Effect of green tea tablet on inflammatory markers C-reactive protein, interleukin-6, tumor necrosis factor alpha, insulin, fasting blood glucose and blood lipid profile in women with polycystic ovary syndrome.
Green tea contains polyphenols such as catechin that have protective effects against a wide range of diseases associated with chronic inflammation. Given that chronic low-grade inflammation is associated with polycystic ovary syndrome and the inflammatory condition can eventually lead to heart disease, so it is important to consume some foods that could be effective on reduction of inflammation in these patients. This study was designed to investigate the effect of green tea tablets intake on inflammatory factors and lipid profile and blood sugar levels in patients with polycystic ovary syndrome. Inclusion criteria are Patients with this syndrome with age range 55-18 years, BMI 40-25 range and the key exclusion criteria is having other diseases.sample size is 50 that will be divided into two groups (green tea tablets and placebo groups). The period of intervention is 45 days. The primary outcomes are fasting blood glucose, lipid profile (LDL-C, TG, HDL-C and total cholesterol), and inflammatory factors hs-CRP, IL-6 and TNF-α.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021816123N4
Registration date:2015-03-11, 1393/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-11, 1393/12/20
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-03-08, 1393/12/17
Expected recruitment end date
2015-07-08, 1394/04/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green tea tablet on inflammatory markers C-reactive protein, interleukin-6, tumor necrosis factor alpha, insulin, fasting blood glucose and blood lipid profile in women with polycystic ovary syndrome.
Public title
The effect of green tea tablets in the treatment of polycystic ovary syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 55-18, 40-25 Body Mass Index, a willingness to participate in the study,having two features of the following three characteristics: oligo ovulation or anovulation, clinical or biochemical evidence of hyperandrogenism,having more than 12 but less than 10 mm immature follicles in each ovary. Exclusion criteria: no appropriate corporation; any other disease, pregnancy and lactating
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Scineces
Street address
The Ethics Committee, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2015-01-17, 1393/10/27
Ethics committee reference number
ajums.rec.1393.406
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Stein-Leventhal syndrome
Primary outcomes
1
Description
fasting blood glucose
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
2
Description
Insulin level
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
3
Description
LDL
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
4
Description
HDL
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
5
Description
TG
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
6
Description
total Cholesterol
Timepoint
at the first and at the end of intervention period
Method of measurement
Autoanalyzer
7
Description
hs-CRP
Timepoint
at the first and at the end of intervention period
Method of measurement
Elisa
8
Description
IL-6
Timepoint
at the first and at the end of intervention period
Method of measurement
Elisa
9
Description
TNF-α
Timepoint
at the first and at the end of intervention period
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: diet controlling;tablets containing 50 mg of green tea polyphenols 4 per day for 45 days.
Category
Treatment - Other
2
Description
Control:diet controlling for 45 days .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecologist's office
Full name of responsible person
Doctor P. Padfar
Street address
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Ahvaz Jundishapur 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition and Metabolic Disease Research Center, Ahvaz Jundishapur University of Medical Sciences, A
Full name of responsible person
Dr. Sima Jafarirad
Position
PhD
Other areas of specialty/work
Street address
Nutrition and Metabolic Disease Research Center, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 3373 8317
Fax
Email
jafarirad-s@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, paramedics schools
Full name of responsible person
Esmat mombeni
Position
Master Student of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Blvd, paramedics schools
City
Ahvaz
Postal code
Phone
00
Fax
Email
parand.m66@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)