This study was aimed to assess the effect of nutrition education on the level of changes of Insulin, FBS and HOMA index in fasting individual.
This was an interventional study. A total of 160 volunteer people who were decided to definitely fast during oncoming month of Ramadan were identified and selected from mosques in the city of Kermanshah.
Participants were divided randomly into two groups. The intervention group was trained for proper nutrition before and during Ramadan.
The two groups were matched for age and socioeconomic status.
Body composition and blood parameters was measured three times: a week before Ramadan, at the end of Ramadan and one month after Ramadan.
Outcome variables were FBS, Insulin and HOMA index.
Inclusion criteria were male, aged 20 to 60 years and fasting and Exclusion criteria were cut fasting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702269856N5
Registration date:2017-04-29, 1396/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-29, 1396/02/09
Registrant information
Name
Yahya Pasdar
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 1991
Email address
yahya.pasdar@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nutrition education on blood glucose and insulin resistance in men fasting in Kermanshah
Public title
The effect of nutrition education on blood glucose and insulin resistance in men fasting in Kermanshah
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria : male; agd 20-60 years; a complete fasting during Ramadan; the lack of underlying disease
Exclusion criteria : cut fasting during Ramadan for any reason
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Ethics CommitteeKermanshah University of Medical Sciences
Street address
Kermanshah
City
Kermanshah
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
KUMS.REC.1394.481
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FBS
Timepoint
Before intervention, After intervention
Method of measurement
By getting a blood samples from the participants and measured with laboratory kits
2
Description
Insulin
Timepoint
Before intervention, After intervention
Method of measurement
By getting a blood samples from the participants and measured with laboratory kits
Secondary outcomes
1
Description
HOMA (homeostasis model assessment)
Timepoint
Before intervention, After intervention
Method of measurement
[FPI (mIU/L) × FPG (mmol/L)]/22.5
Intervention groups
1
Description
The intervention group before and during Ramadan are trained on how to proper nutrition. Nutritional science education pamphlets in simple language and approved by nutrition educators will be
Category
Lifestyle
2
Description
The control group received no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Public Health
Full name of responsible person
Dr Yahya pasdar
Street address
Department of Nutrition, Faculty of Public Health, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrooz Hamzeh
Street address
Vice Chancellor for Research and Information Technology Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Darbandi
Position
MSc in Epidemiology, Researcher
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Dolat Abad, Isar Square, Kermanshah
City
Kermanshah
Postal code
6719851351
Phone
+98 83 3828 1991
Fax
+98 83 3826 3048
Email
mitra.darbandi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Yahya Pasdar
Position
Ph.D in Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Dolat Abad, Isar Square, Kermanshah
City
Kermanshah
Postal code
6719851351
Phone
+98 83 3828 1991
Fax
+98 83 3826 3048
Email
yahya.pasdar@gmail.com yahya.pasdar@kums.ac.ir
Web page address
www.drpasdar.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Darbandi
Position
MSc in Epidemiology, Researcher
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Dolat Abad, Isar Square, Kermanshah
City
Kermanshah
Postal code
6719851351
Phone
+98 83 3828 1991
Fax
+98 83 3826 3048
Email
mitra.darbandi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)