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Trial registered on ANZCTR


Registration number
ACTRN12609000092291
Ethics application status
Approved
Date submitted
15/12/2008
Date registered
10/02/2009
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The evaluation of Chinese therapeutic food for the treatment of dyslipidemia
Scientific title
In patients with dyslipidemia, is the selected Chinese therapeutic food (specifically an extrat combining Hawthorn fruit and Chinese kiwi fruit) better than placebo, for regulating abnormal blood lipid levels?
Secondary ID [1] 769 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 4132 0
Condition category
Condition code
Alternative and Complementary Medicine 4330 4330 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intake of the therapeutic food powder(specifically an extract of Hawthorn fruit and Chinese kiwi fruit), 20g daily, for one month
The extracting concentration: raw Hawthorn fruit and raw Chinese kiwi fruit: extract powder=5:1 (It means that one unit of the powder is extracted and concentrated from five units of the raw fruits)
Intervention code [1] 3843 0
Treatment: Other
Comparator / control treatment
Intake of placebo powder(made of wheat germ and food additives) with similar looking and taste of the therapeutic food, 20g daily, for one month
Control group
Placebo

Outcomes
Primary outcome [1] 5216 0
changes of the levels of blood lipids (TC, LDL, HDL, TG) comparing with the levels at baseline
Timepoint [1] 5216 0
at baseline, 4 and 8 weeks after intervention commencement
Secondary outcome [1] 8783 0
changes of participants' general well-being, comparing with baseline assessment. The questionnaires of 'Short form 36' and 'Chinese medicine diagnostic assessment' will be used.
Timepoint [1] 8783 0
at baseline, 2, 4 and 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
having lived in Australia for the past 10 years ;
diagnosed with dyslipidemia (moderate level), in which fasting serum LDL-C level within 100-160mg/dL or TG within 150-250mg/dL;
with blood pressure lower than 159/99mmHg
Minimum age
40 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
other major medical conditions (ie. established CVD, severe diabetes, thyroid dysfunction, hepatic or renal disorders) or pregnancy;
having been taking other supplements or medicine which may influence blood lipid levels in the past 3 months;
allergic to the extract of the therapeutic food or wheat germ;
asthma;
fluid retention or severe diarrhoea;
with Asian cultural background

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)
Subjects will be divided into two groups, randomly matched through their initial blood lipid levels and other baseline characteristics. A PhD student will be invited as the third party to label the treatment and placebo powder (both of them will be packed in similar-looking containers), and to assign those treatment or placebo powder (marked as A or B) to match the participants’ codes and groups in which they are assigned. Only the "third party"will know the information of labels and codes, and will be asked not to reveal relevant information to either researchers or participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random-numbers table from Randomization.com (Dallal, 2003)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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)
Recruitment postcode(s) [1] 1487 0
3000
Recruitment postcode(s) [2] 1484 0
3011
Recruitment postcode(s) [3] 1483 0
3021
Recruitment postcode(s) [4] 1485 0
3039
Recruitment postcode(s) [5] 1486 0
3040

Funding & Sponsors
Funding source category [1] 4300 0
University
Name [1] 4300 0
Victoria University
Address [1] 4300 0
Victoria University, PO Box 14428, Melbourne VIC 8001
Country [1] 4300 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Victoria University, PO Box 14428, Melbourne VIC 8001
Country
Australia
Secondary sponsor category [1] 3872 0
None
Name [1] 3872 0
Address [1] 3872 0
Country [1] 3872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6347 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 6347 0
Victoria University Human Research Ethics Committee,
Office for Research,
Victoria University,
PO Box 14428,
Melbourne, VIC 8001
Ethics committee country [1] 6347 0
Australia
Date submitted for ethics approval [1] 6347 0
Approval date [1] 6347 0
19/12/2008
Ethics approval number [1] 6347 0
HRETH 08/204

Summary
Brief summary
The study aim is to evaluate the efficacy of selected Chinese therapeutic food (an extract combining Hawthorn fruit and Chinese Kiwi fruit) for dyslipidemia treatment. It is the hypothesized that the therapeutic food may have a positive effect on the treatment of dyslipidemia, and that it may improve participants’ general well-being.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35041 0
Address 35041 0
Country 35041 0
Phone 35041 0
Fax 35041 0
Email 35041 0
Contact person for public queries
Name 12388 0
Dr Hong Xu
Address 12388 0
School of Biomedical and Health Sciences, Victoria University, PO Box 14428, VIC 8001
Country 12388 0
Australia
Phone 12388 0
+61399192765
Fax 12388 0
Email 12388 0
hong.xu@vu.edu.au
Contact person for scientific queries
Name 3316 0
Dr Hong Xu
Address 3316 0
School of Biomedical and Health Sciences, Victoria University, PO Box 14428, VIC 8001
Country 3316 0
Australia
Phone 3316 0
+61399192765
Fax 3316 0
Email 3316 0
hong.xu@vu.edu.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