Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000654853
Ethics application status
Approved
Date submitted
15/06/2012
Date registered
19/06/2012
Date last updated
13/12/2017
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
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 an acute study?
Secondary ID [1] 280681 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lipid levels and systemic inflammation 286709 0
Condition category
Condition code
Cardiovascular 287005 287005 0 0
Coronary heart disease
Diet and Nutrition 287011 287011 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 287024 287024 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A dietary intervention trial will be conducted in healthy subjects, in randomised controlled cross-over design. The trial will involve intervention with a single dose of dietary regimen followed by collection of 5 blood samples at 0, 3, 4, 5 and 6 hours following meal consumption. The meal will consist in 3 fish oil capsules (3 x 0.5g) and a portion (186g) of mashed potatoes containing 36g butter. Subjects will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken. In addition, subjects will complete a 24 hour food record. After a week period the participants will return and repeat the procedure for the alternative diet.
Intervention code [1] 285090 0
Treatment: Other
Intervention code [2] 285115 0
Prevention
Comparator / control treatment
A dietary intervention trial will be conducted in healthy subjects, in randomised controlled cross-over design. The trial will involve intervention with a single dose of dietary regimen followed by collection of 5 blood samples at 0, 3, 4, 5 and 6 hours following meal consumption. The meal will consist in 3 fish oil capsules (3x 0.5g) and a portion (180g) of mashed potatoes containing 30g of sunflower oil. Subjects will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken. In addition, subjects will complete a 24 hour food record. After a week period the participants will return and repeat the procedure for the alternative diet.
Control group
Active

Outcomes
Primary outcome [1] 287337 0
Incorporation of fatty acids into plasma
Timepoint [1] 287337 0
At both visits in each blood samples collected (0, 3, 4, 5 and 6 hours following meal consumption).
Primary outcome [2] 287338 0
Lipid profile (Trigycerides and total, LDL and HDL cholesterol)
Timepoint [2] 287338 0
At both visits in each blood samples collected (0, 3, 4, 5 and 6 hours following meal consumption).
.
Primary outcome [3] 287339 0
Analisys of inflammation markers (IL-6, TNF-alpha and hsCRP) in blood samples.
Timepoint [3] 287339 0
At both visits in each blood samples collected (0, 3, 4, 5 and 6 hours following meal consumption).
Secondary outcome [1] 297953 0
Nil
Timepoint [1] 297953 0
Nil

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
Are current using lipid-lowering drugs (eg statins) or fish oil supplements;
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 a smoker;
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 group diet 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 group diet will be performed by one of the researchers in the researsh group using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/07/2012
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
1/07/2013
Date of last data collection
Anticipated
Actual
31/07/2013
Sample size
Target
54
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285441 0
Self funded/Unfunded
Name [1] 285441 0
Professor Manohar Garg
Country [1] 285441 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 284292 0
None
Name [1] 284292 0
nil
Address [1] 284292 0
nil
Country [1] 284292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287455 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 287455 0
Researsh Office
The Chancellery of University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [1] 287455 0
Australia
Date submitted for ethics approval [1] 287455 0
Approval date [1] 287455 0
29/05/2012
Ethics approval number [1] 287455 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 low/deficient in omega-3 fatty acids. 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 randomized controlled trial in cross-over design. It involves intervention with a single dose of dietary regimen, after an overnight fast, followed by collection of 5 blood samples at 0, 3, 4, 5 and 6 hours following meal consumption. Participants will be randomised to one of two diets, high saturated fat or high omega-6 polyunsaturated fatty acids. They will be given a portion of mashed potatoes containing either butter (saturated fat) or vegetable oil (omega-6) and 3 capsules of fish oil. After a week period the participants will come back and repeat the procedure receiving the alternative diets. They will also be asked to fill a medical and physical activity questionnaire and a 24 hour food diary in each visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34318 0
Prof Manohar Garg
Address 34318 0
Medical Science Building, University of Newcastle, Callaghan, NSW 2308
Country 34318 0
Australia
Phone 34318 0
61-2-4921 5647
Fax 34318 0
Email 34318 0
[email protected]
Contact person for public queries
Name 17565 0
Dr Cintia Dias
Address 17565 0
School of Biomedical Sciences and Pharmacy
Medical Sciences Building
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 17565 0
Australia
Phone 17565 0
+61 2 4921 5638
Fax 17565 0
+61 2 4921 2028
Email 17565 0
[email protected]
Contact person for scientific queries
Name 8493 0
Prof Professor Manohar Garg
Address 8493 0
School of Biomedical Sciences and Pharmacy
Medical Sciences Building
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 8493 0
Australia
Phone 8493 0
+61 2 4921 5647
Fax 8493 0
+61 2 4921 2028
Email 8493 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
No additional documents have been identified.