Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000201279
Ethics application status
Approved
Date submitted
22/01/2018
Date registered
7/02/2018
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of dietary fat structure on fat deposition in healthy Australian adults
Scientific title
Effect of positional distribution of fatty acids at the triglyceride backbone of dietary vegetable fats on fat deposition and selected health outcome measures in healthy Australian men and women
Secondary ID [1] 293849 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardio-metabolic disease 306309 0
Non-alcoholic Fatty Liver Disease (NAFLD) 306310 0
Obesity 306311 0
Cardiovascular disease 306312 0
Condition category
Condition code
Diet and Nutrition 305390 305390 0 0
Obesity
Metabolic and Endocrine 305391 305391 0 0
Diabetes
Cardiovascular 305392 305392 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 305393 305393 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Palm olein (POo), Cocoa butter (COB) and Soybean oil (SBO) (control) will be compared using a 16-week blinded, randomised, 3-arm parallel feeding study design preceded by a 2-week run-in period.
A highly controlled feeding protocol will be used - Participants will consume the same background diet (35%E fat, 18%E protein, 48%E carbohydrate) differing in test fats only. Test fats will provide 20%E as either POo, COB or SBO and will be delivered through meals and snacks. The run-in diet will be the same background diet as the intervention diet containing POo as major fat type.
The prescribed diets will be eucaloric to maintain body weight stability. Whole diets will be designed at different levels of energy in increments of 1500 kJ for adjustment to individual energy requirements. Participant’s individual energy requirements will be determined using the Schofield equation based on age and gender. Participants will then be assigned the closest 1500 kJ bracket. Participants will be requested not to consume any other high-fat foods and to consume all food supplied. All test meals and snacks will be provided to participants for the duration of the study. The test fats will be delivered within one main meal per day (either lunch or dinner) and snacks consumed in-between meals (biscuits/cake). The remaining diet will consists of low-fat meals and snacks including breakfast cereal (supplied) and a low-fat meal prepared by participants themselves according to prescribed guidelines. Daily ‘low-fat snacks’ (non-study snacks) will be prescribed as part of the dietary pattern. These will be fruit, low-fat dairy or bread and cereal options, and participant will have some flexibility to swap their low-fat snack allowances for low-fat discretionary product/s from a prescribed list which includes alcoholic beverages.
Pre-intervention, participants will attend a dietetic consultation regarding the dietary intervention (~45 minutes).
Compliance will be monitored using an online checklist that participants complete weekly. If deviations from the dietary protocol is reported, participants will be contacted by the dietitian to determine possible reasons for the deviation and adjustments to the prescribed energy intake level will be made if required. Compliance will also be cross-monitored during a brief consultation with a dietitian at each visit (~10 min per 4 weeks over 16 weeks).
Intervention code [1] 300107 0
Treatment: Other
Intervention code [2] 300108 0
Lifestyle
Comparator / control treatment
Soybean oil
Control group
Active

Outcomes
Primary outcome [1] 304529 0
Liver fat content as measured by proton magnetic resonance spectroscopy (MRS)
Timepoint [1] 304529 0
Weeks 0 and 16
Secondary outcome [1] 342268 0
Liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) using a Beckman AU480 clinical analyser
Timepoint [1] 342268 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [2] 342269 0
Composite secondary outcome: Adipose tissue (visceral and sub-cutaneous) as measured by magnetic resonance imaging (MRI)
Timepoint [2] 342269 0
Weeks 0 and 16
Secondary outcome [3] 342270 0
Total body fat content as measured by bioelectrical impedance analysis (BIA)
Timepoint [3] 342270 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [4] 342271 0
Composite secondary outcome: Obesity indices (body mass index (BMI), waist circumference (WC), waist-hip ratio (WHR), visceral adiposity index (VAI) and body adiposity index (BAI)) calculated using anthropometric data (height, weight, waist- and hip circumference) and serum lipid data (triacylglycerol and HDL-C).
Timepoint [4] 342271 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [5] 342272 0
Serum lipid profile - total cholesterol (TC), high density lipoprotein cholesterol (HDLC), triacylglycerol (TAG), low density lipoprotein cholesterol (LDLC) using a Beckman AU480 clinical analyser
Timepoint [5] 342272 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [6] 342273 0
Emerging blood lipid biomarkers - apolipoprotein A1 (apoA1) and B (apoB) using immunoturbidimetric assays
Timepoint [6] 342273 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [7] 342274 0
Emerging blood lipid biomarker - lipoprotein (a) (LPa) using immunoturbidimetric assay
Timepoint [7] 342274 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [8] 342275 0
Emerging blood lipid biomarker - LDL sub-fractions using a Lipoprint testing system
Timepoint [8] 342275 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [9] 342276 0
Faecal fatty acids using GCMS
Timepoint [9] 342276 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [10] 342277 0
Serum leptin using ELISA test kits on a microplate reader
Timepoint [10] 342277 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [11] 342278 0
Plasma glucose using Beckman AU480 clinical analyser
Timepoint [11] 342278 0
Weeks 0, 4, 8, 12, 16
Secondary outcome [12] 342279 0
Blood pressure using an automated blood pressure monitor
Timepoint [12] 342279 0
Weeks 0, 4, 8, 12, 16

