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Effects of Symbiotic on inflammatory markers, liver function, lipid profile, sonographic findings and body composition in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)

Protocol summary

Summary
This study is a double blind randomized clinical trial. The goal of our study is to determine the effects of symbiotic on inflammatory markers, liver function, lipid profile, sonographic findings and body composition in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). A sample of 80 NAFLD patients aged 18-60 years will be enrolled in the study. The exclusion criteria are other chronic liver diseases, Inflammatory Bowel Diseases, Diabetes Mellitus, Cancer, consumption of some drugs or supplements. The patients by Block Randomization for age, sex, Body Mass Index (BMI) and Livergol or Metformin consumption, will be randomized to one of the two treatment and control groups. Patients in the first group will be treated with one tablet of synbiotic supplement contain 500 mg of seven Probiotic bacteria species and Fructooligosaccharides per day and control group will be treated with one placebo tablet per day. Physical activity and dietary recommendation will be given to both groups. The intervention will continue for 8 weeks. Liver Ultrasonography, routine liver tests, lipid profile, inflammatory markers and body composition will be evaluated on baseline and again after the intervention. Dietary intake and physical activity status will be determined by dietary record and physical activity record on the end of weeks 2, 4 and 6.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122811763N15
Registration date: 2014-01-02, 1392/10/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-01-02, 1392/10/12
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
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-01-10, 1392/10/20
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of Symbiotic on inflammatory markers, liver function, lipid profile, sonographic findings and body composition in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
Public title
Effect of Symbiotic on Non-Alcoholic Fatty Liver Disease (NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:aged 18-60 years; confirmation of NAFLD with Ultrasonography and increased levels of Ast and Alt; desire to participate in the study. Exclusion criteria: organ transplantation; presence of pregnancy and lactation; suffering from Wilson disease; chronic liver diseases unless NAFLD; Diabetes Mellitus; Cancer; antibiotics therapy; Receiving Oral Contraceptive Pill (OCP); drugs such as corticosteroids, Amiodarone, Tamoxifen, Cyclins, Perhexiline, Methotrexate and Hydralazine; Receiving of vitamin-mineral and omega-3 Supplements during the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study will be a double blind clinical trial. The researcher and the patients will not know that each patient will be in which group, treatment or control. The supplements and placebo tablets will be coded as A and B in similar packets by a person that will be unaware from goals of the study.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hearjarib St. Azadi Square
City
Isfahan
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
392326

Health conditions studied

1

Description of health condition studied
NAFLD
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver

Primary outcomes

1

Description
Fatty liver grade
Timepoint
before and after the intervention
Method of measurement
Ultrasonography

2

Description
Alt_Ast
Timepoint
before and after the intervention
Method of measurement
by laboratory analysis (blood tests)

3

Description
lipid profiles
Timepoint
before and after the intervention
Method of measurement
by laboratory analysis (enzymatic)

4

Description
inflammatory markers
Timepoint
before and after the intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)

5

Description
body composition
Timepoint
before and after the intervention
Method of measurement
Bioelectrical Impedance Assessment

Secondary outcomes

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Intervention groups

1

Description
Daily oral consumption of Symbiotic supplement produced by Zist takhmir company with Familact commercial name contain 500 mg of seven Probiotic bacteria species and Fructooligosaccharides with below composition for two months: Lactobacillus Casei, Lactobacillus Acidopholus, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium Breve, Bifidobacterium Longum, Streptococcus Thermophiles and giving physical activity and dietary recommendation about NAFLD to patients at the baseline
Category
Treatment - Drugs

2

Description
Daily Oral consumption of one tablet /day of placebo contain starch for two months and dietary recommendation about NAFLD to patients at the baseline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Endocrinology and Metabolism Research Center
Full name of responsible person
Atefe Asgharian
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
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
Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hearjarib St. Azadi Square
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
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
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Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Atefe Asgharian
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 Isfahan
City
Isfahan
Postal code
Phone
+98 31 1222 4458
Fax
Email
Asgharian.Atefe@yahoo.com; Asgharian.Atefe@gmail.com; Asgharian@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
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 Isfahan
City
Isfahan
Postal code
Phone
+98 31 1335 9090
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
Atefe Asgharian
Position
MSc 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
00
Fax
Email
Web page address

Sharing plan

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