Protocol summary

Study aim
The effect of pomegranate extract tablet on some of metabolic factor, hepatokines (fetuin A, FGF21), inflammatory biomarkers, anthropometric indices and grade of fatty liver in patients with non-alcoholic fatty Liver disease
Design
The present study is a simple randomized clinical trial on 50 subjects with nonalcholic fatty liver. In this study, individuals are divided into two groups of drugs and placebo. Randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block.
Settings and conduct
A double blind randomized clinical trial. Blinding on patients and researchers. 50 Patients with non alcoholic fatty liver into pomegranate extract tabley and placebo groups. The period of intervention:12 weeks.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age 18 to 65 years, Body mass index 29.4 to 40, Presence of non-alcoholic steathepatitis in ultrasonography with degree of steatosis higher than grade 1, Not having a special diet, The liver enzyme concentration greater than 1.5 times the highest normal up to a 5 times more than normal. Exclusion criteria: History of hepatitis, Other liver diseases, Gastrointestinal diseases, Cardiovascular Diseases, Anemia, Hospitalized patients, Kidney diseases, Endocrine disorders, Alcohol drinking, Smoking, Taking any medicine, insulin, hepatic steatosis drugs, Intravenous nutrition, Special diets, Taking vitamin supplements, Pregnancy or breastfeeding, Menopause. Weight loss surgery in the last year.
Intervention groups
Group 1: pomegranate extract tablet; Group 2: placebo
Main outcome variables
Anthropometry indices, liver enzymes, fasting blood sugar; fasting insulin; Insulin resistance; adiponectin; fetuin A; fibroblast growth factor 21; inflammation factors; blood pressure; degree of hepatic steatosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140107016123N14
Registration date: 2019-12-04, 1398/09/13
Registration timing: registered_while_recruiting

Last update: 2019-12-04, 1398/09/13
Update count: 0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pomegranate extract tablet on some of metabolic factor, hepatokines (fetuin A, FGF21), inflammatory biomarkers, anthropometric indices and grade of fatty liver in patients with non-alcoholic fatty Liver disease
Public title
The effect of pomegranate extract on non alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age:18 to 65 years old Body mass index 29.4 to 40 Presence of non-alcoholic steathepatitis in ultrasonography with degree of steatosis higher than grade 1 consent with collaboration in study Not taking any dietary supplements Not being on a special diet the liver enzyme serum level (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST)) 1.5 times greater than the highest normal up to a 5 times more than the highest level of normal range non diabetes
Exclusion criteria:
People with a history of hepatitis including A, B and C; Other liver diseases including autoimmune liver disease, liver transplantation, liver metabolic disease, Wilson's disease gastrointestinal diseases cardiovascular diseases anemia kidney diseases endocrine disorders (such as hypothyroidism or hyperthyroidism, Cushing's) having a history of drinking more than 10 grams per day in women and more than 20 grams per day in men smoking Taking any medicine, insulin, hepatic steatosis drugs getting intravenous nutrition getting special diets and taking vitamin supplements in the last three months pregnancy or lactating menopause weight loss surgery during the last year Unwillingness to cooperate
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a simple randomized clinical trial on subjects with nonalcholic fatty liver. In this study, individuals are divided into two groups of drugs and placebo.Randomization will done using quadratic block. Statistical software (Minitab) will use to perform randomized block.
Blinding (investigator's opinion)
Double blinded
Blinding description
To make this study double-blinded and keep the researchers and participants unaware of the taken tablets, before the intervention, the container of pomegranate extract and placebo were coded as A or B by a third person (non-researcher).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-10-12, 1398/07/20
Ethics committee reference number
IR.AJUMS.REC.1398.519

Health conditions studied

1

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

Primary outcomes

1

Description
Alanine aminotransferase
Timepoint
before intervention and after 12 weeks
Method of measurement
seum level

2

Description
Aspartate transaminase
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

3

Description
gamma glutamyl transferase
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

4

Description
alkaline phosphatase
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

5

Description
triglycerides
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

6

Description
total cholesterol
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

7

Description
Low density lipoprotein (LDL)
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

8

Description
High density lipoprotein (HDL)
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

9

Description
fasting blood sugar
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

10

Description
fasting insulin
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

11

Description
insulin resistance
Timepoint
before intervention and after 12 weeks
Method of measurement
405÷(insulin×glucose)=HOMA-IR ; Homeostatic model assessment

12

Description
Adiponectin
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

13

Description
Fetuin A
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

14

Description
fibroblast growth factor 21(FGF 21)
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

15

Description
total antioxidant capacity
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

16

Description
high sensitive C reactive protein (hs-CRP)
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

17

Description
interlukin-6(IL-6)
Timepoint
before intervention and after 12 weeks
Method of measurement
serum level

18

Description
weight
Timepoint
before intervention and after 12 weeks
Method of measurement
scale

19

Description
waist circumference
Timepoint
before intervention and after 12 weeks
Method of measurement
waist circumference in CM

20

Description
body mass index (BMI)
Timepoint
before intervention and after 12 weeks
Method of measurement
Ratio of weight (kg) to second power (in meters)

21

Description
Degree of hepatic steatosis
Timepoint
before intervention and after 12 weeks
Method of measurement
sonography

Secondary outcomes

1

Description
systolic blood pressure
Timepoint
before intervention and after 12 weeks
Method of measurement
Blood pressure monitor

2

Description
diastolic blood pressure
Timepoint
before intervention and after 12 weeks
Method of measurement
Blood pressure monitor

Intervention groups

1

Description
Intervention group: Pomegranate extract tablet 225 mg twice daily for 12 weeks
Category
Treatment - Other

2

Description
Control group: Placebo twice daily for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomieni Hospital
Full name of responsible person
Sima Jafarirad
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvas
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7543
Fax
+98 61 3336 7544
Email
sjafarirad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7543
Fax
+98 61 3336 7544
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7543
Email
sjafarirad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7543
Email
sjafarirad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Goodarzi
Position
Ph.D. condidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7543
Email
goodarzi121@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
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