The effect of hydro-alcoholic extract of Portulaca Oleracea L. (purslane) on Liver enzymes, Glycemic status, lipid pforile, Gluathione peroxidase activity, Adiponectin, NF-κB, and NF-κB gene expression in non-alcoholic fatty liver disease: a randomized, double-blind clinial trial.
The aim of the present study is to evaluate the effect of hydro-alcoholic extract of purslane in patients with non-alcoholic fatty liver disease (NAFLD). In a 12-week randomized, double-blind, clinical trial, 88 patients will be assigned to take either purslane extract capsule (containing 300 mg purslane extract) or placebo capsule. The study will be explained to each subject, who signs an informed consent. Steatosis grade will be determined by ultrasonography once at the beginning of the study and at the end of week 12. Three 24-hour recalls will be taken at the beginning and at the end of the study, including two working days and one weekend day. Diets will be analyzed for calorie and nutrient composition. Patient’s adherence to the study will be monitored every 15 days using telephone contact. Fasting blood samples will be obtained at baseline and at the end of study. Fasting blood sugar, insulin, total cholesterol, triglyceride, HDL-C, LDL-C, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, alkaline phosphatase, glutathione peroxidase, total bilirubin, adiponectine, NF-κB and NF-κB gene expression will be assessed by appropriate methods. The study protocol has been approved by ethics committee of Iran University of Medical Sciences.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701172709N44
Registration date:2017-04-10, 1396/01/21
Registration timing:prospective
Last update:
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, lipid pforile, Gluathione peroxidase activity, Adiponectin, NF-κB, and NF-κB gene expression in non-alcoholic fatty liver disease: a randomized, double-blind clinial 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 between 25 to 35 kg/m2
Exclusion criteria:
• Other acute or chronic hepatic disorders (hepatitis B or C)
• Biliary diseases
• Cancer
• Consumption of omega-3 and vitamin E supplement
• Alcohol use
• Pregnancy, lactation
• No use of hepatotoxic medications during last month
• Hypertension
• History of cardiovascullar disease
• Nephrolithiasis (oxalate stones) or history of nephrolithiasis
• Changing medication dosage during the study
• Compliacne less than 80%
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
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 (U/L)
2
Description
Aspartate aminotransferase (AST)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit (U/L)
Secondary outcomes
1
Description
Glutathione peroxidase (GPX)
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit (U/g Hb)
2
Description
NF-κB
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit (ELISA method)
3
Description
Adiponectin
Timepoint
At the begining and at the end of week 12
Method of measurement
Laboratory kit (ng/ml)
Intervention groups
1
Description
Intervention group: consumption of one capsule per day (containing 300 mg hydroethanolic extract of purslane) for 12 weeks
Category
Treatment - Other
2
Description
Control group: consumption of one placebo capsule for 12 weeks