Effect of supplementation of quercetin on inflammatory factor and adiponectin and
gene expression of its receptors in women’s PBMC with polycystic ovary
syndrome(PCOS)
According to investigations, seems to be the first in the world and Iran the Effect of supplementation of quercetin on inflammatory factor and adiponectin and gene expresion. This clinical trial is designed as a double blind. Individuals who wish to participate in the study,and donot problem with quercetin supplementation include in . Inclusion criteria:
BMI 25 to 40 - the age range of 20-40 years - according to the Rotterdam conference, at least two of the three criteria listed as having the disease. Features include menstrual irregularities, or clinical symptoms and the presence of polycystic ovaries on ultrasound – Hyperandrogenism.
donot use drugs; contraceptive drugs, antihypertensive drugs lower blood lipid and anti-inflammatory drug- and willing to cooperate. Exclusion criteria:
Endocrine and metabolic diseases such as hypothyroidism and hyperthyroidism, androgen producing cancer, diabetes mellitus, adrenal hyperplasia and Cushing, ovarian tumor and Hyperprolactinaemia - Smoking - Pregnancy - allergic reaction to supplements - Cancel patient to cooperate in the study. In this study, 84 women (pcos) and in two groups of 42 patients will be enrolled and quercetin supplementation or placebo for 3 months will receive. Groups receiving 1 g daily quercetin supplementation in the form of two tablets of 500 mg after 2 main meals (breakfast and lunch) .. Blood samples were taken before and after the intervention. Blood cells will be separated at the beginning and end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112515536N1
Registration date:2014-05-14, 1393/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-14, 1393/02/24
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sicences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supplementation of quercetin on inflammatory factor and adiponectin and
gene expression of its receptors in women’s PBMC with polycystic ovary
syndrome(PCOS)
Public title
The effect of quercetin on PCOS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: BMI 25 to 40 - the age range of 20-40 years - according to the Rotterdam conference, at least two of the three criteria listed as having the disease. Features include menstrual irregularities, or clinical symptoms and the presence of polycystic ovaries on ultrasound – Hyperandrogenism.
donot use drugs; contraceptive drugs, antihypertensive drugs lower blood lipid and anti-inflammatory drug- and willing to cooperate.
Exclusion criteria: Endocrine and metabolic diseases such as hypothyroidism and hyperthyroidism, androgen producing cancer, diabetes mellitus, adrenal hyperplasia and Cushing, ovarian tumor and Hyperprolactinaemia - Smoking - Pregnancy - allergic reaction to supplements - Cancel patient to cooperate in the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor-Central Tehran University-Qods St., Keshavarz Blvd-tehran
Serum total cholesterol concentration turbidometry mg / dl
17
Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Serum triglyceride concentrations were enzymatically mg / dl
18
Description
Low-density lipoprotein
Timepoint
Before and after intervention
Method of measurement
LDL-C levels
19
Description
High-density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Serum HDL cholesterol concentration
Intervention groups
1
Description
to the intervention group Quercetin supplements , 1 g daily for 12 weeks as the two tablets of 500 mg after 2 main meals (breakfast and lunch)and should not be taken on an empty stomach.
Category
Treatment - Drugs
2
Description
Patients in the placebo group will receive 12 weeks of placebo quercetin
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr mohammad reza Hadian
Street address
International Campus-tehran university of medical science-porsina ave-ghods street-keshavarz blv-tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Neda Rezvan
Position
PhD Student Nutrition
Other areas of specialty/work
Street address
The fourth floor (Department of Nutrition and Biochemistry)-School of Public Health,Tehran Universit of Medical Sciences, Poursina St-Qods St-Enghelab St-tehran
City
Tehran
Postal code
Phone
+98 21 8897 4463
Fax
Email
neda.rezvan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Hosseinzadeh-Attar
Position
Assosiate professor
Other areas of specialty/work
Street address
Faculty of Health-Tehran University of Medical Sciences-Poursina St-ghods st-keshavarz blv-tehran
City
Tehran
Postal code
Phone
+98 21 8895 1395
Fax
Email
hosseinzadeh.mdphd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Neda Rezvan
Position
PhD student of Nutrition
Other areas of specialty/work
Street address
Fourth Floor-School of Public Health-Tehran University of Medical Sciences-Poursina st-Qods St-Enghelab St-tehran
City
Tehran
Postal code
Phone
+98 21 8897 4463
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)