Protocol summary
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Study aim
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The effects of curcumin plus piperine supplementation on cardiometabolic risk factors and fibroscan findings in patients with moderate-to-high hepatic steatosis : a randomized double blind placebo-controlled trial
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Design
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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).
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Settings and conduct
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The present study is a double-blind, randomized, parallel clinical trial. The target population includes those with non-alcoholic fatty liver disease (NAFLD) with 2 and 3 grade referred to the Imam Musa Sadr Clinic who are diagnosed according to the sonography results by a Digestive and liver specialist. Split and study for12 weeks. Before and after the intervention, steatosis and fibrosis degree, serum HS-CRP level, liver enzyme, anthropocentric indices (body mass index and waist circumference), fasting blood sugar and blood pressure will be measured. To double-blind this study, all capsules were coded as A and B prior to study initiation
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Willingness to participation in the study, Age 18-65 years, Evidence of NAFLD with 2 and 3 grade by sonography which previously diagnosed
Exclusion criteria: Alcohol use, People with chronic diseases, liver diseases, biliary disorders, Use of the mentioned drugs within three months of study,weight loss.
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Intervention groups
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Intervention group a daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) and placebo group a daily corn starch capsule will receive after meal for 12 weeks.
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Main outcome variables
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TG; TC; HDL; LDL; Weight; BMI; Waist circumference; FBS; ALT; AST; Hepatic steatosis and fibrosis, Hs-CRP, BP
General information
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Reason for update
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Due to the prevalence of COVID-19 and the lack of patients with non-alcoholic steatohepatitis (NASH), the title of the project has changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N47
Registration date:
2020-05-14, 1399/02/25
Registration timing:
prospective
Last update:
2022-04-10, 1401/01/21
Update count:
1
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Registration date
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2020-05-14, 1399/02/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-09-22, 1399/07/01
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Expected recruitment end date
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2021-05-22, 1400/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of curcumin plus piperine supplementation on cardiometabolic risk factors and fibroscan findings in patients with moderate-to-high hepatic steatosis : a randomized double blind placebo-controlled trial
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Public title
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Effect of Curcumin-Piperine in moderate-to-high hepatic steatosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to participation in the study
Age 18-65 years
Evidence indicating non alcoholic fatty liver disease (NAFLD) white grade 2 and 3 diagnosed with sonography.
Exclusion criteria:
Alcohol use
People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, diabetes, hypothyroidism and Cushing's syndrome
Consumption of Metformin, Vitamin E, Orsodeoxycholic acid, Phenytoin, tamoxifen, