Effect of curcumin on lipid profile, blood glucose, anthropometric indices, hepatic function and degree of steatosis, and liver fibrosis measured by fibroscan in non-alcoholic fatty liver patients: a double-blind clinical trial
Determine the supplementary effect of curcumin on lipid profile (Tch, TG, LDL, HDL), fasting blood glucose (FBS), anthropometric indices (weight, height, waist circumference, BMI), fibroscan findings, and liver function (ALT, AST) in non-alcoholic fatty liver disease.
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
Patients with fatty liver in Imam Musa Sadr Clinic will be included in the study if they meet all criteria and obtain written consent. The samples will be randomly divided into intervention and placebo groups and will be studied for 12 weeks. Before and after the intervention lipid profile, blood glucose, anthropometric indices, liver enzymes and degree of steatosis and liver fibrosis will be measured. To double-blind this study, all capsules were coded as A and B prior to study initiation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, age 18-65 years, non-alcoholic fatty liver
Exclusion criteria: Pregnancy and lactation, chronic disease, use of drugs affecting the liver, weight loss and bariatric surgery
Intervention groups
The intervention group (n=30) will receive one 500 mg curcumin capsule daily for 12 weeks.
The control group (n=30) will receive one placebo (500 mg lactose) daily for 12 weeks.
Main outcome variables
Primary outcome: Liver enzymes (ALT, AST), degree of fibrosis, and liver steatosis
Secondary outcome: HDL, LDL, Tch, TG, FBS, anthropometric indices (height, weight, waist circumference, BMI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N39
Registration date:2019-11-26, 1398/09/05
Registration timing:prospective
Last update:2019-11-26, 1398/09/05
Update count:1
Registration date
2019-11-26, 1398/09/05
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of curcumin on lipid profile, blood glucose, anthropometric indices, hepatic function and degree of steatosis, and liver fibrosis measured by fibroscan in non-alcoholic fatty liver patients: a double-blind clinical trial
Public title
The effect of curcumin on fatty liver
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
age 18-65 years
Non-alcoholic fatty liver (Grade 1-3) diagnosed by previous ultrasound
Exclusion criteria:
Pregnancy and lactation
Alcoholic fatty liver disease
Tobacco consumption
Heart, Lung and Kidney Diseases, Hepatitis, Cirrhosis, Biliary and Immune Disorders, Hypertension, Diabetes, Hypothyroidism, Cushing's Syndrome
Intake of lipid and glucose lowering drugs, Vitamin E and D, orthoedoxic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexate
Weight loss and bariatric surgery in the last year
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin and placebo groups.The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind clinical trial (participant, researcher). The curcumin supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences