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Effects of pomegranate peel dry extract supplementation on lipid profile, inflammatory and oxidative stress factors and nutritional status in patients with non-alcoholic fatty liver: A randomized clinical trial

Protocol summary

Study aim
Determination of the effect of supplementation with dry pomegranate peel extract on lipid profile, inflammatory markers and oxidative stress and nutritional status and hepatic steatosis in patients with NAFLD
Design
This study is a double-blind RCT that investigates the effect of supplementation with dry pomegranate peel extract for eight weeks at daily dose of 1500 (two capsules of 750 mg) on lipid profile, inflammatory markers and oxidative stress and nutritional status and liver fibrosis and steatosis status in NAFLD patients. Study groups: intervention and control (each n = 27).
Settings and conduct
Demographic information and medical history and anthropometric indices, BP and body composition (BIA), three-day food recall and IPAQ will be measured before, between and after the study. 5 cc of blood is taken (before & after the intervention) after 12-hour fasting, to evaluate laboratory indicators. All patients will be given hypocaloric diet. Mediterranean diet recommendations and physical activity will be given. At the end, changes in the status of steatosis and liver fibrosis in patients will be assessed.
Participants/Inclusion and exclusion criteria
Inclusion: 18 to 65 years, diagnosis of hepatic steatosis, filling out the consent form exclusion: pregnancy, lactation, morbidobesity, history of alcohol consumption or hepatotoxic drugs, any immunodeficiency disorder, HIV, liver or kidney failure, other liver diseases, history of FA, bariatric surgery
Intervention groups
Intervention group: lifestyle interventions (diet therapy + PA), supplementation of dry extract of pomegranate peel with 2 capsules each having 750 mg daily for 8 weeks.
Main outcome variables
Assessment of anthropometric indices, body composition, serum concentration of MDA, SOD, GPX, TC, HDL-C, LDL-C, TG, FBS and insulin, ALT, ALP, AST, IL6 and CRP and 3-day food recall, IPAQ and steatosis and hepatic fibrosis status.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210726051988N1
Registration date: 2021-09-14, 1400/06/23
Registration timing: prospective

Last update: 2021-09-14, 1400/06/23
Update count: 0
Registration date
2021-09-14, 1400/06/23
Registrant information
Name
Hanieh Barghchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 4558
Email address
barghchihn981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
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
Effects of pomegranate peel dry extract supplementation on lipid profile, inflammatory and oxidative stress factors and nutritional status in patients with non-alcoholic fatty liver: A randomized clinical trial
Public title
Effects of pomegranate peel dry extract supplementation on non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 years old Detection of hepatic steatosis by two-dimensional elastography device Filling out the informed consent form by the patient
Exclusion criteria:
Pregnancy and lactation Morbid obesity (BMI > 40) Alcohol consumption history (more than 20 grams per day for women and more than 30 grams per day for men), Having any type of immunodeficiency disorder, including: autoimmune disorders, cancer, human immunodeficiency virus (HIV) Hepatic or renal insufficiency, other liver diseases such as hepatitis, alcoholic fatty liver consumption of hepatotoxic drugs such as sodium valproate History of food allergy to pomegranate and herbal supplements History of bariatric surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
stratified randomization by sealed envelops: Randomization of samples to the intervention or control group is done based on blocks classified according to the degree of disease and sex. In this way, for example: man-grade one, woman-grade one, man-grade two, woman-grade two, man-grade three, woman-grade three, with sealed envelopes. An attempt is made to assign an equal number from each class to the intervention and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, investigator and data collectors, outcome assessors will be blinded.
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 science
Street address
Nutrition department, Faculty of medicine Mashhad University of Medical Sciences (MUMS), Azadi square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-08-28, 1400/06/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.195

Health conditions studied

1

Description of health condition studied
non alcoholic fatty liver- hepatic steatosis and fibrosis- pomegranate peel
ICD-10 code
K76.0
ICD-10 code description
Fatty (Chang of) liver, not elsewhere classified, Nonalcoholic fatty liver disease

Primary outcomes

1

Description
hepatic steatosis and fibrosis
Timepoint
before and at the end of the study
Method of measurement
Two-dimensional elastography device

Secondary outcomes

1

Description
Measurement of anthropometric indices (height, weight, body mass index)
Timepoint
Before, in the middle and at the end of the study
Method of measurement
Scales with an accuracy of 100 grams, meters,

2

Description
Measurement of body composition (percentage of adipose and lean tissue) by BIA device
Timepoint
Before, in the middle and at the end of the study
Method of measurement
BIA

3

Description
Measurement of serum concentrations of oxidative stress indicators including malondialdehyde, superoxide dismutase, glutathione peroxidase,
Timepoint
Before and at the end of the study
Method of measurement
Laboratory methods

4

Description
Evaluation of IPAQ physical activity questionnaire and three-day food recall
Timepoint
Before, in the middle and at the end of the study
Method of measurement
statistical methods

5

Description
Measurement of serum concentrations of lipid profiles including TC, HDL-C, LDL-C and TG,
Timepoint
Before and at the end of the study
Method of measurement
Laboratory methods

6

Description
Measurement of serum concentrations of fasting blood glucose and insulin,
Timepoint
Before and at the end of the study
Method of measurement
Laboratory methods

7

Description
Measurement of serum concentrations of hepatic profiles including ALT, ALP and AST,
Timepoint
Before and at the end of the study
Method of measurement
Laboratory methods

8

Description
Measurement of serum concentrations of inflammatory markers including interleukin 6 and reactive protein C
Timepoint
Before and at the end of the study
Method of measurement
Laboratory methods

Intervention groups

1

Description
In the intervention group, in addition to lifestyle interventions (diet therapy + physical activity), supplementation of dry extract of pomegranate peel with a dose of 1500 mg is performed for 8 weeks. Each capsule containing 750 mg of dry pomegranate peel extract is given daily with two main meals (breakfast and dinner) for 8 weeks.
Category
Treatment - Drugs

2

Description
In the control group, in addition to lifestyle interventions (diet + physical activity), patients received two capsules containing 750 mg placebo every day for 8 weeks with the same characteristics in terms of shape, smell, color, etc., along with two main meals (breakfast and Dinner) for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital Specialized Clinic
Full name of responsible person
Dr. Ladan Goshayeshi, Dr. Mohsen Nematy
Street address
Imam Reza Hospital Specialized Clinic- Imam Reza square- Mashhad- Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
barghchihn981@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad university of medical sciense- Azadi Square- Mashhad- Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
barghchihn981@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
Hanieh Barghchi
Position
MSc student of clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Science,Azadi Square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
barghchihn981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hanieh Barghchi
Position
MSc student of clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Science,Azadi Square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
barghchihn981@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hanieh Barghchi
Position
MSc student of clinical nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Science,Azadi Square, Mashhad City, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
barghchihn981@mums.ac.ir

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
Yes - There is 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
I will inform at the end of the study.
When the data will become available and for how long
I will inform at the end of the study.
To whom data/document is available
I will inform at the end of the study.
Under which criteria data/document could be used
I will inform at the end of the study.
From where data/document is obtainable
I will inform at the end of the study.
What processes are involved for a request to access data/document
I will inform at the end of the study.
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