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Effect of probiotics supplementation on blood profile on NAFLD patients

Protocol summary

Summary
Objective: the effect of probiotics on the blood parameters in patients with NAFLD. Inclusion criteria: patients with NAFLD; the age range was 18 to 65 years old. Exclusion criteria: patients with NAFLD that used supplemental probiotics of probiotic foods during last 3 monthes; also those used tobacco and alcohol; patients with cardiovascular diseases, chronic liver and kidney diseases, Wilson disease, Hemochromatosis; people with low immune system ability (autoimmune) and pregnant or lactating women. Population and sample size: 60 patients with NAFLD among people eligible to participate and referred to Baqiyatallah Research Center for Gastroenterology and Liver Disease. Intervention: these patients were divided to either an intervention group (receiving probiotic capsule) or placebo (receiving placebo) groups. After an overnight fasting, subjects referred for blood drawn. After this stage, blood samples tested. After 8 weeks of experiment, fasting blood samples were tested again. Baseline serum LDL-C, HDL-C, TG and total cholesterol, Fasting glucose, insulin, malondialdehyde, TAC, ALT,AST, TNF-a , and IL-6.

General information

Acronym
NAFLD ( Non Alchoholic Fatty Liver Disease )
IRCT registration information
IRCT registration number: IRCT2012122911920N1
Registration date: 2013-05-19, 1392/02/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-05-19, 1392/02/29
Registrant information
Name
Sepideh Abbaszadeh
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0153
Email address
abbaszadehs@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Science
Expected recruitment start date
2013-05-31, 1392/03/10
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotics supplementation on blood profile on NAFLD patients
Public title
Effect of probiotics on patients with NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with NAFLD; the age range was 18 to 65 years old. Exclusion criteria: patients with NAFLD that used supplemental probiotics of probiotic foods during last 3 monthes; also those used tobacco and alcohol; patients with cardiovascular diseases, chronic liver and kidney diseases, Wilson disease, Hemochromatosis; people with low immune system ability (autoimmune) and pregnant or lactating women.
Age
From 18 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
Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, South sheikh-Bahaei street, Mollasadra Avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-05-06, 1392/02/16
Ethics committee reference number
92/ج736

Health conditions studied

1

Description of health condition studied
Non Alchoholic Fatty Liver Disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Malodialdehyde (MDA)
Timepoint
Before and after Intervention
Method of measurement
ELISA

2

Description
TAC
Timepoint
Before and after Intervention
Method of measurement
ELISA

3

Description
Serum Insulin Levels
Timepoint
Before and After Intervention
Method of measurement
ELISA

4

Description
IL-6
Timepoint
Before and After Intervention
Method of measurement
ELISA

5

Description
Serum Glucose
Timepoint
Before and after Intervention
Method of measurement
Autoanalyzer

6

Description
Lipid Profile ( Tg,Total Chol, LDL-C, HDL-C )
Timepoint
Before and After Intervention
Method of measurement
Autoanalyzer

7

Description
TNF-α
Timepoint
Before and after Intervention
Method of measurement
ELISA

8

Description
oxLDL
Timepoint
Before and after Intervention
Method of measurement
ELISA

9

Description
ALT
Timepoint
Before and after Intervention
Method of measurement
autoanalyzer

10

Description
AST
Timepoint
Before and after Intervention
Method of measurement
autoanalyzer

Secondary outcomes

empty

Intervention groups

1

Description
Control: Placebo Group receiving capsules once daily, for eight weeks.
Category
Treatment - Drugs

2

Description
Intervention: patients in the treatment group received probiotic capsules (Lactobacillus, Bifidobacter, Streptococcus) once daily for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
ms Rostami
Street address
n. 178 Shadab Square, Sepahbod Gharani Avenue, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Dr Gashtasb Aghasinejad
Street address
financial Deputy of Baqiyatallah University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Science
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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Sepideh Abbaszadeh
Position
Food Safety
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
Email
dr_s_abbaszadeh@yahoo.comabbaszadeh@bmsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Karim parastouei
Position
PhD
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science
City
Tehran
Postal code
Phone
+98 21 8804 0153
Fax
Email
parastouei@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Sepideh Abbaszadeh
Position
Baqiyatallah University of Medical Science
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, Tehran, Iran
City
Tehran
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
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