Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000069459
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
21/01/2016
Date last updated
19/02/2019
Date data sharing statement initially provided
19/02/2019
Date results provided
19/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Dietary Fat Structure on Blood Lipids in Healthy Australian Adults.
Scientific title
Effects of Positional Distribution of Fatty Acids within Triglycerides on Blood Lipid Profiles in Healthy Australian Adults.
Secondary ID [1] 288272 0
None
Universal Trial Number (UTN)
U1111-1178-2875
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular function 297223 0
Condition category
Condition code
Diet and Nutrition 297426 297426 0 0
Other diet and nutrition disorders
Cardiovascular 297427 297427 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three test fats, palm olein and cocoa butter (high in saturated fatty acids primarily in the sn-1 and sn-3 positions and unsaturated fatty acids primarily in the sn-2 position) and olive oil (high in unsaturated fatty acids primarily in the sn-2 position), will be compared using a 4-week single-blind, randomised 3x3 crossover feeding intervention, separated by 2-week washout periods and a 2-week run in phase, totalling 18 weeks.

For the entire 18 week period, participants will consume a background diet containing a daily average of 30% of total energy as fat, 15-25% as protein and 45-65% as carbohydrate. During the intervention periods, the test fats of interest will be consumed and account for 20% of the total fat intake. During the run in and washout phases, this 20% test fat will be replaced with premium palm oil (different composition to the test palm oil). All test fats will be supplied as pre-prepared frozen meals and baked biscuits.

Participants will attend the clinic at the beginning and end of each 4 week intervention and run-in phase (weeks 0, 2, 6, 8, 12, 14, 18). Dietary intake and test product consumption will be assessed by a simple checklist delivered via an online platform and cross checked by a dietitian at each participant clinic visit. Compliance will be further assessed from plasma fatty acid levels measured in the blood. Body weight, waist circumference, blood pressure and a fasted blood sample (20mL) will be collected at each clinic visit.
Intervention code [1] 293564 0
Prevention
Intervention code [2] 293565 0
Lifestyle
Comparator / control treatment
olive oil - unsaturated fat control
Control group
Active

Outcomes
Primary outcome [1] 296985 0
Blood Lipid Profile: Total Cholesterol, LDL-C, HDL-C, TAG, TC:HDL-C ratio)
Timepoint [1] 296985 0
weeks 0, 2, 6, 8, 12, 14 and 18
Secondary outcome [1] 319806 0
Blood Pressure - automated blood pressure monitor
Timepoint [1] 319806 0
weeks 0, 2, 6, 8, 12, 14 and 18
Secondary outcome [2] 320066 0
Emerging Blood Lipid biomarker - LDL subfractions
Timepoint [2] 320066 0
weeks 0, 2, 6, 8, 12, 14 and 18
Secondary outcome [3] 320067 0
Emerging Blood Lipid biomarkers - apolipoprotein A (apoA), apolipoprotein B (apoB), apoA:apoB ratio
Timepoint [3] 320067 0
weeks 0, 2, 6, 8, 12, 14 and 18
Secondary outcome [4] 320068 0
Emerging Blood Lipid biomarker - Lipoprotein(a)
Timepoint [4] 320068 0
weeks 0, 2, 6, 8, 12, 14 and 18

Eligibility
Key inclusion criteria
Males and females aged 20-40 years; BMI 18.5 to less than or equal to 27.5 kg/m2; Understand study and agree to participate; Adhere closely to the prescribed food consumption as per the research protocol
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Abnormal liver function test (elevated alanine transaminase (ALT), aspartate transaminase (AST)), abnormal kidney function test (elevated plasma creatinine); History of chronic disease - type 2 diabetes, heart disease, cancer, atherosclerotic disease, hypertension, stomach ulcers, hypo- or hyper-thyroidism; drug abuse or alcoholism; History of pancreatic insufficiency or other conditions resulting in fat malabsorption - chronic pancreatitis, cystic fibrosis, coeliac disease, crohns disease, gastric bypass surgery, small bowel resection; abnormal thyroid function; History of smoking during 6 months prior to study; On lipid/blood pressure lowering medication; Blood pressure >140/90 mmHg; Hyperlipidemia (elevated blood lipids) (fasting total cholesterol > 6.2 mmol/L, triglycerides > 2.0 mmol/L); Extended absences due to travel or other commitments; Known allergy to the test foods; Pregnancy or breastfeeding; Nutritional supplements that may affect the study outcomes; On any weight-loss programs; Females who are on hormone based contraceptives unless stable for at least 3 months prior to study commencement (no changes in type and dose) and have no intention to change during study.

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 allocation schedule will be determined by a staff member not involved in entering participants into the trial. The schedule will remain concealed from those staff members until after study ID assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin square, block randomisation by computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
58 participants will be recruited. Power calculations indicate that 48 participants will provide sufficient power (80% two tailed P=0.05) to detect a change of 0.6 mmol/L (associated with a 20% reduction in ischaemic heart disease mortality) in TC:HDL-C between interventions, allowing sufficient power to remain if 10 participants were to withdraw from the study).
Data will be analysed using a mixed linear model with computer statistical software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2016
Actual
11/01/2016
Date of last participant enrolment
Anticipated
2/05/2016
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
31/10/2016
Sample size
Target
58
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 12508 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 292656 0
Commercial sector/Industry
Name [1] 292656 0
Malaysian Palm Oil Board
Country [1] 292656 0
Malaysia
Primary sponsor type
Government body
Name
CSIRO Food and Nutrition
Address
PO Box 10041
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 291374 0
None
Name [1] 291374 0
none
Address [1] 291374 0
none
Country [1] 291374 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294129 0
CSIRO Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 294129 0
Ethics committee country [1] 294129 0
Australia
Date submitted for ethics approval [1] 294129 0
17/11/2015
Approval date [1] 294129 0
08/01/2016
Ethics approval number [1] 294129 0
HREC 15-2015

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

Contacts
Principal investigator
Name 54870 0
Dr Welma Stonehouse
Address 54870 0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Country 54870 0
Australia
Phone 54870 0
+61 8 8303 8919
Fax 54870 0
Email 54870 0
[email protected]
Contact person for public queries
Name 54871 0
Bianca Benassi-Evans
Address 54871 0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Country 54871 0
Australia
Phone 54871 0
+61 8 83038982
Fax 54871 0
Email 54871 0
[email protected]
Contact person for scientific queries
Name 54872 0
Welma Stonehouse
Address 54872 0
CSIRO Food and Nutrition
PO Box 10041
Adelaide SA 5000
Country 54872 0
Australia
Phone 54872 0
+61 8 8303 8919
Fax 54872 0
Email 54872 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
Not available for this study


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.