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Trial registered on ANZCTR


Registration number
ACTRN12614001051639
Ethics application status
Approved
Date submitted
24/09/2014
Date registered
2/10/2014
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
Retrospectively registered

Titles & IDs
Public title
Dietary Fats and Biomarkers of Human Health: Excess Saturated Fat or Lack of Omega 3 Fatty Acids (Second 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 in healthy adults consuming adequate omega-3 Polyunsaturated fatty acids?
Secondary ID [1] 285243 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lipid levels 292882 0
systemic inflammation 293167 0
Condition category
Condition code
Cardiovascular 293174 293174 0 0
Coronary heart disease
Diet and Nutrition 293175 293175 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 293176 293176 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be asked to consume 4x1g fish oil capsules (2.4g EPA:DHA 100:500) daily for 4 weeks; then they will be randomly assigned to one of two diets, either a high saturated fat (SFA) diet or a high n-6PUFA diet, both combined with n-3PUFA (fish oil), which they will consume for 10 days. Subjects on the saturated fat diet will consume daily 24g butter (which can be spread on bread, muffins or crackers), 40g white chocolate and 4x1g fish oil capsules; they will also be advised on how to use more foods containing saturated fat for cooking and reduce n-6PUFA containing oils. The patients will donate blood, give information on medical and supplement usage and physical activity and they will have their anthropometric measurements taken, at baseline, at 4 weeks and after 10 days of consuming the SFA diet. Subjects will also complete a 3 day food record, at baseline, at 4 weeks and after 10 days of consuming the SFA diet.
Intervention code [1] 290126 0
Prevention
Comparator / control treatment
Subjects will be asked to consume 4x1g fish oil capsules (2.4g EPA:DHA 100:500) daily for 4 weeks; then they will be randomly assigned to one of two diets, either a high saturated fat (SFA) diet or a high n-6PUFA diet, both combined with n-3PUFA (fish oil), which they will consume for 10 days. Subjects on the n-6PUFA diet will consume daily 20g margarine (which can be spread on bread, muffins or crackers), 24g sunflower seeds and 4x1g fish oil capsules; they will also be advised on how to use more foods and oils containing n-6PUFA for cooking and reduce saturated fat consumption. The patients will donate blood, give information on medical and supplement usage and physical activity and they will have their anthropometric measurements taken, at baseline, at 4 weeks and after 10 days of consuming the n-6PUFA diet. Subjects will also complete a 3 day food record, at baseline, at 4 weeks and after 10 days of consuming the n-6PUFA diet.
Control group
Active

Outcomes
Primary outcome [1] 293039 0
Incorporation of fatty acids into erytrocytes will be assessed using gas chromatography.
Timepoint [1] 293039 0
At baseline, 4 weeks and after 10 day of consuming either the high SFA diet or the high n-6pufa diet.
Primary outcome [2] 293040 0
lipid profile (Triglycerides and total, LDL and HDL cholesterol) will be assessed using enzymatic colorimetric techniques.
Timepoint [2] 293040 0
At baseline, 4 weeks and after 10 day of consuming either the high SFA diet or the high n-6pufa diet.
Secondary outcome [1] 310226 0
Inflammation markers (IL-6, TNF-alpha and hsCRP) will be assessed using ELISA.
Timepoint [1] 310226 0
At baseline, 4 weeks and after 10 day of consuming either the high SFA diet or the high n-6pufa diet.
Secondary outcome [2] 310227 0
Platelet aggregation markers (Thromboxane A2, E-Selectine) will be
assessed using ELISA.
Timepoint [2] 310227 0
At baseline, 4 weeks and after 10 day of consuming either the high SFA diet or the high n-6pufa diet.

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
Gender
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 currently 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 disorder
Have history of 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. Randomization of participants to one of the group diets will be performed by one of the researchers in the research group. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of participants to one of the group diets will be performed by one of the researchers in the research group using a randomization 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 (saturated fat) is not higher than group B (n-6 PUFA). Dietary fat manipulation (saturated vs n-6PUFA) increases plasma total cholesterol by 15% (0.64 mmol/L) within 8 days [1]. Therefore, assuming SD=0.76 mmol/L, 22 subjects per group will provide 80% power to demonstrate that group A does not have higher total cholesterol (i.e non-inferior) than group B (a= 0.05). Allowing for 15% dropouts, n=51.
[1] Bergeron N. and Havel R.J. Arteriosclerosis, Thrombosis, and Vascular Biology, 1995. 15: p. 2111-2121.

