The effects of Grape Seed Extract supplementation on insulin resistance , the serum biochemical markers, adiponectin and resistin in adolescents with metabolic syndrome
The aim of this study is to determine effects of grape seed extract supplementation on insulin resistance , the serum biochemical markers, adiponectin and resistin in adolescents with metabolic syndrome. In this randomized double-blind study ,44 adolescents (13-19 years old ) with metabolic syndrome who do not use anti-inflammatory and antioxidant supplements and have no cardiovascular disease or any other interfering diseases, will be randomly allocated in supplement or placebo groups. The supplement group will receive 100 mg of grape seed extract capsules and the placebo group receive placebo capsules in a daily manner for 8 weeks. Demographic, 24-h food recall and international physical activity questionnaires will be completed for the subjects . At baseline, for all adolescents, nutritional and physical activity advice will be presented and they will be asked to follow the advice during the study. Anthropocentric ( weight, height and waist circumference ) and biochemical measurements ( lipid profile, fasting blood glucose , insulin , adiponectin and resistin ) as well as blood pressure determination will be at the beginning and also after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112611288N7
Registration date:2016-02-04, 1394/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-04, 1394/11/15
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition Research Center, Tabriz University of Medical
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Grape Seed Extract supplementation on insulin resistance , the serum biochemical markers, adiponectin and resistin in adolescents with metabolic syndrome
Public title
The effects of Grape Seed Extract in adolescents with Metabolic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adolescents aged 13-19 years;waist circumference (WC) above the 90th percentile in adolescents under 16 years old and WC more than 95 centimeter in adolescents over 16 years old plus 2 or more of the following items; HDL<40 mg/dL ( In teenage girls over 16 years old:HDL<50 mg/dL ) ; TG ≥ 150mg/dL; Fasting blood glucose ≥ 100 mg/dL; Systolic blood pressure ≥ 130 mmHg; Diastolic blood pressure ≥ 85mmHg
Exclusion criteria: Suffering from heart disease ; Kidney disease ; Liver disease ; Hyperthyroidism or hypothyroidism; The use of anti-inflammatory drugs; smoking; Triglycerides above 500 mg per deciliter; Pregnancy in teenage girls
; The use of antioxidant supplements in the past three months; The use anticoagulant drugs , including aspirin , warfarin; Sensitivity to grapes
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nutrition,Tabriz University of Medical Sciences,Tabriz
Street address
Daneshgah Street,Tabriz University of Medical Sciences Tabriz
City
Tabriz
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
TBZMED.REC.1394.771
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
R73.9
ICD-10 code description
Hyperglycaemia, unspecified
Primary outcomes
1
Description
Lipid profile (LDL, HDL, TG)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Enzymatic methods and Friedewald formula
2
Description
Fasting Blood Glucose
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Measurement of fasting blood glucose by using kits
3
Description
HbA1c
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Using ion exchange chromatography
4
Description
Fasting Plasma Insulin
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Elisa
5
Description
Anthropometric Indices (weight , height, waist circumference , BMI)
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Using stadiometer, scale and tape
6
Description
Blood Pressure
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
1
Description
Adiponectin
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Elisa kits
2
Description
Resistin
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Elisa kits
Intervention groups
1
Description
Intervention group : Grape Seed Extract capsules 100 mg once daily for 8 weeks
Category
Treatment - Drugs
2
Description
daily supplementation with placebo capsules for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykholrais Clinic
Full name of responsible person
Dr.Mohammad Alizadeh
Street address
Sheykholrais Clinic , Golbad Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Research Center,Tabriz University of Medical
Full name of responsible person
Dr. AliReza Ostad Rahimi
Street address
Facualty of Nutrition, Attar Street ,Golbad Street ,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center,Tabriz University of Medical
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Facualty of Nutrition,Tabriz University of Medical Sciences,Tabriz
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Ph.D. in Nutrition
Other areas of specialty/work
Street address
Daneshgah Street,Tabriz University of Medical Sciences Tabriz
City
Tabriz
Postal code
Phone
+98 41
Fax
Email
mdalizadeh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)