IRCT | The Effect of Grape Seed Extract (GSE) Supplementation on Fasting Blood Sugar Status, Insulin Resistance and Lipid Profile in Women with Polycystic Ovary Syndrome (PCOS)

Protocol summary

Study aim: The effect of grape seed extract (GSE) supplementation on fasting blood sugar status, insulin resistance and lipid profile in women with polycystic ovary syndrome
Design: Patients (n = 50) were randomly divided into 2 groups of 25. The intervention group daily consumes a 250mg grape seed extract (GSE) supplement for 8 weeks. Patients in the control group daily take one 250mg of placebo that is complementary in terms of color and size. Grape Core Extract Supplement (GSE) from Shari Dar (Iran) Co. To assess the biochemical properties of 10cc fasting blood samples, 10 to 12 hours of fasting will be collected at the beginning and end of the study. In this intervention, blood sampling will be carried out by a qualified laboratory scientist. Samples are separated at a maximum of 1 hour for 10 minutes with 2000 rounds and serum. . The plasma and serum samples were stored in a freezer, and transferred to the Snijders Scientific Freezer Hospital for a few days, and kept there until the tests were performed. The serum will be used to carry out biochemical tests for fasting blood glucose, lipid profile, and insulin.
Settings and conduct: Golestan Hospital ahwaz
Participants/Inclusion and exclusion criteria: Entry criteria: Age 25 to 60 years, Body mass index less than or equal to 30, PCOS diagnosis, defined as the presence of 2 attributes of the following 3 characteristics: oligo-evolution or non-ovulation, biochemical and / or clinical evidence of hyperandrogenism, features Transvaginal ultrasonography, representing more than 12 immature follicles less than 10 mm per ovary
Intervention groups: The intervention group daily consumes a 250 mg grape seed extract (GSE) supplement for 8 weeks.
Main outcome variables: The starting point in the cognitive process is to use one of the nutrition management strategies for this disease in further research.

General information

Reason for update
Acronym: GSE-PCOS
IRCT registration information: IRCT registration number: IRCT20190122042458N1

Registration date: 2019-09-04, 1398/06/13

Registration timing: registered_while_recruiting

Last update: 2019-09-04, 1398/06/13

Update count: 0
Registration date: 2019-09-04, 1398/06/13

Registrant information: Name

pegahe sedighii

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 3360 5280

Email address

amiraryan89@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2019-07-11, 1398/04/20
Expected recruitment end date: 2019-09-23, 1398/07/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The Effect of Grape Seed Extract (GSE) Supplementation on Fasting Blood Sugar Status, Insulin Resistance and Lipid Profile in Women with Polycystic Ovary Syndrome (PCOS)

Public title: The Effect of Grape Seed Extract Supplementation on Fasting Blood Sugar Status, Insulin Resistance and Lipid Profile in Women with Polycystic Ovary Syndrome
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age of Admission 25 to 60 Years Body Mass Index Less than or Equal to 30 Diagnosis of Women with Polycystic Ovarian Syndrome Defined as Presence of 2 Characteristics of the Following 3 Characteristics: Oligoavulation or non Ovulation, Biochemical and / or Clinical Evidence of Hyperandrogenism, Features of Transvaginal Ultrasonography Representing More than 12 Immature Follicles Less than 10 mm Per Ovary

Exclusion criteria:

Unwillingness of Patients to Participate in the Study Kidney Disease, Coronary Arteries, Acute and Chronic Pulmonary Inflammation, Short Stomach and Intestine Syndrome, Allergies Pregnancy and Lactation Traveling for More than 2 Weeks Smokers Use of Food Supplements Anti-Inflammatory Drugs Use of any Antioxidant Supplement in the Last 3 Months Use of Immunosuppressive Drugs Follow Certain Diets Change the Diet or Decide to Lose Weight
Age: From 25 years old to 60 years old
Gender: Female

Phase

N/A

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Not randomized

Randomization description

Blinding (investigator's opinion)