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8648 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 289866 0
Self funded/Unfunded
Name [1] 289866 0
Professor Manohar Garg 
Address [1] 289866 0
Room 305C, Medical Sciences Building
The University of Newcastle
University Drive
Callaghan NSW 2308 
Country [1] 289866 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 288713 0
None
Name [1] 288713 0
Address [1] 288713 0
Country [1] 288713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302685 0
University of Newcastle Research Ethics Committee
Ethics committee address [1] 302685 0
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 302685 0
Australia
Date submitted for ethics approval [1] 302685 0
30/04/2012
Approval date [1] 302685 0
29/05/2012
Ethics approval number [1] 302685 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 omega-3 fatty acids (n-3PUFA). If the same is true for humans, this research will have important implications for the prevention of cardiovascular disease and other chronic diseases. Therefore we hypothesize that saturated fat consumption does not raise blood lipid levels if the diet is sufficient in n-3PUFA. We also hypothesize that the benefits of n-3PUFA can be optimized when consumed in combination with saturated fats. This is a randomized controlled, dietary intervention trial, in parallel design with healthy adults. Subjects will be asked to consume 4x1g fish oil capsules (2.4g EPA:DHA 100:500) daily for 4 weeks, then they will be randomly assigned to one of two diets, a high saturated fat (SFA) diet or a high omega-6 fatty acid (n-6PUFA) diet both combined with n-3PUFA (fish oil), which they will consume for 10 days. Subjects on the SFA diet will consume daily 24g butter (which can be spread on bread, muffins or crackers), 40g white chocolate and 4x1g fish oil capsules, they will also be advised on how to use more foods containing saturated fat for cooking and reduce n-6PUFA containing oils. Subjects on the n-6PUFA diet will consume 20g margarine (which can be spread on bread, muffins or crackers), 42g sunflower seeds and 4x1g fish oil capsules, they will also be advised on how to use more foods and oils containing n-6PUFA for cooking, and reduce saturated fat. Participants will donate blood, give information on medical and supplement usage and physical activity and they will have their anthropometric measurements taken, at baseline, at 4 weeks and after 10 day of consuming either the SFA diet or the n-6PUFA diet. Subjects will also complete a 3 day food record.
Trial website
Trial related presentations / publications
DIAS, C.B.; AMIGO, N; WOOD, L.G.; MALLOL, R; CORREIG, X; GARG, M.L. Improvement of the omega 3 index of healthy subjects does not alter the effects of dietary saturated fats or n-6PUFA on LDL profiles (2017). Metabolism– Clinical and experimental, 68, 11-19. DOI: http://dx.doi.org/10.1016/j.metabol.2016.11.014

DIAS, C.B.; WOOD L.G.; GARG, M.L. Changes in blood lipid levels induced by different dietary fat types are not influenced by pre-supplementation with fish oil (2015). Proceedings of the Nutrition Society of Australia Annual Meeting, 39, 121.
Public notes

Contacts
Principal investigator
Name 51026 0
Prof Manohar Garg
Address 51026 0
School of Biomedical Sciences and Pharmacy, Medical Sciences Building, The University of Newcastle, University Drive, Callaghan NSW 2308
Country 51026 0
Australia
Phone 51026 0
+61 2 4921 5647
Fax 51026 0
+61 2 4921 2028
Email 51026 0
manohar.garg@newcastle.edu.au
Contact person for public queries
Name 51027 0
Mrs Cintia B. Dias
Address 51027 0
School of Biomedical Sciences and Pharmacy, Medical Sciences Building, The University of Newcastle, University Drive, Callaghan NSW 2308
Country 51027 0
Australia
Phone 51027 0
+61 2 4921 5638
Fax 51027 0
+61 2 4921 2028
Email 51027 0
cintia.dias@uon.edu.au
Contact person for scientific queries
Name 51028 0
Prof Manoha Garg
Address 51028 0
School of Biomedical Sciences and Pharmacy, Medical Sciences Building, The University of Newcastle, University Drive, Callaghan NSW 2308
Country 51028 0
Australia
Phone 51028 0
+61 2 4921 5647
Fax 51028 0
+61 2 4921 2028
Email 51028 0
manohar.garg@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical aproval was not obtained for sharing IPD.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary