Protocol summary

Summary
Object: Determination the effect of probiotic fermented milk on lipid profiles, serum level of glucose and hs-CRP diabetic patients. Inclusion criteria: Person with diabetes, Ages 30 to 60 years. Exclusion criteria: not using cholesterol lowering drugs, not using anti inflammatory drugs, not using insulin therapy. 60 persons total( 30 persons for each group). Intervention: probiotic fermented milk and current fermented milk. Duration of intervention: 2 months. The primary outcome or study outcoms: improvment of blood glucose level, lipid profile and hs-CRP level.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307092017N14
Registration date: 2013-09-07, 1392/06/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences & Tabriz Unversity
Expected recruitment start date
2011-04-18, 1390/01/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic fermented milk on lipid profile, blood glucose, and hs-CRP levels in diabetic patients.
Public title
Effect of probiotic fermented milk on lipid profile, blood glucose, and hs-CRP levels in diabetic patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: person with diabetes and aged between 30 to 60 years old. Exclusion criteria: not using cholesterol lowering drugs; not using anti inflammatory drugs; and not using insulin therapy.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There are two groups in this study. one group will consume probiotic fermented milk and other group will consume current fermented milk

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university of medical sciences- Research vice chancellor
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2011-04-18, 1390/01/29
Ethics committee reference number
9287

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
lipid profiles
Timepoint
before intervention, 2 months after intervention
Method of measurement
By Laboratory kit

2

Description
blood glucose level
Timepoint
before intervention, 2 months after intervention
Method of measurement
by Laboratory kit

3

Description
hs-CRP
Timepoint
before intervention- 2 months after intervention
Method of measurement
By Laboratory Kit

Secondary outcomes

empty

Intervention groups

1

Description
Probiotic fermented milk ( 600 ml/day) duration of intervention: 8 weeks
Category
Other

2

Description
Current fermented milk ( 600 ml/day) duration of intervention: 8 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Community support of patients with diabetes
Full name of responsible person
Dr. Majid Mobaseri
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Tabriz- Faculty of nutrition
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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

2

Sponsor
Name of organization / entity
Tabriz University
Full name of responsible person
Dr. Akabar Taghizadeh
Street address
faculty of agreculture
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University
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
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Nazila Farrin
Position
Ph.D student of nutrition sciences
Other areas of specialty/work
Street address
Tabriz- faculty of nutrition
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
nazilafarrin@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
MD. Ph.D of nutrition sciences
Other areas of specialty/work
Street address
Tabriz- Tabriz university of medical sciences, Faculty of nutrition
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Nazila Farrin
Position
Ph.D student of nutrition sciences
Other areas of specialty/work
Street address
Tabriz- Tabriz university of medical sciences, Faculty of nutrion
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
nazilafarrin@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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