Protocol summary

Summary
Objectives: This study was designed to determine impact of Probiotic yogurt on blood glucose and lipid profiles. Inclusion criteria: Type 2 diabetes; 30-65 years; both sexes, who taking Metformin and Glibenclamide, with no renal diseases (Cr <0.4 mg/dl),high blood pressure (BP<200/110 mmHg), liver diseases. Exclusion criteria: No insulin injection; any changes in using medication; smoking; lactose intolerance; thyroid dysfunction; chronic inflammatory diseases; cardio-vascular disease; pregnancy; breast feeding; and having any weight loose or weight gain regimes. Target population were diabetic type 2 patients, sixty patients randomly divided to two intervention and control groups and respectively received 100g of probiotic yogurt (containing Lactobacillus Acidophilus and Bifidobacterium Lactis) and 100g conventional yogurt twice a day for 8 weeks in 2006.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030726954N1
Registration date: 2016-03-30, 1395/01/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-30, 1395/01/11
Registrant information
Name
Zahra Tazakori
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 8005
Email address
z.tazakori@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Proposal of Ardabil University of Medical Sciences
Expected recruitment start date
2006-03-21, 1385/01/01
Expected recruitment end date
2007-02-20, 1385/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic yogurt on blood glucose and lipid profiles serum of type 2 diabetes.
Public title
Probiotic yogurt effect on diabetes control
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Type 2 diabetes; 30-65 years; both sexes, who taking Metformin and Glibenclamide, with no renal diseases (Cr <0.4 mg/dl),high blood pressure (BP<200/110 mmHg), liver diseases. Exclusion criteria: No insulin injection; any changes in using medication; smoking; lactose intolerance; thyroid dysfunction; chronic inflammatory diseases; cardio-vascular disease; pregnancy; breast feeding; and having any weight loose or weight gain regimes.
Age
From 30 years old to 65 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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Janbazan Square, across from Lake Shorabil, Ardabil University of Medical Sciences
City
Ardabil
Postal code
5618953141
Approval date
2016-03-15, 1394/12/25
Ethics committee reference number
IR.ARUMS.REC.1394.143

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
blood glucose ( FBS ) , blood glucose 2 hours after gloucose consumption
Timepoint
before and after study
Method of measurement
photometry method pars amazon kit

2

Description
LDL
Timepoint
before and after study
Method of measurement
Fridval formula

3

Description
HDL,TG, total cholesterol
Timepoint
before and after study
Method of measurement
by photometry method pars amazon kit

Secondary outcomes

1

Description
24 hours recall
Timepoint
before and after
Method of measurement
24 hours recall intake wrere checked by interview

Intervention groups

1

Description
Interventionl group received probiotic (100gr) twice a day for 8 weeks
Category
Prevention

2

Description
control group received conventional yogurt (100gr) twice a day for 8 weeks
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini diabetes clinic of Ardabil University of Medical Sciences
Full name of responsible person
Zahra Tazakori
Street address
Iran
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahram Habibzadeh
Street address
Iran
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Zahra Tazakori
Position
PhD of Nursing and faculty member
Other areas of specialty/work
Street address
Iran
City
Ardabil
Postal code
Phone
+98 45 3352 2083
Fax
Email
z.tazakori@arums.ac.irtazakori@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Zahra Tazakori
Position
PhD
Other areas of specialty/work
Street address
Iran
City
Ardabil
Postal code
Phone
+98 45 3352 2083
Fax
Email
z.tazakori@arums.ac.irtazakori@gmail.com
Web page address
www.arums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Zahra Tazakori
Position
PhD
Other areas of specialty/work
Street address
Iran
City
Ardabil
Postal code
Phone
00
Fax
Email
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
Loading...