Evaluation of the effectiveness of ellagic acid on liver steatosis in patients with non-alcoholic fatty liver disease
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 60 patients; randomization using Randomaization.com.
Settings and conduct
This study will perform in the clinics of Mashhad University of Medical Sciences. Patients are randomly assigned to Ellagic acid and placebo groups. Patients and the main researcher are unaware of the group assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 30-65 years old; body composition index between 25-35; diagnosis of liver steatosis by two-dimensional elastography (grade 2 and above); fatty liver patients with grade F0 and F1.
Exclusion criteria: viral hepatitis (especially hepatitis C); alcoholic fatty liver or consumption of alcohol; diseases such as Wilson's disease, hemochromatosis, celiac disease, cirrhosis, biliary obstruction and primary biliary cirrhosis; special nutritional conditions such as starvation, fasting, and intravenous feeding; smoker; breastfeeding or pregnancy; history of hypersensitivity to pomegranate and its products; diabetes; taking any kind of herbal supplements; fatty liver patients with grade F2, F3, F4.
Intervention groups
Intervention group: receiving Ellagic acid capsules 200 mg once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy.
Placebo group: receiving placebo capsules of the same shape and size once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy.
Main outcome variables
The amount of hepatic steatosis is measured by elastography at the beginning and end of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038199N16
Registration date:2023-05-01, 1402/02/11
Registration timing:registered_while_recruiting
Last update:2023-05-01, 1402/02/11
Update count:0
Registration date
2023-05-01, 1402/02/11
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of ellagic acid on liver steatosis in patients with non-alcoholic fatty liver disease
Public title
Evaluation of the effectiveness of ellagic acid on patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-65 years old
Body composition index between 25-35
Diagnosis of liver steatosis by two-dimensional elastography (grade 2 and above)
Fatty liver patients with grade F0 and F1
Exclusion criteria:
Viral hepatitis (especially hepatitis C)
Alcoholic fatty liver or consumption of alcohol
Diseases such as Wilson's disease, hemochromatosis, celiac disease, cirrhosis, biliary obstruction and primary biliary cirrhosis
Special nutritional conditions such as starvation, fasting, and intravenous feeding
Smoker
Breastfeeding or pregnancy
History of hypersensitivity to pomegranate and its products
Diabetes
Taking any kind of herbal supplements
Fatty liver patients with grade F2, F3, F4
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 15 blocks according to the sample size of 60. Then random numbers between 1 and 15 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-03-07, 1401/12/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.712
Health conditions studied
1
Description of health condition studied
Patients with 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
Hepatic steatosis
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Elastography
Secondary outcomes
1
Description
Hepatic fibrosis
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Elastography
2
Description
Changes in lipid profile
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
3
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
4
Description
Fasting insulin
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
5
Description
Uric acid
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
6
Description
Serum Creatinine
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
7
Description
Changes in Interleukin-6 levels
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
8
Description
Changes in hs-CRP serum level
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
9
Description
Changes in ALT level
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
10
Description
Changes in AST level
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
11
Description
Changes in ALP level
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
12
Description
Changes in GGT level
Timepoint
At the beginning of the study and after 2 months of treatment
Method of measurement
Laboratory kit
13
Description
Physical activity score
Timepoint
At the beginning of the study and after 1 and 2 months of treatment
Method of measurement
IPAQ questionnaire
14
Description
Body weight
Timepoint
At the beginning of the study and after 1 and 2 months of treatment
Method of measurement
A scale with an accuracy of 100 grams
15
Description
Body Composition
Timepoint
At the beginning of the study and after 1 and 2 months of treatment
Method of measurement
BIA
Intervention groups
1
Description
Intervention group: receiving Ellagic acid capsules 200 mg once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy.
Category
Treatment - Drugs
2
Description
Control group: receiving placebo capsules of the same shape and size once a day with one glass of water for 60 days (two months) along with a hypocaloric diet with a reduction of 500 kcal of energy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Reza Askari
Street address
Mashhad University of Medical Science, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
askariv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayour-Mobarhan
Street address
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assistant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv941@mums.ac.ir
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