Eligibility
Key inclusion criteria
1. Healthy adults
2. BMI 18.5-27.5 kg/m2
3. Understand the study requirements and willing to adhere closely to prescribed food consumption as per the research protocol
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Self-reported history of any of the following chronic diseases - type 2 diabetes, hypertension, coronary heart disease, hyperlipidemia, liver disease, cancer (excluding skin cancer), haemochromatosis
2. Self-reported 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
3. On medication/nutraceuticals that may affect liver function, blood lipids, blood pressure or body weight, as assessed by the Principal Investigator or designee
4. Self-reported history of claustrophobia – to enable MRS/MRI assessments to be performed
5. Presence of any ferrous metal in the body - to enable MRS/MRI assessments to be performed.
6. Self-reported pregnant or currently lactating women
7. Females who are post-menopausal, on hormone replacement therapy or on hormone based contraceptives, unless they are stable for at least 3 months prior to study commencement (no changes in type and dose) and have no intention to change during study
8. History of smoking during the 6 months prior to the study
9. Alcohol consumption >21 units per week for men & >14 units per week for women
10. Mean blood pressure >140/90 mmHg assessed at screening visit
11. Hyperlipidemia (fasting TC>6.2 mmol/L or TAG >2.0 mmol/L) assessed at screening visit
12. Abnormal serum liver enzymes (ALT, AST) assessed at screening visit
13. Extended absences due to travel or other commitments
14. Self-reported known allergies to intervention foods
15. On any weight-loss program

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)
Randomisation of eligible participants will be conducted by a different person than the person who decides that a participant is eligible for inclusion in the trial. Hence the person who makes decision regarding eligibility will not be aware at the time and have no influence over which groups participant are allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be assigned to interventions using stratified random assignment based on gender. The randomisation scheme will be computer generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power for this study is based on the primary outcome; liver fat content. A sample size of 24 participants per group will provide 80% power at a=0.05 to detect a minimum difference of 1.5% in liver fat content between treatments. The calculation is based on an average SD of 1.8% observed within healthy lean Caucasian populations. Considering a dropout rate of ~20% a total sample of 90 participants (30/group) will be recruited. Main intervention effects will be assessed using mixed effects longitudinal models. Statistical analyses will be performed using IBM SPSS statistics for WINDOWS (Chicago, USA). All statistical tests will be performed with = level =0.05 (2-tailed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2018
Actual
30/04/2018
Date of last participant enrolment
Anticipated
3/08/2018
Actual
6/08/2018
Date of last data collection
Anticipated
14/12/2018
Actual
14/12/2018
Sample size
Target
90
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 18631 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298469 0
Commercial sector/Industry
Name [1] 298469 0
Malaysian Palm Oil Board
Country [1] 298469 0
Malaysia
Primary sponsor type
Government body
Name
CSIRO Health and Biosecurity
Address
PO Box 10041
Adelaide SA, 5000
Country
Australia
Secondary sponsor category [1] 297609 0
None
Name [1] 297609 0
Address [1] 297609 0
Country [1] 297609 0
Other collaborator category [1] 279908 0
University
Name [1] 279908 0
University of Sydney
Address [1] 279908 0
75 East Street Lidcombe, New South Wales, Australia, 2141
Country [1] 279908 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299458 0
CSIRO Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 299458 0
Ethics committee country [1] 299458 0
Australia
Date submitted for ethics approval [1] 299458 0
21/11/2017
Approval date [1] 299458 0
16/01/2018
Ethics approval number [1] 299458 0
11/2017

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

Contacts
Principal investigator
Name 80470 0
Dr Welma Stonehouse
Address 80470 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide, SA, 5000
Country 80470 0
Australia
Phone 80470 0
+61 8 8303 8919
Fax 80470 0
Email 80470 0
[email protected]
Contact person for public queries
Name 80471 0
Bianca Benassi-Evans
Address 80471 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide, SA, 5000
Country 80471 0
Australia
Phone 80471 0
+61 8 8303 8982
Fax 80471 0
Email 80471 0
[email protected]
Contact person for scientific queries
Name 80472 0
Welma Stonehouse
Address 80472 0
CSIRO Health and Biosecurity
PO Box 10041
Adelaide, SA, 5000
Country 80472 0
Australia
Phone 80472 0
+61 8 8303 8919
Fax 80472 0
Email 80472 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
Undecided


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
EmbaseEucaloric diets enriched in palm olein, cocoa butter, and soybean oil did not differentially affect liver fat concentration in healthy participants: A 16-week randomized controlled trial.2021https://dx.doi.org/10.1093/ajcn/nqaa347
N.B. These documents automatically identified may not have been verified by the study sponsor.