Double blinded

Blinding description

Participants Do not know Which Control Groups or Witness Group are Located. Investigator and Attending Medical Personnel and Data Collectors Do not know the Presence of Participants In the Witness Group or Control Group.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

IR.AJUMS.REC.1398.236

Street address

Golestan -hospital

City

Ahwaz

Province

Khouzestan

Postal code

1853913336
Approval date: 2019-06-24, 1398/04/03
Ethics committee reference number: IR.AJUMS.REC.1398.236

Health conditions studied

1

Description of health condition studied: Polycystic Ovary Syndrome(PCOS)
ICD-10 code: P05.08
ICD-10 code description: Newborn light for gestational age, 2000-2499 grams

Primary outcomes

1

Description: HDL
Timepoint: 0-60
Method of measurement: Laboratory Kits

2

Description: LDL
Timepoint: 0-60
Method of measurement: Laboratory Kits

3

Description: T.G
Timepoint: 0-60
Method of measurement: Laboratory Kits

4

Description: FBS
Timepoint: 0-60
Method of measurement: Laboratory Kits

5

Description: Insulin resistance
Timepoint: 0-60
Method of measurement: Laboratory Kits

6

Description: Insulin
Timepoint: 0-60
Method of measurement: Laboratory Kits

Secondary outcomes

empty

Intervention groups

1

Description: Intervention Group: Includes 25 Patients Who Will be Randomly Selected and Treated With Placebo Orally For Two Months.
Category: Placebo

2

Description: Control Group: Includes 25 Patients Who Will be Treated With Grape Seed Dupplements For Two Months, Supplemented By Grape Seed Purchased From Shari Drug Company, Which Will Be Given 250 mg Orally Daily.
Category: Diagnosis

Recruitment centers

1

Recruitment center: Name of recruitment center

Golestani Hospital, ahwaz

Full name of responsible person

Pegah Sedighii

Street address

Golestani Hospital, Ahwaz

City

Ahwaz

Province

Khouzestan

Postal code

1853913336

Phone

+98 21 3360 5280

Fax

+98 21 3360 5280

Email

Amiraryan89@yahoo.com

1

Sponsor: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Pegah Sedighi

Street address

Golestani Hospital, Ahvaz

City

Ahvaz

Province

Khouzestan

Postal code

1853913336

Phone

+98 21 3360 5280

Fax

+98 21 3360 5280

Email

amiraryan89@yahoo.com
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

Pegah Sedighii

Position

Master of Science (MSc)

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Golestan Hospital

City

Ahvaz

Province

Khouzestan

Postal code

1859313336

Phone

+98 21 3360 5280

Fax

+98 21 3360 5280

Email

Amiraryan89@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Pegah Sedighii

Position

Master of Science (MSc)

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Golestan Haspitan

City

Ahvaz

Province

Khouzestan

Postal code

1859313336

Phone

+98 21 3360 5280

Fax

+98 21 3360 5280

Email

amiraryan89@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Pegah Sedighii

Position

MSc

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Golestan Hospital

City

Ahvaz

Province

Khouzestan

Postal code

1859313336

Phone

+98 21 3360 5280

Fax

+98 21 3360 5280

Email

amiraryan89@yahoo.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: No - There is not 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: After Collecting the Data in the Form of the Final Report of the Dissertation, it Will be Available to Ahwaz University of Medical Sciences.
When the data will become available and for how long: Start of Access 3 Months After Printing Results
To whom data/document is available: Project Implementers
Under which criteria data/document could be used: Based on the laws of Ahwaz University of Medical Sciences
From where data/document is obtainable: Ahwaz University of Medical Sciences
What processes are involved for a request to access data/document: Ahwaz University of Medical Sciences Assistant Professor of Nutrition
Comments

The Effect of Grape Seed Extract (GSE) Supplementation on Fasting Blood Sugar Status, Insulin Resistance and Lipid Profile in Women with Polycystic Ovary Syndrome (PCOS)