The purpose of this study is to investigate the effects of resveratrol supplement on metabolic factors in PCOS patients. 80 patients with PCOS (according to Androgen Excess Society criteria)and don’t have thyroid disease and androgenic hormone secretor tumors between the age range of 18-40 will be randomly assigned to groups that received either resveratrol or placebo (one time a day) for 12 weeks. FSH, LH, SHBG, fasting blood sugar, insulin, HDL, LDL-C, total cholesterol, triglycerides ,blood pressure, body composition will be measured before and 12 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061917139N2
Registration date:2017-07-17, 1396/04/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-17, 1396/04/26
Registrant information
Name
Mohammad Reza Mohajeri-tehrani
Name of organization / entity
Endocrinology and Metabolism Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0071
Email address
mrmohajeri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
EMRI & Alborz University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of resveratrol supplementation on hormonal, inflammatory and metabolic in women with PCOS.
Public title
The effect of resveratrol on PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PCOS diagnosis (according to Androgen Excess Society criteria); hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone >70ng/dl) and/or oligomenorrhea (<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound
Women aged from 18 to 40 years old; Normal prolactin; normal thyroid function; 17-OH progesterone; No evidence of Androgenic hormone secretor tumors; Cushing's syndrome or acromegaly
Exclusion criteria:
Use of either oral contraceptives, steroids hormones or other medications that could modify the metabolism 3 months before the onset of the trial.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Alborz University of Medical Sciences
Street address
Educational Department, Alborz University of Medical Sciences, North Taleqani Blvd, Taleqani Square, Karaj
City
Karaj
Postal code
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
Abzums.rec.1395.135
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovarian syndrome
Primary outcomes
1
Description
(S.H.B.G) Sex Hormon Binding Globolin
Timepoint
Before and 12 weekes after the intervention
Method of measurement
-
2
Description
FSH
Timepoint
Before and 6 weekes after the intervention
Method of measurement
ng/ml
3
Description
LH
Timepoint
Before and 6 weekes after the intervention
Method of measurement
ng/ml
4
Description
Fasting blood sugar
Timepoint
Before and 6 weekes after the intervention
Method of measurement
mg/dl
5
Description
testosterone
Timepoint
Before and 12 weekes after the intervention
Method of measurement
ng/ml
6
Description
DHEA-S
Timepoint
Before and 12 weekes after the intervention
Method of measurement
nmol/L
Secondary outcomes
1
Description
HDL- cholesterol
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mg/dl
2
Description
HOMA-insulin resistance
Timepoint
Before and 12 weekes after the intervention
Method of measurement
-
3
Description
Hs-CRP
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mg/dl
4
Description
c-peptide
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mg/dl
5
Description
LDL-Cholesterol
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mg/dl
6
Description
Creatinine
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mg/dl
7
Description
total serum cholesterol
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mg/dl
8
Description
TG
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mg/dl
9
Description
Body composition (FM,FFM)
Timepoint
Before and 12 weekes after the intervention
Method of measurement
%
10
Description
insulin levels
Timepoint
Before and 12 weekes after the intervention
Method of measurement
mU/ml
11
Description
HbA1C
Timepoint
Before and 12 weekes after the intervention
Method of measurement
%
12
Description
Weight
Timepoint
Before and 12 weekes after the intervention
Method of measurement
kg
Intervention groups
1
Description
Resveratrol(one time a day)
Category
Treatment - Drugs
2
Description
placebo(maltodextrin) one time a day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
EMRI
Full name of responsible person
Mohammad Reza Mohajeri-Tehrani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
EMRI
Full name of responsible person
Mostafa Qorbani
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
EMRI
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
2
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Mostafa Qorbani
Street address
Alborz University of Medical Sciences, North Taleqani Blvd, Taleqani Square, Karaj, Islamic Republic of Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
EMRI
Full name of responsible person
Mostafa Qorbani
Position
assistant professor
Other areas of specialty/work
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue, Tehran, 1411413137, Iran
City
Tehran
Postal code
Phone
+98 21 8822 0071
Fax
Email
mqorbani1379@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
EMRI
Full name of responsible person
Mohammad Reza Mohajeri-Tehrani
Position
MD
Other areas of specialty/work
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue, Tehran, 1411413137,Iran
City
Tehran
Postal code
Phone
+98 21 8822 0071
Fax
Email
mrmohajeri@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
EMRI
Full name of responsible person
Asieh Mansour
Position
PhD student
Other areas of specialty/work
Street address
Endocrinology & Metabolism Research Institute, 5th floor, Shariati Hospital, North Kargar Avenue, Tehran, 1411413137,Iran
City
Tehran
Postal code
Phone
00
Fax
Email
asiehmansour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)