The aim of this study is to determine the effect of yogurt and yogurt plus shallot intake on lipid profiles in type 2 diabetic women. This study will be a parallel randomized clinical trial. 48 women with type 2 diabetes will be enrolled to study. Inclusion criteria will be defined as female gender; age between 45-70 years old and not being on insulin therapy. Subjects will be excluded if pregnancy happens or participants use insulin therapy. Subjects will randomly be divided into two groups The first group will be received 150 milliliters of low fat yogurt (1.5% fat) daily and Second group will be received 150 milliliters of yogurt plus shallot (1.5% fat) daily. This study will be lasted for 10 weeks. Anthropometric indices will be measured before and after intervention period. Fasting blood sugar, Serum triglyceride, LDL-C, and total cholesterol concentration of each participant will be measured before and after 10 weeks intervention and the values will be compared within each group before and after intervention and between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508185062N10
Registration date:2016-02-27, 1394/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-27, 1394/12/08
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Food Security Research Center, Isfahan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of yogurt and yogurt plus shallot consumption on lipid profiles in type 2 diabetic women
Public title
Effect of yogurt and yogurt plus shallot consumption on lipid profile
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female gender; age between 45-70 years old and not use of insulin therapy
Exclusion criteria: pregnancy; use of insulin therapy.
Age
From 45 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Postal code
Approval date
2012-04-28, 1391/02/09
Ethics committee reference number
391098
Health conditions studied
1
Description of health condition studied
Type II diabates
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
LDL-C
Timepoint
Before start of the intervention and after the intervention
Method of measurement
Blood biochemical test
2
Description
Total cholesterol
Timepoint
Before start of the intervention and after the intervention
Method of measurement
Blood biochemical test
3
Description
Triglyceride
Timepoint
Before start of the intervention and after the intervention
Method of measurement
Blood biochemical test
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Before start f the intervention and after the intervention
Method of measurement
biochemical blood test
Intervention groups
1
Description
First intervention group: in the first group participants will be received 150 milliliter of low fat yogurt (1.5% fat) daily for 10 week
Category
Other
2
Description
Second intervention group: second group will be received 150 milliliter of low fat yogurt plus shallot (1.5% fat) daily for 10 week.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrinology Research Center
Full name of responsible person
Sanaz Mehrabani, Master of nutrition Science
Street address
Sedigheh Tahere Research Center, Khorram St., Jomhori Eslami St.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Food Safety Research center
Full name of responsible person
Dr Leila Azadbakht
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Food Safety Research center
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
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, Isfahan University of Medical Sciences
Proportion provided by this source
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 Sciences, School of Nutrition and Food Science
Full name of responsible person
Sanaz Mehrabani
Position
Master of nutrition science
Other areas of specialty/work
Street address
Department of Nutrition and Food Sciences, Isfahan University of Medical Science, Hezar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 3435 9511
Fax
Email
sanaz_mehr6500@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Ghiasvand
Position
PhD of nutrition science
Other areas of specialty/work
Street address
Department of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 3792 2749
Fax
Email
ghiasvand@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Sanaz Mehrabani
Position
Master of nutrition science
Other areas of specialty/work
Street address
Department of Nutrition and Food Sciences, Isfahan University of Medical Science, Hezar Jarib St.
City
Isfahan
Postal code
Phone
+98 31 3435 9511
Fax
Email
sanaz_mehr6500@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)