The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status and lipid profile in non-alcoholic fatty liver disease: a randomized, double-blind clinical trial.
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General information
Being volunteer or Wishing to attend
Age 18 years or older
Alanine aminotransferase (ALT) greater than 19 IU/L for women and greater than 30 IU/L for men
Evidence of fatty liver in ultrasonography with a score of 1 or more
BMI ≥ 25 kg/m2
Being volunteer or Wishing to attend
Age 18 years or older
Alanine aminotransferase (ALT) greater than 19 IU/L for women and greater than 30 IU/L for men
Evidence of fatty liver in ultrasonography with a score of 1 or more
BMI: 20-40 kg/m2
Being volunteer or Wishing to attend Age 18 years or older Alanine aminotransferase (ALT) greater than 19 IU/L for women and greater than 30 IU/L for men Evidence of fatty liver in ultrasonography with a score of 1 or more BMI ≥ 25: 20-40 kg/m2
تمایل به شرکت در مطالعه
سن 18 سال به بالا
سطوح سرمي آنزيم کبدي (ALT بيشتر از 19 U/l براي زنان و بيشتر از U/L 30 براي مردان)
درجه استئاتوز کبدي يک و بالاتر در اولتراسونوگرافي بيماران
BMI ≥ از 25 kg/m2
تمایل به شرکت در مطالعه
سن 18 سال به بالا
سطوح سرمي آنزيم کبدي (ALT بيشتر از 19 U/l براي زنان و بيشتر از U/L 30 براي مردان)
درجه استئاتوز کبدي يک و بالاتر در اولتراسونوگرافي بيماران
BMI: 20-40 kg/m2
تمایل به شرکت در مطالعه سن 18 سال به بالا سطوح سرمي آنزيم کبدي (ALT بيشتر از 19 U/l براي زنان و بيشتر از U/L 30 براي مردان) درجه استئاتوز کبدي يک و بالاتر در اولتراسونوگرافي بيماران BMI ≥ از 25: 20-40 kg/m2
Protocol summary
Study aim
The aim of this study was to evaluate the effect of portulaca oleracea (purslane) hydroalcoholic extract in patients with non-alcoholic fatty liver disease (NAFLD).
Design
A 12-week randomized, double-blinded, parallel clinical trial on 74 patients with NAFLD.
Settings and conduct
Patients are randomly divided into intervention and placebo groups (37 patients in each group). The study process is described for each patient and a written consent form is obtained from the patients. The degree of hepatic steatosis is determined using ultrasound once at the beginning and again at week 12 of the study. The 3-day of 24-hour dietary recall is taken at the beginning and end of the study. A diet for 10% weight loss will be provided to each patients individually by a nutritionist. Patients' compliance is monitored by telephone every 15 days. Fasting blood samples are taken from patients at the beginning and at end of the study. The study protocol has been approved by the ethics committee of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Men and women with non-alcoholic fatty liver disease whose ALT is greater than 30 U / l and more than 19 U / L, respectively, and who do not have chronic liver disease, cardiovascular disease, hypertension, or kidney stones are eligible to participate in the study.
Intervention groups
Intervention group: one capsule containing 300 mg of purslane hydroalcoholic extract daily.
Placebo Group: A capsule daily similar in appearance to drug capsules, filled with toasted powder.
Main outcome variables
Serum levels of ALT and AST are the main outcomes of the study. Other variables include fasting blood glucose, insulin, total cholesterol, triglycerides, HDL-C, LDL-C, gamma glutamyl transferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectin, NF-kB and expression of the NF-κB gene.
General information
Reason for update
1. Submission of information in the old version of IRCT
2. Creating some changes in the sample size after the approval of the Vice Chancellor for Research of Iran University of Medical Sciences
3. Correcting the secondary outcome variables
Acronym
IRCT registration information
IRCT registration number:IRCT201701172709N44
Registration date:2017-04-10, 1396/01/21
Registration timing:prospective
Last update:2020-06-21, 1399/04/01
Update count:2
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Iran university of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status and lipid profile in non-alcoholic fatty liver disease: a randomized, double-blind clinical trial.
Public title
Effect of purslane extract on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being volunteer or Wishing to attend
Age 18 years or older
Alanine aminotransferase (ALT) greater than 19 IU/L for women and greater than 30 IU/L for men
Evidence of fatty liver in ultrasonography with a score of 1 or more
BMI: 20-40 kg/m2
Exclusion criteria:
Other acute or chronic hepatic disorders (hepatitis B or C)
Biliary diseases
Cancer
Hypertension
History of cardiovascular disease
Nephrolithiasis (oxalate stones) or history of oxalate stones
Consumption of omega-3 and vitamin E supplement
Alcohol use
Use of hepatotoxic medications during last month
Changing medication dosage during the study
Pregnancy
Lactation
Compliacne less than 80%
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method has been used for randomization. Blocks of size 4 are generated using www.sealedenvelope.com. In order to conceal in the randomization process, unique codes have been used on the medicine boxes, which are produced by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to apply concealment in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be produced by the software.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IR.IUMS.REC 1395.95-04-27-9221324202
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Alanine aminotransferase (ALT)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit
2
Description
Aspartate aminotransferase (AST)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit
Secondary outcomes
1
Description
Weight
Timepoint
At the begining and at the end of week 12
Method of measurement
Seca scale
2
Description
Body mass index (BMI)
Timepoint
At the begining and at the end of week 12
Method of measurement
Calculation: weight (in kilograms) divided by the square of height (in meters)
3
Description
Waist circumference
Timepoint
At the beginning and at the end of week 12
Method of measurement
Non-stretchable measuring tape
4
Description
Liver steatosis
Timepoint
At the beginning and at the end of week 12
Method of measurement
Sonography
5
Description
Systolic blood pressure (SBP)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Sphygmomanometer
6
Description
Diastolic blood pressure (DBP)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Sphygmomanometer
7
Description
Total cholesterol
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
8
Description
Triglyceride (TG)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
9
Description
High density lipoprotein (HDL)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
10
Description
Low density lipoprotein (LDL)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
11
Description
Albumin (ALB)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
12
Description
Alkaline phosphatase (ALP)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
13
Description
Gamma glutamyl transferase (GGT)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit
14
Description
Total bilirubin
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
15
Description
Fasting blood sugar (FBS)
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit
16
Description
Insulin
Timepoint
At the beginning and at the end of week 12
Method of measurement
Laboratory kit (ELISA)
17
Description
Homeostatic model assessment of insulin resistance (HOMA-IR)
Dr. Seyyed Abbas Motevallian, deputy head of Research and Technology, Iran University of Medical Sci
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Fax
Email
research-m@iums.ac.ir
Web page address
https://vcr.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
00982188607941- 00982188607945
Fax
+98 21 8862 2707
Email
Shidfar.f@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Fax
+98 21 8862 2707
Email
Farzadshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Position
PhD of Nutrition, Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Health, Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 7945
Fax
+98 21 8862 2707
Email
Farzadshidfar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Information on the main outcomes at the end of the study can be shared.
When the data will become available and for how long
The access period will be 6 months after the publication of the results.
To whom data/document is available
The data from this study will only be available to researchers working at academic and scientific institutions.
Under which criteria data/document could be used
Six months after the publication of the articles of this project, upon request from the corresponding author and his agreement, the study data can be made available to researchers.
From where data/document is obtainable
Applicants can contact the corresponding author via email or the following postal address to receive the required data. Nutrition department, School of health, Iran University of Medical Sciences, Hemmat highsway, Tehran Phon number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com
What processes are involved for a request to access data/document
Applicants will be able to access the data from the present study no later than one week by sending an email to the corresponding author.