Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000430932
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
27/04/2011
Date last updated
27/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Morosil (red orange) extract reduce the risk factors of metabolic syndrome?
Scientific title
The effect of Morosil extract in combination with nutritional intervention on the risk factors of metabolic syndrome
Secondary ID [1] 259997 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of metabolic syndrome 265652 0
Condition category
Condition code
Diet and Nutrition 265784 265784 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 265837 265837 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Morosil extract capsule 250mg oral administration, twice per day before meals for three months. Bioactive substances present in this red orange juice extract include: Anthocyanins 0.8 – 0.9%, Flavonoids 2 – 2.2%, Hydroxycinnamic acid 0.8 – 1.0%, and Ascorbic acid 4.3 – 4.5%.
Nutritional intervention involving the dietary recommendation on the individual bases will be provided to both groups. Participants will receive the recommendations once a week in the teaching clinic of Victoria University, St Albans campus.
Intervention code [1] 264414 0
Prevention
Comparator / control treatment
Placebo capsule containing maltodextrin, 250mg oral administration, twice per day before meals for three months.
Control group
Placebo

Outcomes
Primary outcome [1] 266538 0
weight loss - this will be assessed through physical measurement of body weight.
Timepoint [1] 266538 0
pre- and post-intervention
Primary outcome [2] 266595 0
triglyceride reduction - blood analysis will be conducted.
Timepoint [2] 266595 0
pre- and post-intervention
Primary outcome [3] 266596 0
reduction in waist circumference - this will be assessed through physical measurement.
Timepoint [3] 266596 0
pre- and post-intervention
Secondary outcome [1] 273995 0
change in basal metobolic rate (BMR) - this will be assessed using metabolic cart.
Timepoint [1] 273995 0
pre- and post-intervention
Secondary outcome [2] 276080 0
change in body composition examination using DEXA.
Timepoint [2] 276080 0
pre- and post-intervention

Eligibility
Key inclusion criteria
Males and females aged 30-60 years with a BMI greater than 25 or a waist circumference > 94cm for males and >80cm for females.
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Liver, kidney and heart disease, pregnancy, type 1 and type 2 diabetes with insulin medication, cigarette smoking and the use of any medication for weight loss.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264885 0
University
Name [1] 264885 0
Victoria University
Country [1] 264885 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
McKechnie Street St Albans, PO BOX 14428 Melbourne, Victoria 8001
Country
Australia
Secondary sponsor category [1] 263986 0
Commercial sector/Industry
Name [1] 263986 0
AZPA
Address [1] 263986 0
48 Translink Drive, Keilor Park VIC 3042
Country [1] 263986 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266841 0
Victoira University Human Research Ethics Committee
Ethics committee address [1] 266841 0
Ethics committee country [1] 266841 0
Australia
Date submitted for ethics approval [1] 266841 0
Approval date [1] 266841 0
24/03/2011
Ethics approval number [1] 266841 0
HRETH 11/43

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

Contacts
Principal investigator
Name 32487 0
Address 32487 0
Country 32487 0
Phone 32487 0
Fax 32487 0
Email 32487 0
Contact person for public queries
Name 15734 0
Sue Mansour
Address 15734 0
School of Biomedical & Health Sciences
Victoria University
McKechnie Street
St Albans
PO Box 14428,
Melbourne VIC 8001
Country 15734 0
Australia
Phone 15734 0
+61 3 9919 2318
Fax 15734 0
+61 3 9919 2465
Email 15734 0
[email protected]
Contact person for scientific queries
Name 6662 0
Michael Mathai; Xiao Su
Address 6662 0
School of Biomedical & Health Sciences
Victoria University
McKechnie Street
St Albans
PO Box 14428,
Melbourne VIC 8001
Country 6662 0
Australia
Phone 6662 0
+61 3 9919 2211; +61 3 9919 2318
Fax 6662 0
+61 3 9919 2465
Email 6662 0
[email protected]; [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.