Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000458033
Ethics application status
Approved
Date submitted
28/05/2010
Date registered
4/06/2010
Date last updated
4/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Grape skin extract versus placebo in patients with metabolic syndrome and insulin resistance. A double blind, randomized, multicenter study.
Scientific title
In adults with metabolic syndrome, is grape skin extract combined with diet/exercise orientation effective in insulin resistance (measured using the homeostasis model assessment of insulin resistance [HOMA-IR] index), as compared to placebo plus diet/exercise orientation?
Secondary ID [1] 251890 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome 257481 0
Condition category
Condition code
Metabolic and Endocrine 257633 257633 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two arms:
1)grape skin extract 500 micrograms, three times a day, for 24 weeks; tablet
2)placebo (microcellulose) 500 micrograms, three times a day, for 24 weeks; tablet

Both arms will have non-pharmacological treatment (specialised diet taken daily for 24 weeks/exercise orientation: regular light/moderate-intensity physical activity at least 30 minutes daily, 4-7 days/week) according to the First Brazilian Guideline on the Diagnosis and Treatment of The metabolic Syndrome- Brazilian Society of Cardiology
Intervention code [1] 256579 0
Treatment: Drugs
Comparator / control treatment
placebo (microcellulose).
Control group
Placebo

Outcomes
Primary outcome [1] 258543 0
insulin resistance measured by the homeostasis model assessment of insulin resistance [HOMA-IR] index
Timepoint [1] 258543 0
all visits
Secondary outcome [1] 264386 0
blood pressure (using a calibrated sphygmomanometer)
Timepoint [1] 264386 0
all visits
Secondary outcome [2] 264387 0
lipids: high-density lipoprotein [HDL-c], low-density lipoprotein [LDL-c], total cholesterol, triglycerides (blood analysis)
Timepoint [2] 264387 0
all visits

Eligibility
Key inclusion criteria
diagnosis of metabolic syndrome
homeostasis model assessment of insulin resistance [HOMA-IR] >2,7
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hypertension (stages 2 and 3)
diabetes

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



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment outside Australia
Country [1] 2674 0
Brazil
State/province [1] 2674 0

Funding & Sponsors
Funding source category [1] 257075 0
Commercial sector/Industry
Name [1] 257075 0
Ache Laboratories
Country [1] 257075 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Ache Laboratories
Address
Rodovia Dutra km 222,2 Guarulhos, State of Sao Paulo Brazil CEP (ZIP) 07034-904
Country
Brazil
Secondary sponsor category [1] 256333 0
None
Name [1] 256333 0
N/A
Address [1] 256333 0
N/A
Country [1] 256333 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
In adults with metabolic syndrome the study will compare the efficacy of a grape skin extract combined with non-pharmacological treatment (diet/exercise orientation) in insulin resistance (measured using the homeostasis model assessment of insulin resistance [HOMA-IR] index), as compared to placebo plus non-pharmacological treatment (diet/exercise orientation). The hypothesis will consider the superiority of the grape skin extract therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31238 0
Address 31238 0
Country 31238 0
Phone 31238 0
Fax 31238 0
Email 31238 0
Contact person for public queries
Name 14485 0
Fabio Ikedo
Address 14485 0
Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
Country 14485 0
Brazil
Phone 14485 0
55-11-26088181
Fax 14485 0
Email 14485 0
[email protected]
Contact person for scientific queries
Name 5413 0
Fabio Ikedo
Address 5413 0
Rodovia Dutra km 222,2
CEP 07034-904
Guarulhos
Sao Paulo
Brazil
Country 5413 0
Brazil
Phone 5413 0
55-11-26088181
Fax 5413 0
Email 5413 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.