The effect of DASH diet on Reproductive Hormonal , Plasma total antioxidant status and Anthropometric indices in Overweight and Obese Polycystic Ovary Syndrome Women
PCOS is the most common endocrine disorder in women and affects 6–8% of women of reproductive age. It is characterized by clinical or biochemical hyperandrogenism, oligo/amenorrhea, polycystic ovaries and infertility or reduced fertility. Objective: to determine the effect of DASH diet on reproductive hormonal status, total plasma antioxidant status and anthropometric indices in overweight and obese polycystic ovary syndrome women. Study design: parallel single-blind randomized controlled clinical trial. In this study 60 eligible women are selected. We have 2 groups: 30women follow DASH diet and 30women follow control diet. Both groups have calorie restriction (500-600 calorie).Patients were advised to continue physical activity habits without any changes during intervention. Before intervention and after 12 weeks participants are evaluated for anthropometric indices, body composition analysis, androgenic profile and total antioxidant capacity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121610826N16
Registration date:2014-12-28, 1393/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-28, 1393/10/07
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of DASH diet on Reproductive Hormonal , Plasma total antioxidant status and Anthropometric indices in Overweight and Obese Polycystic Ovary Syndrome Women
Public title
Effect of diet therapy in treatment of polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 20-40 years old; diagnosed with PCOS; BMI between 25 to 38; not using certain diet or drugs including contraceptives and metformin; not smoking; not doing heavy and professional exercise; not using of multivitamin supplements mineral and hormone therapy. Exclusion criteria: individuals with metabolic disorders; cardiovascular; kidney, adrenal, liver and thyroid diseases; changes in physical activity, do not compliance the diet.
Age
From 20 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)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
no.2m Shahid Sadoughi University of Medical Sciences, Bahonar square
Before intervention and 12 weeks after intervention
Method of measurement
Blood test
2
Description
Androstenedione
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Blood test
3
Description
SHBG (sex hormone-binding globulin )
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Blood test
4
Description
Body fat, percent of body fat, free fat mass, percent of free fat mass
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Body composition device
5
Description
Plasma antioxidant capacity
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Using DPPH powder
Secondary outcomes
1
Description
Weight
Timepoint
Sex hormone-binding globulin
Method of measurement
SECA scale with an accuracy of 0.1kg
2
Description
Free androgen index
Timepoint
Sex hormone-binding globulin
Method of measurement
Total testosterone/ SHBG
3
Description
Body Mass Index
Timepoint
Sex hormone-binding globulin
Method of measurement
weight/ height*height
4
Description
Waist circumference
Timepoint
Sex hormone-binding globulin
Method of measurement
By meter in cm
Intervention groups
1
Description
DASH diet designed based on calorie-restricted (500-600 kcal), a diet that emphasizes fruits, vegetables, and low-fat dairy products, that includes whole grains, poultry, fish, and nuts, that contains only small amounts of red meat, sweets, and sugar-containing beverages for 12weeks
Category
Lifestyle
2
Description
standard diet designed based on calorie-restricted (500-600 kcal), for 12weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqaie Poor clinic
Full name of responsible person
Maryam Azadi Yazdi
Street address
alley 33, Imam Khomeini Avenue
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Habib Nikookar
Street address
No. 2 building, Shahid Sadoughi University of Medical Sciences, Bahonar square NO. 2
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Maryam Azadi Yazdi
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
alley33, Imam Khomeini Avenue
City
Yazd
Postal code
8914759617
Phone
+98 35 3625 7499
Fax
Email
M_AZADI_Y@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Azadeh Najarzadeh
Position
PhD in Nutrition
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Imam Hossein square, Yazd
City
Yazd
Postal code
Phone
+98 356240691
Fax
Email
AZMM1383@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Maryam Azadi Yazdi
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
alley 33, Imam Khomeini avenue
City
Yazd
Postal code
8914759617
Phone
+98 35 3625 7499
Fax
Email
M_AZADI_Y@YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)