is a randomised controlled, dietary intervention trial, in parallel design with healthy adults. Blood samples will be collected at baseline and after 6 weeks of dietary intervention with omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation either in combination with saturated fat or omega-6 Polyunsaturated fatty acids (n-6 PUFA). The n-6 PUFA group will consume margarine (20g, which can be spread on bread, muffins or crackers), sunflower seeds (42g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods and oils containing n-6PUFA for cooking. Participants will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken in each of their visits. Subjects will also complete a 3 day food record.
Control group
Active

Outcomes
Primary outcome [1] 290341 0
Incorporation of fatty acids into erytrocytes will be assessed using gas chromatography
Timepoint [1] 290341 0
At baseline and after 6 weeks
Primary outcome [2] 290342 0
lipid profile (Trigycerides and total, LDL and HDL cholesterol) will be assessed using enzymatic colorimetric techniques.
Timepoint [2] 290342 0
At baseline and after 6 weeks
Secondary outcome [1] 304330 0
Inflammation markers (IL-6, TNF-alpha and hsCRP) will be assessed using ELISA.
Timepoint [1] 304330 0
At baseline and after 6 weeks
Secondary outcome [2] 304331 0
Platelet agreggation markers (Thromboxane A2, E-Selectine) will be assessed using ELISA.
Timepoint [2] 304331 0
At baseline and after 6 weeks

Eligibility
Key inclusion criteria
Healthy male or female aged between 18 and 65 years at initial assessment
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they satisfy any of the following criteria:
Are current using lipid-lowering drugs (eg statins), fish oil supplements or anti-inflamatory drugs;
Have a current regular consumption of 2 or more fish meals a week;
Have history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD;
Have history of diabetes, triglycerides higher than 10 mmol/L; LDL cholesterol higher than 5 mmol/L;
Have history of gastrointestinal/liver disease;
Are current smokers;
Are pregnant or breast feeding women

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)
Participants will be recruited from the general public through media advertising, advertisements placed on noticeboards at the University of Newcastle and distributed via departmental and faculty email lists. Participants will also be recruited from the Hunter Medical Research Institute (HMRI) Volunteer Register. Participants will complete a health questionnaire to ensure that inclusion criteria are met. Randomisation of participants to one of the group diets will be performed by one of the researchers in the researsh group. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to one of the group diets will be performed by one of the researchers in the research group using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
This study aims to demonstrate that total cholesterol in group A (dairy fat) is not higher than group B (n-6 PUFA) after 6 weeks of intervention and therefore it is a non-inferiority trial. Dietary fat manipulation (saturated versus n-6PUFA) increases plasma total cholesterol by 5% (0.3 mmol/L) within 6 weeks [1]. Therefore, assuming SD=0.5 mmol/L and non-inferiority margin of 0.25 mmol/L, 45 subjects per group will provide 80% power to demonstrate that group A doesn’t have higher total cholesterol (i.e. non-inferior) than group B (a= 0.05). Allowing for 10% dropouts, we will recruit n=100.
[1] Karvonen, H.M., et al., European Journal of Clinical Nutrition, 2002. 56(11): p. 1094-1101.

Statistical analysis:
Statistical analysis will be performed using the statistical software StataIC 11.2 (StataCorp LP).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
Actual
28/07/2014
Date of last data collection
Anticipated
Actual
8/09/2014
Sample size
Target
100
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25733 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 287850 0
Self funded/Unfunded
Name [1] 287850 0
Professor Manohar Garg 
Country [1] 287850 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 286580 0
None
Name [1] 286580 0
Address [1] 286580 0
Country [1] 286580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289792 0
University of Newcastle Human Research Ethics Committee 
Ethics committee address [1] 289792 0
Researsh Office
The Chancellery of University of Newcastle
University Drive
Callaghan NSW 2308 
Ethics committee country [1] 289792 0
Australia
Date submitted for ethics approval [1] 289792 0
Approval date [1] 289792 0
29/05/2012
Ethics approval number [1] 289792 0
H-2012-0117 

Summary
Brief summary
Consumption of foods rich in saturated fats have been associated with elevated blood lipid levels and adverse health effects. However studies using animal models have demonstrated that dietary saturated fats raise blood lipid (cholesterol and triglyceride) levels only when the diet is deficient in n-3 PUFA. If the same is true for humans, this research will have important implications for the prevention of cardiovascular and other chronic diseases. Therefore we hypothesise that saturated fat consumption does not raise blood lipid levels if the diet is sufficient in omega-3 polyunsaturated fatty acids. We also hypothesise that the benefits of n-3 PUFA can be optimised when consumed in combination with saturated fats. This is a randomised controlled, dietary intervention trial, in parallel design with healthy adults. Blood samples will be collected at baseline and after 6 weeks of dietary intervention with omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation either in combination with saturated fat or omega-6 Polyunsaturated fatty acids (n-6 PUFA). The saturated fat group will consume butter (24g, which can be spread on bread, muffins or crackers), white chocolate (40g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods containing saturated fat for cooking. The n-6 PUFA group will consume margarine (20g, which can be spread on bread, muffins or crackers), sunflower seeds (42g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods and oils containing n-6PUFA for cooking. Participants will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken in each of their visits. Subjects will also complete a 3 day food record.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42434 0
Prof Manohar Garg
Address 42434 0
School of Biomedical Sciences and Pharmacy,
Medical Sciences Building,
The University of Newcastle,
University Drive,
Callaghan NSW 2308
Country 42434 0
Australia
Phone 42434 0
+61 2 4921 5647
Fax 42434 0
+61 2 4921 2028
Email 42434 0
[email protected]
Contact person for public queries
Name 42435 0
Mrs Cintia Dias
Address 42435 0
School of Biomedical Sciences and Pharmacy,
Medical Sciences Building,
The University of Newcastle,
University Drive,
Callaghan NSW 2308
Country 42435 0
Australia
Phone 42435 0
+61 2 4921 5638
Fax 42435 0
+61 2 4921 2028
Email 42435 0
[email protected]
Contact person for scientific queries
Name 42436 0
Prof Manohar Garg
Address 42436 0
School of Biomedical Sciences and Pharmacy,
Medical Sciences Building,
The University of Newcastle,
University Drive,
Callaghan NSW 2308
Country 42436 0
Australia
Phone 42436 0
+61 2 4921 5647
Fax 42436 0
+61 2 4921 2028
Email 42436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethical approval for sharing IPD.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.