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Trial registered on ANZCTR


Registration number
ACTRN12609000240246
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
11/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
2009 Cheese & Sterols Study. A 15 week randomised study investigating the effects of phytosterol-rich cheese products on cardiovascular markers on people with hypercholesterolaemia.
Scientific title
A 15 week randomised study investigating the effects of phytosterol-rich cheese products on cardiovascular markers on people with hypercholesterolaemia.
Universal Trial Number (UTN)
Trial acronym
KS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypercholesterolemia 4306 0
Condition category
Condition code
Diet and Nutrition 4540 4540 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to 1 of 4 treatments of 3 week duration each and crossed over at the end of each 3 weeks to the alternative treatment (for all 4 treatments). Each intervention will be double blind. After each 3 week phase a 1 week washout period, where volunteers return to their regular dietary intake is followed. The test foods are either cream cheese or cheese slices as follows:
1. 1 mini-tub of 40gm cream cheese containing 2.0gm sterol esters each day,
2. 2 serves of 20.5gm cheese slice containing 2.0gm sterol esters each day,
3. 1 mini-tub of 40gm sterol free cream cheese each day,
4. 2 serves of 20.5gm sterol free cheese slice each day. The test foods are reduced in total fat and volunteers will be required to incorporate the test foods into their existing diet by replacing like foods. This is in anticipation of maintaining energy balance to support weight maintenance throughout the study.
Intervention code [1] 4037 0
Lifestyle
Comparator / control treatment
Sterol free cream cheese and the sterol free cheese slice.
Control group
Active

Outcomes
Primary outcome [1] 5419 0
Lowering of Low Density Lipoprotein cholesterol by blood analysis
Timepoint [1] 5419 0
weeks 0,3,7,11 and 15
Secondary outcome [1] 9113 0
Carotenoid levels by blood analysis
Timepoint [1] 9113 0
weeks 0,3,7,11 and 15

Eligibility
Key inclusion criteria
Body Mass Index (BMI) less than 35.
Total cholesterol greater than 5.0mmol/L and less than 7.5mmol/L.
Triglycerides less than 4.5 mmol/L.
Participants currently taking phytosterol fortified products are permissible provided they have a 3 week washout prior to study commencement.
Minimum age
35 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
Participants taking any supplements (eg fish oil) and medications (eg statins/fibrates which could interfere with study parameters.
Presence of diabetes (as assessed from medical questionnaire fasting glucose great than 7mmol/L by fingerprick at screening)
Known lactose intolerance or dairy allergy.
Participation in a study within 30 days of commencement of the study.
Weight changes of more than 3kg over last 3 months.
History of Cardiovascular disease.

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)
Participants are screened for inclusion and exclusion criteria and once deemed eligible are randomly allocated into one of the 4 treatment orders. Allocation was concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using the computer software "Clinstat".
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

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

Funding & Sponsors
Funding source category [1] 4460 0
Commercial sector/Industry
Name [1] 4460 0
Kraft Foods
Address [1] 4460 0
162 Salmon St
Port Melbourne VIC 3207
Country [1] 4460 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Kraft Foods
Address
162 Salmon St
Port Melbourne VIC 3207
Country
Australia
Secondary sponsor category [1] 4019 0
Government body
Name [1] 4019 0
Commonwealth Scientific Industrial Research Organisation (CSIRO) Human Nutrition
Address [1] 4019 0
Gate 13 Kintore Ave
Adelaide SA 5000
Country [1] 4019 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6516 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 6516 0
Gate 13 Kintore Ave
Adelaide SA 5000
Ethics committee country [1] 6516 0
Australia
Date submitted for ethics approval [1] 6516 0
Approval date [1] 6516 0
12/12/2008
Ethics approval number [1] 6516 0
08/19

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

Contacts
Principal investigator
Name 29229 0
Address 29229 0
Country 29229 0
Phone 29229 0
Fax 29229 0
Email 29229 0
Contact person for public queries
Name 12476 0
Anne McGuffin
Address 12476 0
CSIRO Human Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Country 12476 0
Australia
Phone 12476 0
+61 8 83038988
Fax 12476 0
+61 8 8303 8899
Email 12476 0
anne.mcguffin@csiro.au
Contact person for scientific queries
Name 3404 0
Dr Peter Clifton
Address 3404 0
CSIRO Human Nutrition
Gate 13 Kintore Ave
Adelaide SA 5000
Country 3404 0
Australia
Phone 3404 0
+61 8 8303 8826
Fax 3404 0
+61 8 83038899
Email 3404 0
peter.clifton@csiro.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary