In this study the effect of probiotics in gene expression which are effective in oxidative reduction will be studied and as regard promoter changes like adding methyl group have important role in the increase or decrease of gene expression, therefore; we will measure the promoter methylation of two important genes. In this study we will select 40 patients with type 2 diabetes, between 25-75 years old, without other diseases like heart disease, liver, and infection. According to evidence probiotic supplement can be more effective in the treatment of disease so we will fortify soymilk, as a substrate for these bacteria, with probiotics. Soymilk will fortify with Lactobacillus plantarum E7 in the concentration of 100000000 and will be consume for 8 weeks by patients. Before and after 8 weeks we will measure promoter methylation for MLH1 and MSH2, serum concentration of 8-oxo-2-deoxogovanosine, and superoxide dismutase activity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405265062N8
Registration date:2014-09-16, 1393/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-16, 1393/06/25
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
Isfahan University Of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of soy milk containing probiotics on promoter methylation and DNA damage among type-2 diabetic patients
Public title
The effect of probiotic soy milk in the treatment of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient with type 2 diabetes; between 25-75 years old; no consumption of vitamin supplement; antioxidants; mineral; omega-3 since 3 weeks ago.
Exclusion criteria: smokers; pregnant and lactating women; patients with liver disease; IBS; thyroid disease; Rheumatoid arthritis; infection; heart diseases; sever infection; disobedience of recommended diet
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Isfahan University of Medical Science, Hezarjarib street, Isfahan
City
Isfahan
Postal code
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
393150
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
MLH1 promoter methylation
Timepoint
Before and after intervention
Method of measurement
MethyQESD method
Secondary outcomes
1
Description
Serum concentration of 8-Oxo-2'-deoxyguanosine
Timepoint
Before intervention and after eighth week
Method of measurement
Eliza method
2
Description
MSH2 promoter methylation
Timepoint
Before intervention and after eighth week
Method of measurement
methyQESD method
3
Description
The activity of superoxide reductase
Timepoint
Before intervention and after eighth week
Method of measurement
Eliza method
Intervention groups
1
Description
Intervention group will consume probiotic soy milk containing 100000000 lactobacillus bacteria for 8 weeks.
Category
Prevention
2
Description
control group: In this group soy milk without probiotic will consume for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Metabolic and Endocrine Research Center
Full name of responsible person
Mitra Hariri
Street address
Isfahan University of Medical Sciences, Hezarjarib street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjarib 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
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Reza Ghiasvand
Position
PhD
Other areas of specialty/work
Street address
Departemant of Clinical Nutrition,Isfahan University of Medical Sciences, Hezarjarib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 6900
Fax
Email
rghiasvand@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
Other areas of specialty/work
Street address
Departemant of Clinical Nutrition, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+31 16623456
Fax
Email
ghiasvand@htlh.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
Reza Ghiasvand
Position
PhD
Other areas of specialty/work
Street address
Isfahn University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 6900
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)