Protocol summary

Summary
The present study aiming to evaluate the effect of synbiotic yogurt consumption on hepatic echogenisity, liver enzymes, lipid profile, glycemic status, blood pressure, body composition, oxidative stress markers, glucagon like peptide-2, and complement C1q/tumor necrosis factor-α related protein-5 in patients with non alcoholic fatty liver disease. This study is a parallel randomized controlled clinical trial. 102 Patients will be randomly allocated into three groups, including two intervention groups and the control group. Exclusion criteria includes alcohol use, viral hepatitis, hepatocellular carcinoma, other causes of chronic liver disease, diabetes mellitus, untreated hypothyroidism, psychiatric disorder, kidney disease, pregnancy and lactation. The intervention groups will consume 300 grams per day of synbiotic or conventional yogurt in addition to usual treatment and control group will receive usual treatment for 24 weeks. Dietary assessment, anthropometric measurements, blood pressure, physical activity questionnaire and fasting blood sampling will be done at the weeks 0, 8, 16 and 24 of the trial and the results will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020932417N2
Registration date: 2017-03-12, 1395/12/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-12, 1395/12/22
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 2375
Email address
alizadeh.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2016-07-30, 1395/05/09
Expected recruitment end date
2016-08-31, 1395/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic yogurt consumption on liver echogenicity and markers of liver function in patients with non alcoholic fatty liver disease
Public title
The effect of synbiotic yogurt on non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: contracting non alcoholic fatty liver disease and age of between 18 and 75. Exclusion criteria: alcohol use; viral hepatitis; hepatocellular carcinoma; other causes of chronic liver disease; diabetes mellitus; untreated hypothyroidism; psychiatric disorder; kidney disease; pregnancy; and lactation.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Orjans valley,Resalat boulevard
City
Urmia
Postal code
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
umsu.rec.1395.113

Health conditions studied

1

Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Fat free mass
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
BIA, percentage

2

Description
Fat mass
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
BIA, percentage

3

Description
Hepatic steatosis
Timepoint
Before Intervention and six months after Intervention
Method of measurement
Ultrasonography

4

Description
HDL cholesterol
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, mg/dl

5

Description
Triglyceride
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, mg/dl

6

Description
LDL cholesterol
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, mg/dl

7

Description
Total cholesterol
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, mg/dl

8

Description
Fasting blood sugar
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, mg/dl

9

Description
Serum Insulin
Timepoint
Before Intervention and six months after Intervention
Method of measurement
Radioimmunoassay, µU/ml

10

Description
Alanine Aminotransferase
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, IU/Lit

11

Description
Aspartate transaminase
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, IU/Lit

12

Description
Alkaline phosphatase
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, IU/Lit

13

Description
Gamma Glutamyl transferase
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Enzymatic method, IU/Lit

14

Description
Total antioxidant capacity
Timepoint
Before Intervention and six months after Intervention
Method of measurement
ELISA method, µM

15

Description
Total oxidant status
Timepoint
Before Intervention and six months after Intervention
Method of measurement
Enzymatic method, µM

16

Description
Complement C1q/tumor necrosis factor-α related protein-5
Timepoint
Before Intervention and six months after Intervention
Method of measurement
ELISA method, mg

17

Description
glucagon like peptide-2
Timepoint
Before Intervention and six months after Intervention
Method of measurement
ELIZA method, pg/ml

18

Description
Systolic blood pressure
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Mercury sphygmomanometer, mmHg

19

Description
Diastolic blood pressure
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Mercury sphygmomanometer, mmHg

20

Description
Weight
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
Scale, kg

21

Description
Height
Timepoint
Before intervention
Method of measurement
Stadiometer, mm

22

Description
Body mass index
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
weight (kg) / [height (m)]2, kg/m2

23

Description
Carbohydrate Intake
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
gr/day

24

Description
Protein Intake
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
gr/day

25

Description
Fat Intake
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
gr/day

26

Description
Energy Intake
Timepoint
At weeks 0, 8, 16 and 24
Method of measurement
kcal/day

Secondary outcomes

empty

Intervention groups

1

Description
The second intervention group will be consume 300 grams per day conventional yogurt in addition to usual treatment for six months.
Category
Treatment - Other

2

Description
The first intervention group will be consume 300 grams per day synbiotic yogurt in addition to usual treatment for six months.
Category
Treatment - Other

3

Description
The control group will receive usual treatment for six months.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sahand clinic
Full name of responsible person
Dr. Kamran Shateri
Street address
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
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 of Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Prof
Other areas of specialty/work
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Phone
+98 44 3275 2375
Fax
Email
alizadeh.m@umsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Prof
Other areas of specialty/work
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Phone
+98 44 3275 2375
Fax
Email
alizadeh.m@umsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Uremia University of Medical Sciences
Full name of responsible person
Farnush Bakhshi Moghadam
Position
MS Student of nutrition
Other areas of specialty/work
Street address
City
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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