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Effect of probiotic supplementation on glycemic, inflammatory indices, blood lipids and body composition in prediabetic patients

Protocol summary

Summary
60 prediabetic patients admitted to the Endocrine and Metabolism Research Center-Isfahan University of Medical Sciences will be included in the study, after completing consent forms, the subjects will be randomly assigned to either intervention or placebo groups. Demographic information and laboratory results will be designed for each subject, before and after intervention. Dietary measurements will be performed by using food frequency questionnaire and 24 hour dietary recall. Height will be measured by stadiometer with 0.5 cm precision in normal standing position. Body composition (including weight, lean body mass, soft lean mass, total body water, body fat, protein, mineral,body mass index, abdominal circumfrence, waist to hip ratio, and basal metabolic rate) will be assessed by Body Composition Analyzer, while the subject is wearing light clothes with bare feet and hands. Subjects will receive either probiotics or placebo once a day for 8 weeks. We will call or text subjects once a week to remind them to take the capsules regularly. An expert dietition will keep in touch with subjects to solve any problems if there is some.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022411763N5
Registration date: 2013-08-06, 1392/05/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-06, 1392/05/15
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Isfahan University of Medical Sciences
Expected recruitment start date
2012-12-01, 1391/09/11
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of probiotic supplementation on glycemic, inflammatory indices, blood lipids and body composition in prediabetic patients
Public title
probiotics and prediabetes
Purpose
Prevention
Inclusion/Exclusion criteria
all prediabetic patients at the age range of 25 to 65 years old with fsting plasma glucose between 100 and 125 mg/dl and glucose tolerance test between 140 to 200 mg/dl are included in the study, study subjects must have an stesdy state of glycemic and lipid control and drug usage. patients with chronic hepatic, renal, heart and acute inflammatory diseases are not included in the study. patients who have allergic responses to probiotics or those who want to give up following the study or those who have not taken their probiotics will be excluded from the study.
Age
From 25 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
Isfahan Regional Bioethics Committee
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Postal code
81745319
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
329157

Health conditions studied

1

Description of health condition studied
prediabetes
ICD-10 code
E-11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
fasting blood glucose
Timepoint
the first day of the study and the last day of 8th week
Method of measurement
Colorimetry

2

Description
glycated hemoglobin(HbA1C)
Timepoint
the first day of the study and the last day of 8th week
Method of measurement
Ion exchange chromatography

3

Description
Total serum cholestrol
Timepoint
the first day of the study and the last day of 8th week
Method of measurement
Enzymatic assay with autoanalyser

4

Description
Serum triglycerides
Timepoint
the first day of the study and the last day of 8th week
Method of measurement
Enzymatic assay with autoanalyser

5

Description
Serum low density lipoprotein
Timepoint
the first day of the study and the last day of 8th week
Method of measurement
Enzymatic assay with autoanalyser

6

Description
Serum High density lipoprotein
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Enzymatic assay with autoanalyser

7

Description
Erythrocyte sedimentation rate
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Instrumental analaysis method

8

Description
High sensitive C- Reactive Protein
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Turbidimetric Method

Secondary outcomes

1

Description
Height
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Stadiometer

2

Description
Body compisition
Timepoint
the first day of the study and the last day of 8th week
Method of measurement
BIA method

3

Description
Blood pressure
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Presure indicator

Intervention groups

1

Description
Probiotic Familact, 500 miligrams capsules, once a day (with lunch), for 60 days.
Category
Treatment - Drugs

2

Description
Placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
The endocrine and metabolism research center, Isfahan University of Medical Sciences.
Full name of responsible person
Dr.Gholamreza Askari
Street address
Department of Community Nutrition, School of Nutrition and Food sciences, Isfahan University of Medical Sciences
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Peyman.Adibi
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

2

Sponsor
Name of organization / entity
Research Deputy of Isfahan University of Medical Sciences
Full name of responsible person
Doctor Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of 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
Full name of responsible person
Sepideh.Mahboobi
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2110
Fax
Email
sepidmahboobi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Ph.D of nutrition, Assistant Professor
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2110
Fax
Email
askari@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
Sepideh.Mahboobi
Position
MSc student of Nutrition
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2110
Fax
Email
sepidmahboobi@gmail.com
Web page address

Sharing plan

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