Effects of the hypocaloric DASH diet on metabolic parameters, inflammatory factor and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome
Objective: The aim of this study is to determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome (PCOS). Study design: parallel single-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-35 years with overweight and obese diagnosed with PCOS will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 women with PCOS 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 the DASH diet (intervention group: n=30) or the standard diet (control group: n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 8 weeks (April 23, 2013-June 17, 2013). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304235623N6
Registration date:2013-05-04, 1392/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2013-05-04, 1392/02/14
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
2013-04-23, 1392/02/03
Expected recruitment end date
2013-06-18, 1392/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of the hypocaloric DASH diet on metabolic parameters, inflammatory factor and biomarkers of oxidative stress in overweight and obese women with polycystic ovary syndrome
Public title
Effect of diet therapy in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Women aged 18-35 years; diagnosed with PCOS.
Exclusion Criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; antidiabetic medications; anti-obesity medications.
Control group: Standard diet designed based on calorie-restricted (500 kcal), 3 serving vegetables, 3 serving fruits, rich in protein, daily for 8 weeks
Category
Other
2
Description
Intervention group: DASH diet designed based on calorie-restricted (500 kcal), 5 serving vegetables, 5 serving fruits, rich in fiber and whole grains, daily for 8 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_r@yahoo.comasemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_r@yahoo.comasemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)