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Effect of flaxseed powder on levels of the glycemic indices, lipid Profile, inflammatory factors, adipocytokines and androgen profile in women with polycystic ovarian syndrome

Protocol summary

Study aim
Determination of the effect of flaxseed powder on levels of the glycemic indices, lipid Profile,inflammatory factors, adipocytokines and androgen profile in women with polycystic ovarian syndrome
Design
This is a randomized unblinded clinical trial with two parallel groups in Phase 3. In this research, 56 eligible patients referring to Polycystic ovarian syndrome were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This study will be conducted at the Jundishapur University of Medical Sciences in Ahwaz, and the diagnosis will be done at the specialized clinic of Golestan Hospital.In this study, after sampling and randomization, the intervention group daily received 3 grams of granule powder for 3 months.Both groups interventions and control receive recommendations for lifestyle modification.At the beginning and the end of the study, fasting blood samples will be taken from patients to measure lipid profiles, glycemic, testosterone, SHBG, IL-6, hs-CRP, leptin and adipontin.
Participants/Inclusion and exclusion criteria
Patients with polycystic ovary syndrome based on Rotterdam criteria Age 20-45 years Lack of heart disease, kidney disease, diabetes, thyroid, liver and cancer Not pregnant or pregnant. Lack of food allergy to flaxseed or other similar seeds such as sesame Failure to follow a weight loss program during the study
Intervention groups
women with polycystic ovary syndrome who receive 30 grams of flaxseed powder daily for 12 weeks.
Main outcome variables
Insulin resistance; Testosterone level; SHBG level; Leptin and Adiponectin levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120704010181N11
Registration date: 2018-01-21, 1396/11/01
Registration timing: retrospective

Last update: 2018-01-21, 1396/11/01
Update count: 0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2017-12-20, 1396/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of flaxseed powder on levels of the glycemic indices, lipid Profile, inflammatory factors, adipocytokines and androgen profile in women with polycystic ovarian syndrome
Public title
The effect of flaxseed powder on the treatment of polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovarian syndrome BMI less than 35 kg/m2
Exclusion criteria:
Chronic diseases such as heart disease, diabetes, cancer, Thyroid gland disorders Following the weight loss program in the last 6 months. Taking any nutritional supplement Pregnancy
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Simple (assigning a person to a particular group completely randomly) using a random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-11-20, 1396/08/29
Ethics committee reference number
IR.AJUMS.REC.1396.619

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Testosterone levels
Timepoint
At the beginning and end of the study
Method of measurement
Using ELISA Kit

2

Description
SHBG levels
Timepoint
At the beginning and end of the study
Method of measurement
Using ELISA Kit

3

Description
Serum levels of insulin
Timepoint
At the beginning and end of the study
Method of measurement
Using ELISA Kit

4

Description
Insulin resistance
Timepoint
At the beginning and end of the study
Method of measurement
Using HOMA-IR equation

5

Description
Insulin sensitivity
Timepoint
At the beginning and end of the study
Method of measurement
Using QUICKI equation

Secondary outcomes

1

Description
Grade Hirsutism Based on Freeman Galway questionnaire, Score more than 8
Timepoint
At the beginning and end of the study
Method of measurement
Based on Freeman Gallo's Questionnaire

2

Description
Menstrual Cycle
Timepoint
At the beginning and end of the study
Method of measurement
Based on individual interviews

Intervention groups

1

Description
Intervention group: Patients with polycystic ovarian syndrome who receive a daily dose of 30 grams of flaxseed for 12 weeks together with recommendations for lifestyle modification.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
کلینیک تخصصی بیمارستان گلستان
Full name of responsible person
محمد علی شیخی
Street address
اتوبان گلستان
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3384 3001
Email
sheikhi-m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
badavi-m@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
Nasrin Banaei
Position
Master of Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
banaei.n@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Haidari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Email
haidari-f@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Banaei
Position
Master of Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
n.banaei@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
it is not the objective of this study.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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