1. Home
  2. Approved trials
  3. » فارسی

Effect of supplementation with red grape seed extract on antioxidant status, lipid peroxidation and serum lipid profile in patient with type ΙΙ diabetes

Protocol summary

Summary
The aim of this study is to determine the effect of grape seed extract supplementation on biochemical and Redox indices in patients with type 2 diabetes. Fifty seven patients with type 2 diabetes who met the inclusion criteria were included in the study. These patients were recruited from Imam Reza endocrine clinic of Tabriz University of Medical Sciences, Iran. The patients were randomly assigned (22=placebo and 27=grape seed extract), in a double blind fashion, to receive placebo or grape seed extract (200mg/day) for 8 weeks. Weight, height, and blood pressure were measured at the first and the end of study. Fasting venous blood samples were taken before and after the treatment for biochemistry and Redox indices, including: fasting blood sugar, lipid profiles, HbA1C, Serum malondialdehyde (MDA), Total antioxidant capacity (TAC), superoxide dismutase (SOD), glutation peroxidase (GPX), 3-day food intake 24h recalls were taken measured for all participant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201009133253N3
Registration date: 2010-09-14, 1389/06/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-14, 1389/06/23
Registrant information
Name
Parvin Dehghan
Name of organization / entity
Tabriz MedicalSience University
Country
Iran (Islamic Republic of)
Phone
+98 937 139 5660
Email address
bahrampg@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tabriz Drug Appling Research Center
Expected recruitment start date
2009-11-16, 1388/08/25
Expected recruitment end date
2010-03-17, 1388/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supplementation with red grape seed extract on antioxidant status, lipid peroxidation and serum lipid profile in patient with type ΙΙ diabetes
Public title
Effect of supplementation with red grape seed extract in patient with type ΙΙ diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having diabetes for at least five years, 30 to 65 years of age, voluntary consent for participation in the study, using drugs to control blood glucose and not using insulin Exclusion criteria: using antioxidant supplements in the previous three months, persons with gastric treatment, pregnant and lactating women, presence of hepatic or renal failure, hyper and hypothyroidism, celiac, diarrehea, recent surgery or acute infection, using anticoagulant drugs
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 57
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
Tabriz University of Medical Sciences
Street address
Golbad street, Tabriz
City
Tabriz
Postal code
Approval date
2009-10-28, 1388/08/06
Ethics committee reference number
5/4/5910

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
non-Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
antioxidant indices
Timepoint
8 weeks after intervention after
Method of measurement
Assessments of changes in TAC.SOD, GPX.MDA

2

Description
lipid profiles
Timepoint
8 weeks after intervention after
Method of measurement
laboratory

3

Description
FBS and HbA1C
Timepoint
8 weeks after intervention
Method of measurement
laboratory

Secondary outcomes

1

Description
Blood pressure
Timepoint
8 weeks after the supplementation
Method of measurement
Sphygmometer

2

Description
Body Mass Index
Timepoint
8 weeks after the supplementation
Method of measurement
Weight(Kg)/height(m2)

Intervention groups

1

Description
200mg/day of red grape seed extract for 8 weeks
Category
Treatment - Drugs

2

Description
Placebo with the same dose for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza endocrine clinic
Full name of responsible person
Street address
Golbad street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Drug Applied Reaearch Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr Babae Hossein
Street address
Drug Applied Reaearch Center, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Reaearch Center, Tabriz University of Medical Sciences
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
Health and Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghassem
Position
PhD
Other areas of specialty/work
Street address
Health and Nutrition Faculty of Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
+98 41 1334 0634
Email
pourghassemb@tbzmed.ac.ir & bahrampg@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghassem
Position
PhD
Other areas of specialty/work
Street address
Golbad street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pourghassemb@tbzmed.ac.ir & bahrampg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health and Nutrition Faculty
Full name of responsible person
Abedini Somayeh
Position
MS
Other areas of specialty/work
Street address
Health and Nutrition Faculty of Tabriz
City
tabriz
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...