Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000903381
Ethics application status
Approved
Date submitted
15/06/2017
Date registered
20/06/2017
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Differential effect of single saturated fat feeding interventional trial in on blood triglycerides in healthy individuals.
Scientific title
Differential effects of short, medium and long chain saturated fatty acids on cardiovascular disease risk factors in healthy adults,
Secondary ID [1] 291819 0
Nil
Universal Trial Number (UTN)
U1111-1197-6328
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 303060 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Short chain fatty acid (butter 40 gram ), medium chain fats (coconut 40 gram ) and long chain fats (lard 40 gram ). Test food will be delivered in the form of biscuits. Biscuits will be made using wholemeal flour, cornflour, icing sugar and 40 gram lard or coconut or butter. Different flavours like orange, lemon and vanilla will be used to prepare biscuits. Participants should consume 6 biscuits (40gram fats) within 15 minutes in front of study staff. Participants will stay in the research area for at least 6-7 hours. All participants will participate for consuming 3 test food with a week wash out period.
Intervention code [1] 297933 0
Prevention
Comparator / control treatment
We are comparing between three fatty acids: short chain fatty acid (butter), medium chain fatty acids (coconut oil) and long chain fatty acids (lard).
Control group
Active

Outcomes
Primary outcome [1] 301935 0
Objective: To compare the differential postprandial effect of short, medium and long chain saturated fats on triglyceride levels.
Primary outcome: Triglyceride
Blood (approximately 440 µL) will be collected from the subject's middle and ring finger in the non-dominant hand using capillary collection tubes before and after 2, 3, 4 and 6 hour of test food consumption. Blood samples will be assessed for blood lipid profiles (total cholesterol, high density lipoprotein cholesterol and triglycerides) using Cardio Check PA (PTS).
Timepoint [1] 301935 0
Baseline and after 2, 3, 4 and 6 hour of test food consumption.
Secondary outcome [1] 334296 0
Blood samples will be assessed for low density lipoprotein cholesterol (LDL-C) using Cardio Check PA (PTS).
Timepoint [1] 334296 0
Baseline and after 2, 3, 4 and 6 hour of test food consumption.
Secondary outcome [2] 334297 0
Blood samples will be assessed for high density lipoprotein cholesterol (HDL-C) using Cardio Check PA (PTS).
Timepoint [2] 334297 0
Baseline and after 2, 3, 4 and 6 hour of test food consumption.
Secondary outcome [3] 334298 0
Blood samples will be assessed for total cholesterol (TC) using Cardio Check PA (PTS).
Timepoint [3] 334298 0
Baseline and after 2, 3, 4 and 6 hour of test food consumption.

Eligibility
Key inclusion criteria
Aged 18-65 years, healthy males or females with Body mass index (BMI) between 18 and 25Kg/m2
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Have BMI >25 Kg/m2;
• Are pregnant or breast feeding;
• Take any lipid lowering drugs (eg. statins or supplements (e.g. fish oil), or non-steroidal anti-inflammatory drugs (NSAIDs), or anti-hypertensive drugs, or vasodilators, or antioxidants vitamins.
• Are dieting or have any eating disorders;
• Have sensitivity or intolerance to any of the food products or ingredients used in the study;
• Have history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD; or pulmonary disease
• Have history of diabetes, hypertension, triglycerides higher than 3.0 mmol/L; total cholesterol higher than 5.5 mmol/L;
• Have history of gastrointestinal disorder, gall bladder disease, or liver disease;
• Taking any dietary supplements that influence blood lipid profile or inflammation;
• Smoke;
• Vegetarian or vegans

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Based on the anticipated 30% difference in primary outcome, iAUC for postprandial triglyceride levels, at the 0.05 level of significance, 80% power, standard deviation of 114 in iAUC. and 10% dropout rate, n=15 subjects will be required for the cross over design.

The effect of test foods on blood lipids and glucose will be determined by using repeated measure ANOVA with post hoc comparisons (Tukey’s honestly significant difference). Baseline data will be used as covariates and changes from the baselines will be determined using paired t-test. Data will be presented as mean ± standard deviation (SD) or median and interquartile range (IQR) as appropriate, a p-value = 0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2017
Actual
Date of last participant enrolment
Anticipated
13/09/2017
Actual
Date of last data collection
Anticipated
13/09/2017
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296320 0
University
Name [1] 296320 0
University of Newcastle
Country [1] 296320 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 295727 0
None
Name [1] 295727 0
Address [1] 295727 0
Country [1] 295727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297551 0
University of Newcastle Human Research Ethics Committee,
Ethics committee address [1] 297551 0
Ethics committee country [1] 297551 0
Australia
Date submitted for ethics approval [1] 297551 0
06/12/2016
Approval date [1] 297551 0
23/03/2017
Ethics approval number [1] 297551 0
H-2016-0429

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

Contacts
Principal investigator
Name 74410 0
Prof Manohar Garg
Address 74410 0
Nutraceuticals Research Program
School of Biomedical Sciences & Pharmacy
Callaghan NSW 2308
University of Newcastle
Country 74410 0
Australia
Phone 74410 0
+61-2- 4921 5647
Fax 74410 0
+61-2-4921 2028
Email 74410 0
[email protected]
Contact person for public queries
Name 74411 0
Nisha Panth
Address 74411 0
Level 3, Medical Sciences Building
University Drive
Callaghan NSW 2308
University of NewCastle
Country 74411 0
Australia
Phone 74411 0
+61249215638
Fax 74411 0
+61-2-4921 2028
Email 74411 0
[email protected]
Contact person for scientific queries
Name 74412 0
Nisha Panth
Address 74412 0
Level 3, Medical Sciences Building
University Drive
Callaghan NSW 2308
University of Newcastle
Country 74412 0
Australia
Phone 74412 0
+61249215638
Fax 74412 0
+61-2-4921 2028
Email 74412 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
SourceTitleYear of PublicationDOI
EmbaseMedium-chain fatty acids lower postprandial lipemia: A randomized crossover trial.2020https://dx.doi.org/10.1016/j.clnu.2019.02.008
N.B. These documents automatically identified may not have been verified by the study sponsor.