Effects of low-calorie balanced diet containing wholegrain bread and wholegrain rice on indicators of metabolic syndrome in obese and overweight patients.
The aim of this study is to determine the effect of low-calorie balanced diet containing wholegrain bread and wholegrain rice on indicators of metabolic syndrome in obese and overweight patients.This study is a randomized clinical trial. In this study, obese and overweight people are invited.The number of samples was 80. Sampling is done on the basis of the balanced block.Participants based on balanced block, will be divided into two groups.
Wholegrain bread and wholegrain rice with low-calorie balanced diet will be given to the intervention group. In the second group, ordinary bread and ordinary rice with low calorie balanced diet will be given. intervention is 12 weeks.
At the beginning and end of the intervention, blood samples will be taken. And the parameters measured. Weight, waist circumference and blood pressure will be measured monthly..
Inclusion criteria:At least three of the indicators have metabolic syndrome : abdominal obesity; high blood sugar; high blood fat and blood pressure; People with obesity and overweight( body mass index greater than 25); Willingness to cooperate
Exclusion: disease leading to hospitalization; Or discharge from the hospital; the person is under a special regime; pregnant and lactating women; professional athletes; People with type 1 diabetes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062422905N1
Registration date:2016-09-25, 1395/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-25, 1395/07/04
Registrant information
Name
Mohadese Tondro
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 8653
Email address
stud2480112780@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy Shiraz University of Medical Sciences
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of low-calorie balanced diet containing wholegrain bread and wholegrain rice on indicators of metabolic syndrome in obese and overweight patients.
Public title
Effects of low-calorie balanced diet containing wholegrain bread and wholegrain rice on indicators of metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least three of the indicators have metabolic syndrome include: Abdominal obesity; High blood sugar; High blood fat; Blood pressure; People with obesity and overweight (BMI greater than 25); Willingness to cooperate
Exclusion: Disease leading to hospitalization or discharge from the hospital; The person is under a special regime; Pregnant and lactating women; Professional athletes; People with type 1 diabetes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
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
Research Deputy Shiraz University of Medical Sciences
Street address
Zand Blvd
City
Shiraz
Postal code
Approval date
2015-10-11, 1394/07/19
Ethics committee reference number
IR.SUMS.REC.1394.118
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E_66
ICD-10 code description
Obesity due to excess calories
2
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
3
Description of health condition studied
Hypertension
ICD-10 code
I15
ICD-10 code description
Secondary hypertension
4
Description of health condition studied
Hyperlipidaemia
ICD-10 code
E78
ICD-10 code description
Disorders of lipoprotein metabolism and other lipidaemias
Primary outcomes
1
Description
waist circumference
Timepoint
Early intervention, Fourth Week, Eight Week, End of intervention
Method of measurement
by meter.centimeter
2
Description
fasting blood sample
Timepoint
The beginning and end of the intervention
Method of measurement
measured by enzymatic spectrophotometry analysis.basiis mg/dl
3
Description
blood pressure
Timepoint
Early intervention, Fourth Week, Eight Week, End of intervention
Method of measurement
mmHg,with an automatic sphygmomanometer
4
Description
lipid profile
Timepoint
The beginning and end of the intervention
Method of measurement
measured by enzymatic spectrophotometry analysis.basis mg/dl
5
Description
Weight
Timepoint
Early intervention, Fourth Week, Eight Week,End of intervention
Method of measurement
scales Seca (made in Germany) and 1.0 kg accuracy.basis kg.
Secondary outcomes
1
Description
body mass index
Timepoint
The beginning and end of the intervention
Method of measurement
Measured height and weight
Intervention groups
1
Description
Intervention group:200 gram wholemeal bread and 100 gram wholegrain rice with a balanced low calorie diet for 12 weeks.
Category
Treatment - Other
2
Description
control Group: bread and white rice with a balanced low calorie diet for 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Clinic
Full name of responsible person
Mousa Salehi,PhD of Nutrition
Street address
Bargh St, Ghasrodasht Ave
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Dputy of Shiraz University of Medical Science
Full name of responsible person
Dr.Seyed Basir Hashemi
Street address
Zand Blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Dputy of Shiraz University of Medical Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Musa Salehi
Position
PhD/Associate Professor
Other areas of specialty/work
Street address
School of Nutrition and Food Science, Razi Blvd.
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
Salehi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Mmedical Sciences
Full name of responsible person
Mousa Salehi
Position
PhD/Associate Professor
Other areas of specialty/work
Street address
School of Ntrition and Food Science, Razi Blvd.
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
+98 37260225
Email
salehi@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
Mohadese Tondro
Position
Masters Student
Other areas of specialty/work
Street address
School of Nutrition and Food Science, Razi Blvd.
City
Shiraz
Postal code
Phone
+98 71 3231 8653
Fax
Email
Mt.darab@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)