Effect of green coffee supplement on the level of androgen in women with poly-cystic ovary syndrome
Design
This study is a Double-blind study clinical trial with parallel groups that is divided into two groups of treatment and control. The study groups are women with polycystic ovarian syndrome. In this study, a randomized block method was used in which encoded patients Each patient is given codes for each patient, and patients are divided into two groups. The sample size is 40.
Settings and conduct
Sampling from Shariati clinic has been done
Participants/Inclusion and exclusion criteria
Entry requirements
Metformin, Collofen, Letrozole, HMG and HCG, Folic Acid
The age group is 20 to 40 years old.
Body mass index has 18.5-34.9 kg / m2 or more.
No entry
Having a decision to have a pregnancy during the study period
Having sensitivity and intolerance to the green coffee supplement
There are thyroid and renal disorders
Consuming food supplements
Intervention groups
The intervention group received green coffee pills and the control group received the placebo
Main outcome variables
Changes of FREE TESTOSTERON-ANDRESTANDION-DIHYDROTESTOSTERO -LDL-CHOLESTEROL-TG_FBS-INSULIN and increase of HDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180711040428N1
Registration date:2018-10-15, 1397/07/23
Registration timing:retrospective
Last update:2018-10-15, 1397/07/23
Update count:0
Registration date
2018-10-15, 1397/07/23
Registrant information
Name
Ahmad Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3721 2586
Email address
ahmad.mousavi@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-22, 1397/04/31
Expected recruitment end date
2018-07-28, 1397/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of green coffee supplementation on androgens levels in patients with polycystic ovary syndrome
Public title
The effect of green coffee supplementation on patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having polycystic ovarian syndrome
Age group between 20 and 40 years old
Use of pcos syndrome drugs
Body mass index from 18.5 to 39.9
Exclusion criteria:
The desire to get pregnant while studying
Being pregnant
Thyroid and renal failure
Consuming food supplements
Coffee susceptibility
Acute abnormalities in women with polycystic ovary syndrome during the research period
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
randomize block design
Blinding (investigator's opinion)
Triple blinded
Blinding description
The complementary method in this study is double-blind, so that the researcher and the participants are not supplemented (placebo or green coffee), and the other person is responsible for the coding of supplements and placebo, which is an add-on supplement Each group receives (intervention or control) is informed. The patients are then supplemented by a researcher who does not have supplemental information, and at the end of the laboratory assessment is done blind, because the lab does not have any knowledge of the study. After evaluations and at the end of the study, the type of encoded supplements is revealed to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research, Research Branch, Islamic Azad University
Street address
Azad
City
Tehran
Province
Tehran
Postal code
۱۱۱۱۱۱۱۱۱۱۱۱۱۱۱۱۱۱۱
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.IAU.SRB.REC.1396.108
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrom
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Androgens
Timepoint
Before starting the study and 60 days after taking the green coffee pill
Method of measurement
Elisa device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The blood samples are taken prior to the intervention and the serum is isolated. Then, the level of androgens and lipid and sugar determinants is measured by ELISA method, and this group will receive 2 tablets of 500 milligrams of green coffee for the period of 60 days with lunch The blood samples are taken again and the factors listed above are measured again. The main ingredients are green chlorine acid and caffeine. For each person, two training sessions are provided.
Category
Treatment - Other
2
Description
Control group:The blood samples are taken before the intervention and the serum is isolated. Then, the level of androgens and lipid and sugar determinants is measured by ELISA method, and this group received 2 500 mg tablets of 500 mg of placebo for the 60 day lunch meal for 60 days. The blood samples are taken again and the level of the factors mentioned above is measured. The main place of placebo is flour. Each training session is provided for each person.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Clinic
Full name of responsible person
Ahmad mousavi
Street address
Karegar
City
Tehran
Province
Tehran
Postal code
۱۱۱۱۱۱۱۱۱۱۱
Phone
+98 21 3333 3333
Fax
Email
Ahmadmousavi7772@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
احمد موسوی
Street address
Azad
City
Tehran
Province
Tehran
Postal code
۱۱۱۱۱۱۱۱
Phone
+98 21 4486 5154
Email
Ahmadmousavi7772@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
30
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
Islamic Azad University
Full name of responsible person
Ahmad saedi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Azad
City
Tehran
Province
Tehran
Postal code
۱۱۱۱۱۱۱۱
Phone
+98 21 4486 5154
Email
Ahmadmousavi7772@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fghjjj
Position
Jjdmdk
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghdhdb
City
Gshhsjs
Province
Tehran
Postal code
۱۱۱۱۱۱۱۱۱۱
Phone
+98 0217777778
Email
Fsgshjsksk@ghsjs.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gssjsjak
Position
Hzjsjjs
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hzhsh
City
Tehran
Province
Tehran
Postal code
۱۱۱۱۱۱۱۱۱
Phone
+98 2178747474747
Email
Absjsjjsjsj@hshhs.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
All sections of the protocol and analyzes of the study and clinical reports will be shared
When the data will become available and for how long
It is currently unclear
To whom data/document is available
All people are allowed to use this documentation
Under which criteria data/document could be used
Sometimes people can use this document for their purpose to use this documentation of therapeutic and research applications
From where data/document is obtainable
Can access documents through email
What processes are involved for a request to access data/document
The applicant can receive the documentation after identifying his identity