The aims of this interventional study are to examine the effects of energy restricted low glycemic diet on hormonal and reproductive variables of PCOS women and to compare the effects of energy restricted diet on anthropometric and metabolic characteristics between women with or without PCOS.
This study will be included 30 PCOS women and 30 controls matched for BMI and age and will be recruited using convenience sampling. The case group will be recruited from PCOS women aged between 18-40 years, attending Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences. Healthy controls will be 30 age and BMI matched with PCOS women, who will be attending to the clinics of Shahid Beheshti University of Medical Sciences for annual gynecologic examinations. Sample size will be defined as 24 women in each group. Considering the loss of 20% of the subjects, 30 people will be determined for each group.
For every individuals, a low energy restricted diet will be designed based on BMI of 22-23 kg/m² and a deficit of 500 kcal per day over 24 weeks. Overnight fasting venous samples will be taken for assessment of glucose, insulin SHBG and testosterone, at 0-12 and 24 weeks. Anthropometric measurements will be taken at 0-12-24 weeks. The effect of restricted energy low GI diet on hirsutism at 0-12-24 weeks and on frequency of menstrual cycles and quality of life at 0-24 weeks will be estimated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092129909N1
Registration date:2016-12-08, 1395/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Farnaz Shishehgar
Name of organization / entity
Reproductive Endocrinology Research Center of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 4017
Email address
fshishehgar@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-10-18, 1395/07/27
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of interventions based on life style modification in women with polycystic ovarian syndrom
Public title
interventions based on lifestyle modification
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria
Diagnosis of PCOS according to Androgen Excess Society (AES) for PCOS criteria; All of participants will be in Persian language able to read and write; Age between 18-40 years old; BMI > 25 kg / m² and < 38 kg / m²; Absence of any chronic disease; Not taking the insulin-sensitizing agents; Not taking contraceptive drugs; No special diets or exercise for weight loss in past 6 months; Not Participating in previous similar studies; Not taking ovulation induction during in the past year; Not smoking or using alcohol; Not taking antihypertensive drugs; Lack of mental disease or depression; No history of any type of malignancy
Exclusion criteria: Being pregnant; Lactation in the past year; Bleeding of unknown cause
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 research institute for endocrine sciences, Shahid Beheshti University of Medical