Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001633471
Ethics application status
Approved
Date submitted
2/11/2016
Date registered
25/11/2016
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Date results provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Postprandial effect of high fat foods with different structures on plasma triglyceride levels in healthy adults
Scientific title
Postprandial effect of high fat foods with different structures on plasma triglyceride levels in healthy adults
Secondary ID [1] 290063 0
Nil
Universal Trial Number (UTN)
U1111-1187-0658
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidaemia 300122 0
High postprandial lipemia 300124 0
Condition category
Condition code
Cardiovascular 300001 300001 0 0
Coronary heart disease
Diet and Nutrition 300592 300592 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in this study will be asked to visit our clinical facilities either at the University of Newcastle (Callaghan campus, NSW, Australia) or at Massey University (Turitea campus, Manawatu, New Zealand), four times. At their first appointment they will go through a screening process. They will be asked to complete a brief medical questionnaire, a physical activity questionnaire, a food frequency questionnaire and an eating attitudes test. They will also have their blood tested using finger prick and have their anthropometric measurements (weight, height, body muscle mass, etc.) and blood pressure taken.
The day before their second appointment they will be asked to refrain from physical activity and alcohol consumption, to consume a low fat standard evening meal and fast overnight (10 hours). The low fat meal will be provided by the research team and will contain less than 15% fat.
In the morning of their second appointment they will have two blood samples collected (one using finger prick and one using single venepuncture) and will be asked to complete an appetite sensations questionnaire and a 24 hour food recall. The 24 hour food recall involves recording all the food and beverages consumed over the 24 hour period prior to their appointment. They will be given instructions on how to record this information on arrival. After that they will consume a high fat food product (biscuits, a flan or a beverage) designed by the research investigators to deliver 40g of fat and provide about 790 calories. They will then have six blood samples collected (30, 60, 120, 180, 240 and 360 minutes after meal consumption) using finger prick and will answer to an appetite sensations questionnaire every 2 hours. During this period they will remain at our clinical facilities (about 7 hours in total).
After a week period they will be asked to visit our clinical facilities again for their third appointment and repeat the procedure consuming a different food. At this appointment blood samples will be collected using only finger prick. After another week they will come to their forth appointment and repeat the procedure consuming a third food product.
They may also choose to participate in our internal validation group. This involves donating 2 extra blood samples collected using single venepuncture in one of your appointments.
Intervention code [1] 295784 0
Prevention
Intervention code [2] 295785 0
Lifestyle
Comparator / control treatment
This intervention involves active controls. Three food products containing similar nutrient composition and different structure (liquid, semi-solid and solid) designed to deliver 40g of fat will be used. The liquid product will be a beverage, the semi-solid will be a product with flan like consistency and the solid product will be biscuits.
Control group
Active

Outcomes
Primary outcome [1] 299491 0
Plasma triglyceride kinetics in response to the consumption of a food product.
Timepoint [1] 299491 0
Blood collection and measurements in the fasting state (baseline) and the postprandial state (30, 60, 120, 180, 240, 360 min post meal consumption).
Secondary outcome [1] 327320 0
Plasma glucose kinetics in response to the consumption of a food product.
Timepoint [1] 327320 0
Blood collection and measurements in the fasting state (baseline) and the postprandial state (30, 60, 120, 180, 240, 360 min post meal consumption).
Secondary outcome [2] 328804 0
Appetite sensations measured using visual analogue scales 100mm long with words at each side expressing the lowest and the highest rate. This scale will be used to measure hunger, satiety and desire to eat.
Reference:
Flint, A., et al., Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. International Journal of Obesity, 2000. 34: p. 38-48.
Timepoint [2] 328804 0
Data collected in the fasting state (baseline) and the postprandial state (2, 4 and 6 hours post meal consumption).
Secondary outcome [3] 329608 0
Plasma total cholesterol kinetics in response to the consumption of a food product.
Timepoint [3] 329608 0
Blood collection and measurements in the fasting state (baseline) and the postprandial state (30, 60, 120, 180, 240, 360 min post meal consumption).
Secondary outcome [4] 329609 0
Plasma high density lipoprotein cholesterol kinetics in response to the consumption of a food product.
Timepoint [4] 329609 0
Blood collection and measurements in the fasting state (baseline) and the postprandial state (30, 60, 120, 180, 240, 360 min post meal consumption).
Secondary outcome [5] 329610 0
Plasma low density lipoprotein cholesterol kinetics in response to the consumption of a food product.
Timepoint [5] 329610 0
Blood collection and measurements in the fasting state (baseline) and the postprandial state (30, 60, 120, 180, 240, 360 min post meal consumption).

