Incidence of metabolic syndrome and the effect of the modified Mediterranean diet for prevention of metabolic syndrome in patients undergoing liver transplantation
The aims of this study is to investigate the effects of modified Mediterranean diet on the incidence of Metabolic Syndrome after liver transplantation.Inclusion criteria:age over 18 exclusion criteria: age under 18; patient with any malignancy; multivisceral transplant; malignancy during stud.
One hundred fifty adult elective liver transplantation recipients will enroll and divide into two groups: the control group (n = 85) and the standard diet ( n = 65). Primary outcome time point will be 1, 2, 3 and 4 months after liver transplantation.We will measure: systolic and diastolic blood pressure, waist circumference; Metabolic Syndrome and serum levels of fasting blood glucose, triglycerides and others laboratory factors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012720841N1
Registration date:2015-02-12, 1393/11/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-12, 1393/11/23
Registrant information
Name
Seyed Jalil Masoumi
Name of organization / entity
Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
kheradm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-09, 1394/01/20
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Incidence of metabolic syndrome and the effect of the modified Mediterranean diet for prevention of metabolic syndrome in patients undergoing liver transplantation
Public title
Effect of the modified Mediterranean diet for prevention of metabolic syndrome in patients undergoing liver transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:age over 18 exclusion criteria: age under 18; patient with any malignancy; multivisceral transplant; malignancy during study; Patients who do not want to cooperate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shiraz University of Medical Sciences
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2014-12-21, 1393/09/30
Ethics committee reference number
6554
Health conditions studied
1
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E78.1
ICD-10 code description
Pure hyperglyceridaemia
2
Description of health condition studied
Metabolic Syndrome
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
3
Description of health condition studied
Metabolic Syndrome
ICD-10 code
R73
ICD-10 code description
Elevated blood glucose level
4
Description of health condition studied
Metabolic Syndrome
ICD-10 code
R63.5
ICD-10 code description
Abnormal weight gain
5
Description of health condition studied
Metabolic Syndrome
ICD-10 code
E78.6
ICD-10 code description
Lipoprotein deficiency
Primary outcomes
1
Description
Blood Pressure
Timepoint
Every 4 weeks till 16 weeks
Method of measurement
By a sphygmomanometer
2
Description
Weight
Timepoint
Every 4 weeks till 16 weeks
Method of measurement
Iranian Rasa company scale
3
Description
Waist circumference
Timepoint
Every 4 weeks till 16 weeks
Method of measurement
Meters of fabric
4
Description
blood suger tests
Timepoint
Every 4 weeks till 16 weeks
Method of measurement
by an automated clinical chemistry analyzer
5
Description
Lipid profile ( TG,CHOL,HDL-C,LDL-C )
Timepoint
Every 4 weeks till 16 weeks
Method of measurement
By an automated clinical chemistry analyzer
Secondary outcomes
empty
Intervention groups
1
Description
In treatment group, a MMD with some changes in its contents in response to Iranian dietary culture and adapted with anthropomorphic conditions for 16 weeks. This diet rich in whole grains, legumes, vegetables, fruits consumed in the diet of fat is olive oil and canola oil, daily consumption of white meat and red meat consumption will be weekly. The regime will use low-fat dairy and sugar consumption is extremely low.
Category
Prevention
2
Description
Control group will use diet and training routine that normally provided by the hospital nutritionists.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Organ Transplantation Center, Nemazee Hospital
Full name of responsible person
Seyed Jalil Masoumi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Seyed BasirHashemi
Street address
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medic
Full name of responsible person
Seyed Jalil Masoumi
Position
Teacher
Other areas of specialty/work
Street address
BLV Razi,School of Nutrition and Food Sciences, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
massoumij@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Jalil Masoumi
Position
Teacher
Other areas of specialty/work
Street address
BLV Razi, School of Nutrition and Food Sciences, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
massoumij@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Jalil Masoumi
Position
Teacher
Other areas of specialty/work
Street address
BLV Razi, School of Nutrition and Food Sciences, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)