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Effect of grape seed extract (GSE) supplementation on serum levels of androgens, gonadotropins and high sensitivity c-reactive protein in women with polycystic ovary syndrome (PCOS)

Protocol summary

Study aim
Effect of grape seed extract (GSE) supplementation on serum levels of androgens, gonadotropins and high sensitivity c-reactive protein in women with polycystic ovary syndrome (PCOS)
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, 50 patients with polycystic ovary syndrome.
Settings and conduct
This clinical trial-double blind is conducted in Imam Khomeini Hospital, Ahvaz
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 25 years to pre-menopause, body mass index less than or equal to 30, diagnosis of PCOS according to the Rotterdam criteria and diagnosis of a gynecologist. Inclusion criteria: unwillingness of patients to participate in the study, suffering from kidney diseases, coronary arteries, acute and chronic pulmonary inflammation, short bowel syndrome, allergies, pregnancy and breastfeeding, traveling for more than 2 weeks, smokers, use of supplements Food and anti-inflammatory drugs, use of any antioxidant supplements in the last 3 months, use of immunosuppressive drugs, following special diets, changing diet or deciding to lose weight, taking hormonal drugs
Intervention groups
ذخیره کردن ترجمه The intervention group received a daily supplement of 250 mg of grape seed extract (GSE) for 8 weeks. The control group received a placebo daily for 8 weeks.
Main outcome variables
testosterone, prolactin, Luteinizing Hormone (LH),Follicle-Stimulating Hormone (FSH), Fasting insulin, fasting blood sugar

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220921056011N1
Registration date: 2022-10-20, 1401/07/28
Registration timing: prospective

Last update: 2022-10-20, 1401/07/28
Update count: 0
Registration date
2022-10-20, 1401/07/28
Registrant information
Name
marzie zilae
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 2713
Email address
marziezilae67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of grape seed extract (GSE) supplementation on serum levels of androgens, gonadotropins and high sensitivity c-reactive protein in women with polycystic ovary syndrome (PCOS)
Public title
Effect of grape seed extract (GSE) supplementation on serum levels of androgens, gonadotropins and high sensitivity c-reactive protein in women with polycystic ovary syndrome (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25 to pre-menopause BMI<=30 Diagnosis of PCOS based on the Rotterdam criteria and the diagnosis of a gynecologist
Exclusion criteria:
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The type of treatment is selected by numbering in the envelope. participates and researcher are not informed. Elsewhere, the numbers are computerized to determine whether the number is grape seed extract supplement or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jondishapur University of Medical Sciences
Street address
Golstan
City
Ahavz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.AJUMS.REC.1401.158

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
Body mass index
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
ترازو

2

Description
Waist-Hip Ratio (WHR)
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
Meter

3

Description
testosterone
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
ELISA kit

4

Description
prolactin
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
ELISA kit

5

Description
Luteinizing Hormone (LH)
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
ELISA kit

6

Description
Follicle-Stimulating Hormone (FSH)
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
ELISA kit

7

Description
Fasting insulin
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
ELISA kit

8

Description
Homeostatic Model Assessment for Insulin Resistance
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
Formula

9

Description
fasting blood sugar
Timepoint
before the start of the intervention and 8 weeks after taking the supplement
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They take a daily supplement of 250 mg of grape seed extract (GSE) for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: They take a placebo supplement daily for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Marzie Zilaiee
Street address
Azadegan
City
Ahvaz
Province
Khouzestan
Postal code
61936 73111
Phone
+98 61 3292 3985
Email
hemam@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilaiee
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilaiee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golstan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311 2713
Email
marziezilae67@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilaiee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golstan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2713
Email
marziezilae67@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilaiee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golstan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2713
Email
marziezilae67@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using the data to complete the research process regarding the effects of grape seed extract supplementation on the serum levels of androgens, gonadotropes, and high-sensitivity C-reactive protein in women with polycystic ovary syndrome.
From where data/document is obtainable
Contact the email of the Corresponding author of the article resulting from the data of the research project.
What processes are involved for a request to access data/document
Contact the email of the Corresponding author of the article resulting from the data of the research project.
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