Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000355572
Ethics application status
Approved
Date submitted
3/08/2006
Date registered
18/08/2006
Date last updated
18/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of barley foods on cardiovascular health biomarkers
Scientific title
A randomised cross-over study of the effects of barley foods containing beta-glucans compared with whole wheat foods on cardiovascular health biomarkers, total cholesterol, HDL cholesterol, LDL cholesterol & triglycerides in people with hypercholesterolaemia
Secondary ID [1] 295 0
Commonwealth Scientific Industrial Research Organisation (CSIRO): KR10A
Universal Trial Number (UTN)
Trial acronym
Barley
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolaemia 1325 0
Condition category
Condition code
Blood 1413 1413 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants at the start of the study will be on a fat controlled diet for 2 week prior to being randomised to 1 of 2 treatments of 6 weeks duration each & crossed over at the end of each 6 weeks to the alternative. The treatments are either test foods (cereal, bread muffins) containing either barley flour or wholemeal wheat flour. There is no wash-out period between treatments.
Intervention code [1] 1220 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1934 0
Fasting lipids
Timepoint [1] 1934 0
At weeks 2, 8 and 14
Secondary outcome [1] 3394 0
Glucose & insulin
Timepoint [1] 3394 0
At weeks 2, 8 & 14

Eligibility
Key inclusion criteria
Have a fasting plasma triglyceride concentration greater than 1.7mmol/L but less than 4.0 mmol/L, and/or plasma cholesterol greater than 5.5 mmol/L.Are taking cholesterol-lowering drugs provided the dose of medication remains stable for the duration of the study.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
:Have a definite or suspected personal or family history of adverse events or hypersensitivity to barley or wheat (eg. coeliac disease)Suffer from bleeding disordersAre considered by the doctor or dietitian to be unwilling, unlikely or unable to comprehend or comply with the study protocolHave participated in another research study within 30 days preceding the commencement of this studyHave a history or presence of gastrointestinal, renal or hepatic disease of any causeAre taking any medication or food that is likely to affect the plasma cholesterol such as laxatives containing psyllium, antibiotics, probiotics or sterol-containing margarines.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be randomly allocated by computer generated sequence to study treatments. The treatments are coded numerically. Locked computer files indicate treatment allocation numerically and the treatment code is concealed from research staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Volunteers will be initially blocked matched into 2 groups based on age, body mass index and gender, cholesterol level prior to randomisation by computer generated sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
2 week run-in followed by 12 week intervention
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/08/2006
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)

Funding & Sponsors
Funding source category [1] 1545 0
Government body
Name [1] 1545 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 1545 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
Address
Country
Australia
Secondary sponsor category [1] 1358 0
None
Name [1] 1358 0
Nil
Address [1] 1358 0
Country [1] 1358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2975 0
CSIRO Human Nutrition
Ethics committee address [1] 2975 0
Ethics committee country [1] 2975 0
Australia
Date submitted for ethics approval [1] 2975 0
Approval date [1] 2975 0
22/06/2006
Ethics approval number [1] 2975 0
06/13

Summary
Brief summary
To discover if the consumption of foods made from CSIRO barley leads to changes in the levels of substances in the plasma (such as cholesterol) that would suggest they are beneficial for heart health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35242 0
Address 35242 0
Country 35242 0
Phone 35242 0
Fax 35242 0
Email 35242 0
Contact person for public queries
Name 10409 0
Anne McGuffin
Address 10409 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10409 0
Australia
Phone 10409 0
+61 8 83038988
Fax 10409 0
+61 8 8303 8899
Email 10409 0
[email protected]
Contact person for scientific queries
Name 1337 0
Dr David Topping
Address 1337 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1337 0
Australia
Phone 1337 0
+61 8 83038930
Fax 1337 0
+61 8 8303 8899
Email 1337 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.