This study is designed to determine the effect of grape seed extract on HDL-C, apolipoprotein a, apolipoprotein b, and paraoxonase and arylesterase activity in hyperlipimic patients. 70 hyperlipimic patients will be randomly allocated into case and control groups. Each group will be treated with grape seed extract as case or starch as control group at a dose of 200 mg for 2 months. All the abovementioned parameters will be measured before intervention and after 8 week intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902073812N2
Registration date:2010-12-04, 1389/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-04, 1389/09/13
Registrant information
Name
Amir Ghorbanihaghjo
Name of organization / entity
Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz 51664, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3234
Email address
ghorbani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug Applied Research Center
Expected recruitment start date
2010-04-09, 1389/01/20
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of grape seed extract on serum paraoxonase activity in different Paraoxonase Phenotypes
Public title
Effect of grape seed extract on serum paraoxonase activity in different Paraoxonase Phenotypes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
healthy adults with
TG> 150 mg / dl and T.chol> 200mg/dl and had to be willing to cooperate.
Exclusion Criteria:
1. Severe hyperlipidemia
2.Treatment by Hyperlipidemic drugs or other drugs (two months before)
3. Consumption of vegetarian diets
4. Alcoholism
5. Kidney or heart failure
6. Malignant disease
7. BMI> 30 kg/m2
8. Chronic liver disease (transaminase two times more than normal)
9. Diabetes
10. Smoking and Tobacco
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-08-08, 1389/05/17
Ethics committee reference number
5/4/3606
Health conditions studied
1
Description of health condition studied
hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
lipid profile changes in hyperlipidemic pathients
Timepoint
Before and 8 week after intervention
Method of measurement
Spectrophotometric method
Secondary outcomes
1
Description
Changes in the PON activity
Timepoint
Before and 8 week after intervention
Method of measurement
Spectrophotometric method
Intervention groups
1
Description
Administration of grape seed extract in cases groop and estimated paraoxonase activity before and 8 weeks after intervention
Category
Treatment - Drugs
2
Description
Administration of placebo in control group and estimated of paraoxonase activity before and 8 weeks after intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug Applied Research Center
Full name of responsible person
Dr Hasan Argani
Street address
Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science-Drug Applied Research Center
Full name of responsible person
Dr Hossein Babaei
Street address
Tabriz University of Medical Sciences-Drug Applied Research Center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Science-Drug Applied Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science-Drug Applied Research Center
Full name of responsible person
Dr Amir Ghorbanihaghjo
Position
Academic Member
Other areas of specialty/work
Street address
Tabriz University of Medical Science-Drug Applied Research Center
City
Tabriz
Postal code
00984113363234
Phone
+98 914 314 7238
Fax
Email
ghorbaniamir@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr Amir Ghorbanihaghjo
Position
Associate Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences,Tabriz,Iran
City
Tabriz
Postal code
51664
Phone
+98 41 1336 3234
Fax
Email
ghorbaniamir@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Amir Ghorbanihaghjo
Position
PHD
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
51664
Phone
+98 41 1336 3234
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)