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Assessment of the Ellagic acid supplementation effect on lipid profile, liver enzymes, oxidative stress status and inflammatory factors in patients with non-alcoholic fatty liver disease: double-blind randomized clinical trial

Protocol summary

Study aim
Determination of ellagic acid supplement effect in in patients with non-alcoholic fatty liver disease
Design
In this study, 44 patients with non-alcoholic fatty liver disease who are eligible to enter the study are selected. Participants are randomly divided into intervention and control groups and each participant will be assigned a code.
Settings and conduct
The aim of this study is to evaluate the ellagic acid supplement as a randomized, double-blind clinical trial on patients with non-alcoholic fatty liver disease referring to the specialized department of the hospital of Qazvin University of Medical Sciences. People with non-alcoholic fatty liver disease after the introduction by a specialist, counselor for this project, will be randomly divided into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-55 years old patient with non-alcoholic fatty liver, confirmation of non-alcoholic fatty liver with liver ultrasound, having a body mass index less than 30, consent signed by the patient. Exclusion criteria: pregnancy, lactation, infectious disease, inflammatory disease, Cushing's syndrome, adrenal gland tumor, hypothyroidism, diabetes, and cancer, taking antioxidant supplements in the last three months, taking medication in the last three months including glucocorticoids drugs, lipid-lowering drugs, and weight-loss drugs.
Intervention groups
Intervention group: the group receiving ellagic acid (180 mg daily) Control group: placebo group
Main outcome variables
Fasting blood sugar, insulin resistance, lipid profile, liver enzymes, oxidative stress indices, inflammatory factors and adiponectin hormone

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141025019669N21
Registration date: 2022-01-23, 1400/11/03
Registration timing: registered_while_recruiting

Last update: 2022-01-23, 1400/11/03
Update count: 0
Registration date
2022-01-23, 1400/11/03
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Ellagic acid supplementation effect on lipid profile, liver enzymes, oxidative stress status and inflammatory factors in patients with non-alcoholic fatty liver disease: double-blind randomized clinical trial
Public title
Ellagic acid supplementation in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-55 years old patient with non-alcoholic fatty liver, confirmation of non-alcoholic fatty liver with liver ultrasound Having a body mass index of less than 30 A consent signed by the patient.
Exclusion criteria:
Pregnancy and lactation Infectious disease, inflammatory disease, Cushing's syndrome, adrenal gland tumor, hypothyroidism, diabetes, and cancer. Taking antioxidant supplements in the last three months Taking medication in the last three months including glucocorticoids drugs, lipid-lowering drugs, and weight-loss drugs.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done randomly using the lottery method. Each patient will receive a number or code, and then we will write the numbers on pieces of paper. We will then place the pieces of paper in a container and select the samples according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo will be placed in similar containers and encoded by someone except the investigator, so patients and the investigator will be blinded to medicine and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University Of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.QUMS.REC.1400.362

Health conditions studied

1

Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

2

Description
Insulin
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

3

Description
Insulin resistance
Timepoint
Before the intervention and after the intervention
Method of measurement
Using the formula

4

Description
Total antioxidant capacity
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

5

Description
Malondialdehyde
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

6

Description
Lipid profile
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

7

Description
Liver enzymes
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

8

Description
Inflammatory factors
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

9

Description
Adiponectin hormone
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Ellagic acid, a capsule 180 mg per daily for two months, Manufacturer: Supplement Spot
Category
Treatment - Drugs

2

Description
Control group: A daily placebo capsule containing wheat flour for two months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Hossein Khadem Haghighian
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mirhashemi
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after people are unrecognizable
When the data will become available and for how long
After completing the study and publishing the article
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is nothing wrong with using the data as long as the source of the data is mentioned.
From where data/document is obtainable
By contacting the email address of a person responsible for general inquiries khademnut@yahoo.com
What processes are involved for a request to access data/document
After consulting with the research team, the data will be provided to the applicant, which will probably be a one-month process.
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