Objective: The aim of this study is to determine the effects of soy isoflavone supplementation on lipid profiles in patients with polycystic ovary syndrome (PCOS). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with PCOS according to Rotterdam criteria, higher than 5 years of their disease and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 70 patients with PCOS of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either soy isoflavone supplements (intervention group: n=35) or placebo (control group: n=35). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 3 months. Outcomes: Lipid profiles will be measured at study baseline and End-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604015623N70
Registration date:2016-04-07, 1395/01/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-07, 1395/01/19
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2016-02-29, 1394/12/10
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of soy isoflavone supplementation compared with the placebo on lipid profiles in women with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of women with polycystic ovary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with PCOS according to Rotterdam criteria; higher than 5 years of their disease; aged 18 to 40 years.
Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Random assignment will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.Kaums.REC.1394.171
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Secondary outcomes
1
Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention