1. Home
  2. Approved trials
  3. » فارسی

Effect of kefir drink on hepatic enzymes, lipid profiles, glycemic indices,inflammation, oxidative stress, anthropometric factors and blood pressure in patients with non-alcoholic fatty liver disease.

Protocol summary

Study aim
the aim of this study were to evaluate the effects of kefir drinks on non-alcoholic fatty liver disease.
Design
randomised, parallel group trial with with control and intervention group
Settings and conduct
select non-alcoholic fatty liver patients based on inclusion and exclusion criteria that refered to Motahhari clinic. then completed consent and other questionnaires for participants.finally patients settled on either groups based on randomisation. Patients will not be aware of the two groups being studied.
Participants/Inclusion and exclusion criteria
inclusion criteria: age 18 to 65 years, body mass index more than 25, ALT more than 19 and 30 for males and women respectively,... exclusion criteria: presence of another type of liver disease, kidney, cardiovascular and thyroid disease, weight loss more than 3 kg within previous 3 month, using alcohol and ...
Intervention groups
control group: receive balanced diet which 500 Kilo calorie lower than estimated energy requirements. intervention group: receive balanced diet + 2 glasses kefir drink daily for 8 weeks.
Main outcome variables
altration hepatic enzymes, weight, lipid profiles, blood pressure, inflammation and oxidative stress.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170916036204N6
Registration date: 2018-08-03, 1397/05/12
Registration timing: registered_while_recruiting

Last update: 2018-08-03, 1397/05/12
Update count: 0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Najmeh Hejazi
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1005
Email address
nhejazi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of kefir drink on hepatic enzymes, lipid profiles, glycemic indices,inflammation, oxidative stress, anthropometric factors and blood pressure in patients with non-alcoholic fatty liver disease.
Public title
The effect of kefir drink on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
grade 1,2 & 3 fatty liver, new fatty liver diagnosed patients, and fatty liver confirmed by physician. Alt>30 in males and ALt>19 in females. age: 18-65 BMI>25 controlled Diabetes and lipid profile.
Exclusion criteria:
presence of another type of liver disease, cirrhosis, hepatitis B and C, cardiovascular and kidney disease, autoimmune, hypothyroidism, wilson, cystic fibrosis, Deficiency of alpha-1-antitrypsin 1, inflammatory bowel disease and hemochromatosis. using alcohol taking nutritional and probiotic supplements within the previous 6 weeks. having weight loss more than 3 Kg within 3 month ago participating in other trials in the last 6 month being pregnant or breast feeding do not want to participate in this trial.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization, individual, Random allocation software, 20 randomization sequence in permuted blocks of size four
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand street, Before Namazi square, Centeral department of Shiraz University of Medical Sciences.
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2018-04-08, 1397/01/19
Ethics committee reference number
IR.sums.REC.1397.107

Health conditions studied

1

Description of health condition studied
non-alcoholic fatty liver disease
ICD-10 code
k77
ICD-10 code description
non-alcoholic, fatty liver disease

Primary outcomes

1

Description
Alanine aminotransferase
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
ALT kit

2

Description
Aspartate transaminase
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
AST kit

3

Description
weight
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
seca scale

Secondary outcomes

1

Description
blood pressure
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
Mercury barometric device

Intervention groups

1

Description
Intervention group:received diet therapy + kefir drink 2 glasses(500 ml) every day for 8 weeks. Kefir will be purchased from Pegah Fars Factory.
Category
Treatment - Devices

2

Description
Control group: received diet that 500 kilo calorie less than energy requirements for 8 weeks.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari clinic
Full name of responsible person
Najmeh Hejazi
Street address
Shiraz University of Medical Sciences, Namazi squre
City
Shiraz
Province
Fars
Postal code
7166776770
Phone
+98 71 3612 1000
Email
nhejazi@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
ِِDoctor seyed Basir hashemi
Street address
shiraz university of medical sciences-vice chancellor for research affairs Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nadia Razmjooei
Position
Master of science in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Sceinces, fatholmobin alley, Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
nadiarazmjoee@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Hejazi
Position
PHD in nutrition sciences, assistant professor of nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Sciences, Fatholmobin alley, Razi blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 987137251001
Email
nhejazi@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nadia Razmjooei
Position
master of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition and Food Sciences, Fatholmobin alley, Razi blvd
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 987137251001
Email
nadiarazmjoee@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...