Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000795998
Ethics application status
Approved
Date submitted
28/07/2011
Date registered
28/07/2011
Date last updated
28/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of varying fat content milkshakes on subsequent fat metabolism
Scientific title
Effect of varied low dose oral fat loads on postprandial lipid metabolism in lean healthy males
Secondary ID [1] 262729 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 270438 0
Condition category
Condition code
Cardiovascular 270581 270581 0 0
Coronary heart disease
Diet and Nutrition 270582 270582 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cream based milkshake consumed in fasting state within 5 minutes, three lipid levels (varying amount of cream) crossover design. Washout period 2-3 weeks. Doses of lipid: i) 0.15 g/kg lean body mass, ii) 0.25 g/kg lean body mass, iii) 0.35 g/kg lean body mass
Intervention code [1] 267074 0
Lifestyle
Intervention code [2] 267075 0
Prevention
Comparator / control treatment
Each lipid level compared to each other (dose comparison)
Control group
Dose comparison

Outcomes
Primary outcome [1] 269325 0
Apolipoprotein B48 concentration in serum and lipoprotein fraction. Assayed using ELISA kit
Timepoint [1] 269325 0
0, 45, 90, 150, 240 minutes postprandially
Secondary outcome [1] 279379 0
Triglyceride concentration in serum and lipoprotein fraction. Assayed using automated analyser (colourimetric)
Timepoint [1] 279379 0
0, 45, 90, 150, 240 minutes postprandially

Eligibility
Key inclusion criteria
normotriglyceridaemic (TG<1.7 mM)
Healthy
Non-smoking
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hypertriglyceridaemic (TG>1.7 mM)
Diabetic
Smokers
Weight/diet fluctuations

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



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267546 0
University
Name [1] 267546 0
Curtin University
Country [1] 267546 0
Australia
Primary sponsor type
Individual
Name
Dr Anthony James
Address
School of Public Health
Curtin Univeristy
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 266584 0
None
Name [1] 266584 0
Address [1] 266584 0
Country [1] 266584 0
Other collaborator category [1] 252143 0
Individual
Name [1] 252143 0
Prof John Mamo
Address [1] 252143 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country [1] 252143 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269507 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 269507 0
Office of Research & Development
Curtin University
GPO Box U1987
Perth WA 6845
Ethics committee country [1] 269507 0
Australia
Date submitted for ethics approval [1] 269507 0
Approval date [1] 269507 0
19/05/2008
Ethics approval number [1] 269507 0
HR 95/2007

Summary
Brief summary
Does consumption of low doses of fat prevent subsequent rises in circulating lipid levels?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32945 0
Address 32945 0
Country 32945 0
Phone 32945 0
Fax 32945 0
Email 32945 0
Contact person for public queries
Name 16192 0
Dr Anthony James
Address 16192 0
School of Public Health
Curtin Univeristy
GPO Box U1987
Perth WA 6845
Country 16192 0
Australia
Phone 16192 0
+61 8 92662962
Fax 16192 0
Email 16192 0
T.P.James@curtin.edu.au
Contact person for scientific queries
Name 7120 0
Dr Anthony James
Address 7120 0
School of Public Health
Curtin Univeristy
GPO Box U1987
Perth WA 6845
Country 7120 0
Australia
Phone 7120 0
+61 8 92662962
Fax 7120 0
Email 7120 0
T.P.James@curtin.edu.au

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.