Eligibility
Key inclusion criteria
Healthy males and females aged between 18 and 40 years old at initial assessment and with normal body weight (body mass index between 18 and 25 Kg/m2).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects are NOT eligible to participate if they:
Are currently taking any lipid lowering drugs or supplements (e.g. statins, fish oil) or anti-hypertensive drugs;
Are dieting or have any eating disorders;
Have allergy or intolerance to any of the food products or ingredients used (during the initial screening participants will be informed about the food product composition);
Have history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD;
Have history of diabetes, hypertension, triglycerides higher than 3 mmol/L or total cholesterol higher than 5 mmol/L;
Have history of gastrointestinal disorder or liver disease;
Exercise more than 30 minutes per day or 4 hours per week;
Smoke;
Are pregnant or breast feeding

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)
Central randomization using computer generated tables
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of participants to one of the meals will be performed using a randomization table created by computer software (www.randomization.com).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Postprandial
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Paired t-test was used for calculating sample size (Formula 1). The sample size calculation was based on an anticipated 130% (88.8) difference in incremental area under the curve (iAUC) between test meals for plasma triglycerides with level of significance 0.05 and 80% power. Using a standard deviation of 114.09 in iAUC (Berry et al, 2008), a minimum of 13 subjects would be required in each interventional treatment. Allowing for 10% dropouts and non-compliant subjects, and aiming for an equal number of males and females we will recruit n=30 (15 males and 15 females).

The incremental area under (iAUC) the post-prandial curve (hourly measurements) will be calculated, using the trapezoid rule, for the standard or reference meal and all the test meals. The lipemic load of a test meal will then be calculated based on the iAUC of the standard meal, as a percentage of the iAUC of the standard meal (OOi et al, 2011).
Curves for different test meals will also be compared using repeated measures Analyses of Variance to determine difference in peak triglyceride in plasma and return to fasted state. In addition, maximum postprandial concentration (peak concentration) and the time length for its appearance as well as the total change from fasting to peak concentration will be measured.

Reference
Berry, S.E.E., et al., Manipulation of lipid bioaccessibility of almond seeds influences postprandial lipemia in healthy human subjects. The American Journal of Clinical Nutrition, 2008. 88: p. 922–929.
Ooi, T.C., et al., Proposing a "Lipemic index" as a nutritional and research tool. Current Vascular Pharmacology, 2011. 9: p. 313-317.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2017
Actual
9/01/2017
Date of last participant enrolment
Anticipated
1/05/2017
Actual
14/08/2017
Date of last data collection
Anticipated
26/05/2017
Actual
5/09/2017
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 8170 0
New Zealand
State/province [1] 8170 0
Palmerston North/ Manawatu

Funding & Sponsors
Funding source category [1] 294428 0
Government body
Name [1] 294428 0
Centre of research excellence – Tertiary education (CoRE-TEC)
Country [1] 294428 0
New Zealand
Primary sponsor type
University
Name
Riddet institute, Massey university
Address
Massey University
Palmerston North, 4442
Country
New Zealand
Secondary sponsor category [1] 293281 0
University
Name [1] 293281 0
Nutraceuticals Research Program, University of Newcastle
Address [1] 293281 0
School of Biomedical Sciences and Pharmacy
University of Newcastle
University Drive, NSW2308
Country [1] 293281 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296213 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 296213 0
Ethics committee country [1] 296213 0
New Zealand
Date submitted for ethics approval [1] 296213 0
30/08/2016
Approval date [1] 296213 0
27/09/2016
Ethics approval number [1] 296213 0
SOA 16/54
Ethics committee name [2] 296242 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 296242 0
Ethics committee country [2] 296242 0
Australia
Date submitted for ethics approval [2] 296242 0
02/09/2016
Approval date [2] 296242 0
31/10/2016
Ethics approval number [2] 296242 0
H-2016-0315

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

Contacts
Principal investigator
Name 68726 0
Prof Manohar Garg
Address 68726 0
Nutraceuticals Research Program
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 68726 0
Australia
Phone 68726 0
+61-2-4921 5647
Fax 68726 0
+61-2-4921 2028
Email 68726 0
[email protected]
Contact person for public queries
Name 68727 0
Cintia B Dias
Address 68727 0
Riddet Institute, Private bag 11 222, Massey University, Palmerston North, 4442
Country 68727 0
New Zealand
Phone 68727 0
+64 06 9517759
Fax 68727 0
Email 68727 0
[email protected]
Contact person for scientific queries
Name 68728 0
Cintia B Dias
Address 68728 0
Riddet Institute
Private bag 11 222, Massey University, Palmerston North, 4442
Country 68728 0
New Zealand
Phone 68728 0
+64 06 9517759
Fax 68728 0
Email 68728 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
No ethical approval was obtained for sharing IPD.


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.