The effect of Garlic (Allium sativum) consumption on indices of oxidative stress, insulin resistance, lipid profile and testosterone hormone in women with polycystic ovary syndrome(PCOS)
The effect of garlic intake on oxidative stress, insulin resistance, lipid profile and testosterone hormone in women with PCOS
Design
This study is a double blind randomized clinical trial.
The block randomization method is used. The randomization unit is individual. The randomization tool is a random number table. The sample size is 68 people.
Settings and conduct
We select 68 women with PCOS referring to a gynecologist's office using available sampling.Then we randomly divide them into 2 groups of garlic and placebo tablets.Then their fasting blood samples are taken and we will give 800 mg of garlic or placebo tablet to each intervention group for daily intervention. After 8 weeks fasting blood samples will be taken to determine relevant markers.In this study, all participants, executor of plan, researcher, health care personnel such as physician and all laboratory personnel are kept blind to assigned study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:minimum age 18 and maximum 45 years
Not following a specific diet or exercise program
Not taking any of: Alcohol, tobacco, anti-estrogens, oral or injectable corticosteroids, anticoagulants like warfarin and heparin and not taking aspirin
No history of any allergy or intolerance to garlic and its products
Do not take garlic pills or supplements containing garlic at least 2 months before intervention
Not being pregnant, Lactation or menopause
No other endocrine disorders
Not using any drug or surgical treatment to treat clinical symptoms and disorders (PCOS) except OCP and metformin
Intervention groups
We will give 800 mg of garlic or placebo daily to each intervention group to start the intervention.
Main outcome variables
Effect of Garlic Tablets on Insulin Resistance of Glucose Levels, Antioxidant Capacity (TAC), Malondialdehyde (MDA), Lipid Profile and Testosterone Hormone in Patients with PCOS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161203031212N2
Registration date:2020-02-26, 1398/12/07
Registration timing:registered_while_recruiting
Last update:2020-02-26, 1398/12/07
Update count:1
Registration date
2020-02-26, 1398/12/07
Registrant information
Name
Forugh Fasihi
Name of organization / entity
Isfahan University of Medical Sciences, School of Nutrition and Food Sciences, Dept
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 7331
Email address
am.alavi@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Garlic (Allium sativum) consumption on indices of oxidative stress, insulin resistance, lipid profile and testosterone hormone in women with polycystic ovary syndrome(PCOS)
Public title
The effect of garlic on polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women with polycystic ovary syndrome who are at least 18 and up to 45 years old
Exclusion criteria:
People who follow a certain diet
People who follow a specific exercise program
People undergoing any drug treatment such as spironolactone, finasteride, isotretinoin, letrozole, clomiphene, gonadotropins, rosiglitazone, pioglitazone, or surgery such as laparoscopic ovarian surgery and assisted reproductive technology (PCOS) to treat symptoms they do
Any serious or significant systemic illness requiring treatment such as cancer, gastrointestinal, hepatic or endocrine disorders, thyroid dysfunction, diabetes mellitus, hyperprolactinemia, cardiovascular disorders, renal disorders, blood coagulation disorders, neurological disorders, Insomnia, Pemphigus Disease, Joint Rheumatism and Non-Related Reproductive Disorders (PCOS)
History of pregnancy hypertension
Family history of stroke
Any of the following: Alcohol, tobacco, anti-estrogens, oral or injectable corticosteroids
Pregnancy
lactation
Menopause
Use of anticoagulants such as warfarin and heparin, Taking aspirin
History of any allergy, intolerance or harmful drug reaction to garlic and its products
Taking garlic pills or supplements containing garlic at least 2 months before the intervention
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is used. The randomization unit is individual. The randomization tool is a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial. In this study, all participants, executor of plan, researcher, health care personnel such as physician and all laboratory personnel are kept blind to assigned study groups.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.187
Health conditions studied
1
Description of health condition studied
Polycystic Ovarian Syndrome(PCOS)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total Antioxidant Capacity (TAC)
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
serum level measurement
2
Description
Malon Di Aldehyde (MDA)
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
serum level measurement
3
Description
Lipid profile
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
serum level measurement
4
Description
Fasting blood sugar(FBS)
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
serum level measurement
5
Description
Insulin
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
serum level measurement
6
Description
Insulin Resistance (HOMA-IR)
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
serum level measurement
7
Description
Testosterone hormone
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
serum level measurement
Secondary outcomes
1
Description
blood pressure
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
sphygmomanometer
2
Description
Weight
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Balance
3
Description
Body Mass Index(BMI)
Timepoint
Before the intervention and 2 months after the intervention
Method of measurement
Balance and meter
Intervention groups
1
Description
Intervention group: The intervention group consumed 800 mg of garlic tablets daily for 2 months.
Category
Treatment - Other
2
Description
The control group consumed 800 mg of placebo daily for 2 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Amir Mansuor Alavi
Street address
Amin Hospital, Shohada Square, Ibn Sina Street
City
Esfahan
Province
Isfehan
Postal code
۸۱۴۸۶۵۳۱۴۱
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghyegh Haghjoui Javanmard
Street address
Vice chancellor for research, No 4 Bulding, Isfahan University of Medical Sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mansour Alavi Naini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School Of Nutrition & Food Sciences, Isfahan University of Medical Sciences,Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3154
Fax
+98 31 3668 1378
Email
am.alavi@nutr.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mansour Alavi Naini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School Of Nutrition & Food Sciences, Isfahan University of Medical Sciences,Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3154
Fax
+98 31 3668 1378
Email
am.alavi@nutr.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Roya Zadhoush
Position
Msc Student Nutrition Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School Of Nutrition & Food Sciences, Isfahan University of Medical Sciences,Hezarjarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3154
Email
danesh6020@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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
If the individual data of the sample is unrecognizable, sharing the whole data is fine.
When the data will become available and for how long
3 months after the results
To whom data/document is available
This data is only available to academic researchers.
Under which criteria data/document could be used
The data is for personal use only and is not licensed for analysis.
From where data/document is obtainable
Amir Mansour Alavi Naini
Email address: am.alavi@nutr.mui.ac.ir
What processes are involved for a request to access data/document
The applicant can send his application to the responsible author's email address and after reviewing the application, documentation is provided to the applicant.