Protocol summary
-
Study aim
-
Determination of the effect of curcumin-piperine supplementation on cardiometabolic factors, hepatic steatosis and fibrosis of fibroscan results and liver function in patients with non-alcoholic fatty liver disease
-
Design
-
This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. Sixty participants will randomly allocated to receive curcumin-piperine supplement per day (n = 30) or placebo (n = 30).
-
Settings and conduct
-
In this study, patients with NAFLD will recruited from Imam Musa Sadr Clinic , Isfahan, Iran. Subjects will stratified according to gender. Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist.The curcumin-piperine supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Tendency to participate in the study; People aged 18-65 years; Patients with Non-alcoholic fatty liver (grade 3-1) diagnosed by ultrasound
Exclusion criteria: Pregnancy and lactation; Patients with Alcoholic Fatty Liver; Smoking; People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, hypothyroidism and Cushing's syndrome; Consumption of lipid and glucose lowering medicine, Vitamin E, Vitamin D, Orsodeoxycholic acid, Phenytoin, Tamoxifen, Lithium, Corticosteroids and Methotrexate; Weight loss and bariatric surgery in the last year
-
Intervention groups
-
Individuals will randomly assigned to two groups to receive 500 mg/day curcumin-piperine supplement or placebo for 12 weeks.
-
Main outcome variables
-
TG; TC; HDL; LDL; Weight; BMI; Waist circumference; FBS; ALT; AST; Hepatic steatosis and fibrosis
General information
-
Reason for update
-
Given that underlying diseases such as metabolic syndrome and diabetes contribute to the development of non-alcoholic fatty liver disease by disrupting metabolic factors, a percentage of patients with non-alcoholic fatty liver disease have diabetes. As a result, based on the advice of the consulting physician, it was suggested that the presence of diabetes be excluded from the study exclusion criteria in order to make the design and its results closer to the community.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20121216011763N42
Registration date:
2020-01-10, 1398/10/20
Registration timing:
registered_while_recruiting
Last update:
2025-06-12, 1404/03/22
Update count:
1
-
Registration date
-
2020-01-10, 1398/10/20
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-12-21, 1398/09/30
-
Expected recruitment end date
-
2020-04-19, 1399/01/31
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of Curcumin-Piperine supplementation on cardiometabolic factors, hepatic steatosis and fibrosis of fibroscan results and liver function in patients with non-alcoholic fatty liver disease: a randomized double-blind clinical trial
-
Public title
-
Effect of Curcumin-Piperine in Fatty Liver
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Tendency to participate in the study
People aged 18-65 years
Patients with Non-alcoholic fatty liver (grade 3-1) diagnosed by ultrasound
Exclusion criteria:
Pregnancy and lactation
Patients with Alcoholic Fatty Liver
Smoking
People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, hypothyroidism and Cushing's syndrome
Consumption of lipid and glucose lowering medicine, Vitamin E, Vitamin D, Orsodeoxycholic 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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-11-05, 1398/08/14
-
Ethics committee reference number
-
IR.MUI.RESEARCH.REC.1398.462
Health conditions studied
1
-
Description of health condition studied
-
Nonalcoholic fatty liver
-
ICD-10 code
-
K76.0
-
ICD-10 code description
-
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
-
Description
-
TG
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
2
-
Description
-
TC
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
3
-
Description
-
HDL
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
4
-
Description
-
LDL
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Enzymatic method
5
-
Description
-
Weight
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Digital scale
6
-
Description
-
Waist circumference
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
non-stretching tape measure
7
-
Description
-
BMI
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Dividing the weight into kilograms by squared height by meter
8
-
Description
-
ALT
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Enzymatic photometric method
9
-
Description
-
AST
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Enzymatic photometric method
10
-
Description
-
Hepatic steatosis and fibrosis
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Fibroscan
Intervention groups
1
-
Description
-
Intervention group: A daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) will recive after meal for 12 weeks.
-
Category
-
Treatment - Other
2
-
Description
-
Control group: A daily placebo capsule(500 mg lactose) will recive after meal for 12 weeks.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Esfahan 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
The collected deidentified for the primary outcome measure only will be shared.
-
When the data will become available and for how long
-
12 months after publication
-
To whom data/document is available
-
Available for people working in academic institutions
-
Under which criteria data/document could be used
-
To conduct similar studies
-
From where data/document is obtainable
-
askari@mui.ac.ir
-
What processes are involved for a request to access data/document
-
The data will send as soon as possible, after receiving the request.
-
Comments
-