The aim of this study was to evaluate the effects of flax seed on patient with poly-cystic ovarian syndrome .
Design
Double blind randomized parallel clinical trial with two groups of control and intervention with a sample size of 84
Settings and conduct
select Poly-cystic Ovarian Syndrome patients based on inclusion and exclusion criteria that refered to zeinabieh clinic. then completed consent and other questionnaires for participants.finally patients settled on either groups based on randomisation. Patients will not be aware of the two groups being studied
Participants/Inclusion and exclusion criteria
Inclusion criteria : Diagnosis of Poly-cystic Ovarian Syndrome Based on Rotterdam Criteria By clinical practitioner, age 18 to 40
Exclusion criteria : Family history of breast, ovarian or uterine cancer,
Pregnancy or lactation,
Diabetes, thyroid disease or any systemic disease,
Other disorders that lead to increased androgens in the blood,
Menopause,
Use of special drugs
Intervention groups
Intervention group: 30 grams of flax seed powder daily for 8 week in addition to weight loss diet and nutrition recommendations
Control group: 30 grams of rice powder daily for 8 week in addition to weight loss diet and nutrition recommendations
Main outcome variables
Changes in glycemic indexes, changes in lipid factors, hormonal changes, weight change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170916036204N8
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Najmeh Hejazi
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1005
Email address
nhejazi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Flaxseed on Glycemic Indices, Lipid Profile, Hormones and Anthropometric Measurements on PCOS Patients
Public title
Evaluating the Effect of Flaxseed on PCOS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Polycystic Ovarian Syndrome Based on Rotterdam Criteria By clinical practitioner
Exclusion criteria:
Family history of breast, ovarian or uterine cancer
Alcohol or drug use
Pregnancy or lactation
Use of anti-hypertension and lipid lowering drugs
Metformin use 6 months before enrollment and during the study
Diabetes, thyroid disease or any systemic disease (eg kidney, liver, digestive system, cardiovascular)
Other disorders that lead to increased androgens in the blood (such as Cushing's syndrome, hyper prolactinemia)
Menopause
Use of drugs that affect glucose metabolism
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with fixed block size of four
Blinding (investigator's opinion)
Double blinded
Blinding description
The sachets presented to the control group are filled with colored rice powder, with the same appearance and packaging as those given to intervention group. So the patients do not recognize which of the two groups they are in. Also, the physician and the data analyst are unaware of this.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Iran, Fars,Shiraz,Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.SUMS.REC.1398.711
Health conditions studied
1
Description of health condition studied
poly-cystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
ّFasting Blood Sugar
Timepoint
At the beginning and the end of the study (after 8 weeks )
Method of measurement
FBS kit
2
Description
Insulin
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Insulin kit
Secondary outcomes
1
Description
Luteinizing Hormone
Timepoint
At the beginning and the end of the study (after 8 weeks )
Method of measurement
Luteinizing Hormone kit
2
Description
Follicle-Stimulating Hormone
Timepoint
At the beginning and the end of the study (after 8 weeks )
Method of measurement
Follicle-Stimulating Hormone kit
Intervention groups
1
Description
Intervention group: 30 grams of flax seed powder daily for 8 week in addition to weight loss diet and nutrition recommendations
Category
Treatment - Other
2
Description
Control group: 30 grams of rice powder daily for 8 week in addition to weight loss diet and nutrition recommendations
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeinabieh clinic
Full name of responsible person
Zahra Moghdani
Street address
Zeinabieh clinic, Shiraz university of medical science
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
zahra.moghdani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
ِِDoctor Yunes Ghasemi
Street address
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Moghdani
Position
Master of Science in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
zahra.moghdani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Hejazi
Position
PHD in Nutrition Sciences, Assistant Professor of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Nhejazi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Moghdani
Position
Master of Science in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Science, Fatholmobin Alley, Razi Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
zahra.moghdani@gmail.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
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