Protocol summary

Summary
The main objective of this study was to determine the effect of Quercetin supplementation on plasma Resistin levels and gene expression in Peripheral blood mononuclear cells and metabolic risk factors in women with Polycystic ovary syndrome. This study is a Double-blind, placebo-controlled randomized clinical trial. Sample size for this study is 76 person base on the power of 90 percent. Ask patients be present in the hospital on certain day while 12 to14 hour fast. After explaining the purpose and methodology of the study and obtaining informed consent from patients, 10 Mililiter fasting venous blood samples are taken and then measure the height and weight of patients. Participants should not have endocrine and metabolic disease like Hypothyroidism and Hyperthyroidism, Diabetes Mellitus, Adrenal Hyperplasia, Cushing, Hyperprolactinemia, Ovarian tumor and do not eat any drug that Impact on our results for example Metformin and lowering blood fat and weight-loss drugs. Patients in the group taking the supplement quercetin, receive 1 Gram supplement after breakfast and lunch in the form of two tablets of 500 mg for 12weeks duration. Patients in the placebo group receive quercetin placebo for 12 weeks, with similar recommendations. At the beginning and end of the intervention, lipid levels, blood glucose, insulin, serum resistin concentrations and inflammatory factors such as Tumor necrosis factor alpha will be measured and the information will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082215536N4
Registration date: 2017-03-04, 1395/12/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-04, 1395/12/14
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
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Quercetin supplementation on plasma level of Resistin and its gene expression in Peripheral blood mononuclear cells and metabolic risk factors in women with Polycystic ovary syndrome.
Public title
Effect of Quercetin supplementation on women with Polycystic ovary syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people with Body Mass Index between 25 to 40; age range of 20 to 40 year; According to the Rotterdam conference have at least 2 of the 3 criteria listed index as the disease is consider; criteria include irregular periods clinical or biochemical Hyperandrogenism and existence of Polycystic ovary base on ultrasound; willingness to cooperate; lack of medication Metformin; Oral contraceptive pill; Antihypertensive drug; lowering blood fat; Anti-inflammatory; Weight-loss drugs. Exclusion criteria: suffering from endocrine and metabolic disease like Hypothyroidism and Hyperthyroidism; Cancer androgen manufacturer; Diabetes mellitus; Adrenal Hyperplasia; Cushing; Ovarian tumors; Hyperprolactinemia; Smoking; Pregnancy; Lactation; Menopause; allergic reaction to the supplement; withdrew the patient from the study cooperation
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
For randomization, Quad blocks (21 blocks) generate by Excel software and the process of getting patients into groups base on these blocks are set.

Secondary Ids

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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
City
Tehran
Postal code
Approval date
2017-01-02, 1395/10/13
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1378

Health conditions studied

1

Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome Stein-Leventhal syndrome

Primary outcomes

1

Description
Plasma Resistin
Timepoint
Before and after intervention
Method of measurement
Resitin ELISA Kit

Secondary outcomes

1

Description
C-reactive protein
Timepoint
Before and after intervention
Method of measurement
Serum levels of hs-CRP ELISA Kit

2

Description
Glucose
Timepoint
Before and after intervention
Method of measurement
Serum ELISA Kit

3

Description
Insulin
Timepoint
Before and after intervention
Method of measurement
Serum ELISA kit micro

4

Description
Testosterone
Timepoint
Before and after intervention
Method of measurement
Serum Elisa kit

5

Description
Progesterone
Timepoint
Before and after intervention
Method of measurement
serum Elisa kit

6

Description
Luteinizing hormone
Timepoint
Before and after intervention
Method of measurement
ELISA kit

7

Description
Follicle-stimulating hormone
Timepoint
Before and after intervention
Method of measurement
ELISA kit

8

Description
Sex Hormone Binding Globulin
Timepoint
Before and after intervention
Method of measurement
IRMA

9

Description
Systolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Pressure set

10

Description
Diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Pressure set

11

Description
Resistin level
Timepoint
Before and after intervention
Method of measurement
RT-PCR

12

Description
Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Serum total cholesterol concentration turbidometry

13

Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Serum triglyceride concentrations were enzymatically

14

Description
Low-density lipoprotein
Timepoint
Before and after intervention
Method of measurement
LDL-C levels

15

Description
High-density lipoprotein
Timepoint
Before and after intervention
Method of measurement
Serum HDL cholesterol concentration

Intervention groups

1

Description
Intervention group; receive Quercetin supplements 1 Gram daily for 12 weeks as the two tablets of 500 Milligram after 2 main meals (breakfast and lunch) and this supplement should not be taken on an empty stomach.
Category
Treatment - Drugs

2

Description
Placebo group: receive placebo Quercetin for 12 weeks daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Dr. Ashraf Moini
Street address
West 162nd Street, Resalat highway, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Sixth Floor-Central University, Qods St, Keshavarz Blvd, tehran
City
Tehran
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 of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoud Khorshidi
Position
MSc Student Nutrition
Other areas of specialty/work
Street address
School of nutritional sciences and dietetics, Tehran University of Medical Sciences, St-hojjat-dost, St-Naderi, St-Enghelab, tehran
City
Tehran
Postal code
Phone
+98 21 8897 4463
Fax
Email
khorshidi.2065@gmail.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
professor
Other areas of specialty/work
Street address
School of nutritional sciences and dietetics, Tehran University of Medical Sciences, St-hojjat-dost, St-Naderi St-Enghelab, 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
Masoud Khorshidi
Position
MSc student of nutrition
Other areas of specialty/work
Street address
School of nutritional sciences and dietetics,Tehran University of Medical Sciences, St-hojjat-dost, St-Naderi, St-Enghelab, tehran
City
Tehran
Postal code
Phone
00
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
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