Evaluating the effect of Resveratrol supplement on lipid profile, hepatic enzymes, inflammatory factors, and hepatic fibrosis in patients with Nonalcoholic Fatty Liver Disease (NAFLD)
In this study, 50 patients with nonalcoholic steatohepatitis grade one or more will be randomly assigned to two groups receiving either resveratrol supplements or placebo for 12 weeks. Serum markers including blood lipids, liver enzymes, inflammatory markers and liver view in fibroscan and sonography will be measured before and after treatment and effects of resveratrol supplementation will be compared with placebo to determine the effects of resveratrol supplementation in the treatment of non-alcoholic fatty liver disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202014010N7
Registration date:2013-01-11, 1391/10/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-11, 1391/10/22
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute (NNFTRI)
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Resveratrol supplement on lipid profile, hepatic enzymes, inflammatory factors, and hepatic fibrosis in patients with Nonalcoholic Fatty Liver Disease (NAFLD)
Public title
Evaluation of the effects of Resveratrol Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid profile, blood glucose, Insulin Sensitivity, and Hepatic fibrosis in patients with Nonalcoholic Fatty Liver Disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 and older; Evidence of nonalcoholic steatohepatitis with steatosis grade higher or equal to 1 in ultrasonography; No history of Alcohol consumption or consuming less than 10 grams alcohol per day in women and less than 20 grams per day in men; Absence of other liver disorders, malignancies, cardiovascular, respiratory, and kidney disorders; Absence of pregnancy or lactation; Absence of taking any medications in the past three months; Absence of weight loss in the recent three months; Absence of endocrine and metabolism disorders. Exclusion criteria: Weight loss more than 10% of baseline body weight during the intervention period. Pregnancy; Disliking to continue the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
National Nutrition and Food Technology Research Institute
Street address
West Arghavan, Farahzadi Blv, Shahrak Gharb
City
Tehran
Postal code
Approval date
2012-08-20, 1391/05/30
Ethics committee reference number
046468
Health conditions studied
1
Description of health condition studied
Non Alcoholic Fatty Liver
ICD-10 code
K75.9
ICD-10 code description
Inflammatory liver disease, unspecified
Primary outcomes
1
Description
Liver Enzymes
Timepoint
at the first and at the 12th week of the study
Method of measurement
Biochemical analysis
Secondary outcomes
1
Description
Liver fibrosis
Timepoint
at the first and the end of the study
Method of measurement
Fibroscan
Intervention groups
1
Description
Intervention: Soft gel Resveratrol 500 mg once a day /12 weeks
Category
Treatment - Drugs
2
Description
Placebo: Edible paraffin soft gelonce a day/ 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
NAFLD Clinic
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Majid Hajifaraji
Street address
West Arghavan, Farahzadi Blv, Shahrak Gharb
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Azita Hekmatdoost
Position
PHD/ Assistant Proffessor
Other areas of specialty/work
Street address
West Arghavan, Farahzadi Blv, Shahrak Gharb
City
Tehran
Postal code
Phone
+98 21 2236 0656
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr Azita Hekmatdoost
Position
PHD/ Assistant Proffessor
Other areas of specialty/work
Street address
West Arghavan, Farahzadi Blv, Shahrak Gharb
City
Tehran
Postal code
Phone
+98 21 2235 7484
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)