Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000922774
Ethics application status
Approved
Date submitted
29/07/2013
Date registered
20/08/2013
Date last updated
14/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Postprandial effects of white meat versus red meat consumption on blood lipids.
Scientific title
Postprandial effects of white meat versus red meat consumption on blood lipids in healthy male and female subjects.
Secondary ID [1] 282915 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal metabolic development and function 289726 0
Condition category
Condition code
Diet and Nutrition 290055 290055 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 290237 290237 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an acute dietary intervention trial in healthy adults, in a cross over design. Participants will be asked to consume a standardised breakfast consisting of 2 slices of white toast, jam, fruit and tea/coffee with skim milk and asked to consume this breakfast at 7am on the test morning. Participants are then required to fast for 2 hours until they visit the University at 9am.

Participants will be randomised to consume one of the following foods:
Group A: Pork (200g of cooked pork mince)
Group B: Lamb (200g of cooked lamb mince)

All participants must consume the 200g serve within 10 minutes. Blood samples will be collected at baseline, 2, 4 and 6 hours following consumption of the test foods and will be analysed for plasma lipid profile (cholesterol, LDL & HDL-cholesterol and triglycerides). After a washout period of at least one week, subjects in Group A will consume lamb while those in Group B will consume pork and blood sampling will be repeated as above.
Intervention code [1] 287609 0
Prevention
Comparator / control treatment
Active (cross-over study). There is no control group as each participant's fasting blood sample will act as the control and compared to blood samples collected following each of the treatment groups.
Control group
Active

Outcomes
Primary outcome [1] 290105 0
The aim of this project is to examine the effects of the food matrix of white and red meat (pork and lamb) in which the lipids are embedded. It is proposed that the postprandial lipemic response will be different between the meats.The primary outcome measured are the changes in lipids.
Timepoint [1] 290105 0
At each of the intervention sessions, blood will be collected and lipid levels (LDL, HDL, Triglycerides, total cholesterol) will be measured at baseline, 2, 4 and 6 hours after treatment.
Secondary outcome [1] 303962 0
NIL
Timepoint [1] 303962 0
NIL

Eligibility
Key inclusion criteria
Healthy male or female
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently on lipid lowering drugs (eg statins) or fish oil supplements.
Diagnosed with dyslipidemia, hypercholesterolemia, gastrointestinal/liver disease or any
other condition relating to malabsorption or metabolism of lipids.
Have a body mass index (BMI) >30
Are current smokers
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287692 0
Commercial sector/Industry
Name [1] 287692 0
Pork Cooperative Research Centre
Country [1] 287692 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pork Cooperative Research Centre
Address
Pork CRC Ltd
Level 1, Eastwick Building,
University of Adelaide, Roseworthy Campus
5118, South Australia
Country
Australia
Secondary sponsor category [1] 286425 0
University
Name [1] 286425 0
The University of Newcastle
Address [1] 286425 0
The University of Newcastle,
University Drive, Callaghan
2308, New South Wales
Country [1] 286425 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Fatty acids are a necessary key energy source in the body, however, when present in excess, can be detrimental. Increased fasting blood fat (lipid) levels have long been accepted as a risk marker for chronic diseases such as cardiovascular disease, metabolic syndrome, obesity
and diabetes, however, there is now increasing evidence which points to postprandial lipemia being a more accurate indicator of risk.
The rate in which fats from the foods we consume are digested, absorbed and appear in the bloodstream is dependent on various factors, including (but not limited to)
the quality and quantity of fat and the nature of the matrix in which fat is embedded in the food. Postprandial monitoring of lipids therefore can reveal the variable response to food intake not seen under fasting conditions. It is this variation which is referred to as the
Lipemic Load. Analysis of the Lipemic Load provides a simple and accurate means of predicting the ability
of a food in modulating blood lipid levels, and can be used as a tool to help consumers choose foods for optimal health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41686 0
Prof Manohar Garg
Address 41686 0
305C Medical Sciences Building
University Drive, The University of Newcastle,
Callaghan, New South Wales 2308
Country 41686 0
Australia
Phone 41686 0
+61 2 49215647
Fax 41686 0
Email 41686 0
[email protected]
Contact person for public queries
Name 41687 0
Prof Manohar Garg
Address 41687 0
305C Medical Sciences Building
University Drive,The University of Newcastle,
Callaghan, New South Wales 2308
Country 41687 0
Australia
Phone 41687 0
+61 2 49215647
Fax 41687 0
Email 41687 0
[email protected]
Contact person for scientific queries
Name 41688 0
Prof Manohar Garg
Address 41688 0
305C Medical Sciences Building
University Drive, The University of Newcastle,
Callaghan, New South Wales 2308
Country 41688 0
Australia
Phone 41688 0
+61 2 49215647
Fax 41688 0
Email 41688 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.