We aimed a randomized controlled clinical trial to determine the effects of Dietary Approaches to Stop Hypertension (DASH) diet on IRS and PPAR-γ gene expression in 60 healthy obese women who would be referred from health centers. Subject would not be have history of diabetes, heart failure, renal failure, hyperlipidemia, hormonal disease and supplement or drug consumption or weight loss more than 10% in six months earlier. They would be excluded if their weight would reduce more than 5% or they wouldn’t have adherence or incidence of disease. After 2 week run in participants would be randomly assigned to a control diet with healthy advices or the DASH eating pattern, each for 12 weeks . Finally IRS and PPAR-γ gene expression would be measured by real time PCR in blood monocyte and that would be compared between two groups by SPSS statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090719072N1
Registration date:2015-02-11, 1393/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-11, 1393/11/22
Registrant information
Name
Marzieh Kafeshani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3169
Email address
marzikafeshani@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-03-31, 1392/01/11
Expected recruitment end date
2015-06-30, 1394/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of DASH (Dietary Approach to Stop Hypertension) on IRS1 and PPARҮ2 Genes Expression in Obese Women
Public title
The Effect of Dietary Approach to Stop Hypertension (DASH) on Insulin Resistance
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion Criteria: female; Body Mass Index above 30; age 20-50; absence of cardiovascular; hepatic; renal; thyroid; diabetes; rheumatoid arthritis; lupus; severe infection; trauma; allergy disease; don't use of multivitamin and mineral or omega-3 fatty acids supplements; don't regular use of antacid drugs containing magnesium and calcium ; consumption Aspirin and Non Steroid Anti Inflammation; and anti-depressant and hormone drugs; lack of pregnancy and breastfeeding; don't get weight loss in 6 months (more than 1 kg; don't use of tobacco and alcohol.
Exclusion criteria: Failure to follow the prescribed diet( energy intake is different more than 300 calorie from prescribed as regard to food record analysis
), if weight change is more than 5%, diagnosis one of mentioned disease in inclusion criteria and using of chemical or herbal medicines during the study.
Age
From 20 years old to 49 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
Isfahan University OF Medical Science
Street address
Nutrition School, Isfahan University of Medical Science, Hezarjerib Street, Azadi Squre, Isfahan.
City
Isfahan
Postal code
Approval date
2013-07-06, 1392/04/15
Ethics committee reference number
392330
Health conditions studied
1
Description of health condition studied
healthy obese volunteer
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS
Primary outcomes
1
Description
PPAR gamma Gene Expression
Timepoint
Before Intervention and After 3 Months
Method of measurement
Real Time Polymerase Chain Reaction
2
Description
IRS1 Gene Expression
Timepoint
Before Intervention and After 3 Months
Method of measurement
Real Time Polymerase Chain Reaction
3
Description
insulin resistance
Timepoint
Before Intervention and After 3 Months
Method of measurement
Hemostatic Model Assessment(HOMA)
Secondary outcomes
1
Description
Weight
Timepoint
Before Study and After 3 Months
Method of measurement
Scale
2
Description
Fasting Sugar
Timepoint
Before Study and After 3 Months
Method of measurement
Caloremetric
3
Description
Fasting Insulin
Timepoint
Before Study and After 3 Month
Method of measurement
Elisa Method
Intervention groups
1
Description
The intervention group will prescribe DASH diet that is rich in fruits, vegetables, whole grains, and low fat dairy products, and low in saturated fat, total fat, cholesterol, refined grains and sweets .The diets would be prescribed weekly, and an exchange list would be given to each patient for exchanging food items and counting the calories. A nutritionist will teach subjects how to apply the exchange list and write food diaries. Every participant will bring her 3-day diet records every month, and the dairies would be reviewed by N4 nutritional software and their compliance would be assessed by analyzing the three food record diaries monthly and the attendance at meetings and monthly visits.
Category
Lifestyle
2
Description
The control group was recommended to “eat as usual” and received healthy dietary advises which would be printed on a paper .Every participant will bring his 3-day diet records every month, and the dairies would be reviewed by NUTRITIONIST 4 software and their diet was assessed by analyzing the three food record diaries.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Food Security Reserch Center
Full name of responsible person
Dr Mohammad Hasan Entezari
Street address
Nutrition School, Isfahan University of Medical Science, Hezarjerib Street, Azadi Squre, Isfahan,
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medica Science ,Deputy Director of Research and Development
Full name of responsible person
Dr Payman Adibi
Street address
Deputy Director of Research and Development, Isfahan University of Medical Science, Hezarjerib Street, Azadi Squre, Isfahan, ,
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medica Science ,Deputy Director of Research and Development
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
Isfahan University of Medical Science
Full name of responsible person
Dr Mohammad Hasan Entezari
Position
Assitanat Professor
Other areas of specialty/work
Street address
iNutrition School, Isfahan University of Medical Science, Hezarjerib Street, Azadi Squre, Isfahan.
City
Isfahan
Postal code
Phone
+98 31 3792 2776
Fax
Email
entezari@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr Mohammad hasan Entezari
Position
ASSISTANT PROFESSOR
Other areas of specialty/work
Street address
Nutrition School, Isfahan University of Medical Science, Hezarjerib Street, Azadi Squre, Isfahan.
City
ISFAHAN
Postal code
Phone
+98 31 3792 2767
Fax
Email
entezari@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Omolbanin Kafeshani
Position
PhD Student
Other areas of specialty/work
Street address
Nutrition School, Isfahan University of Medical Science, Hezarjerib Street, Azadi Squre, Isfahan,
City
Isfahan
Postal code
Phone
00
Fax
Email
marzikafeshani@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)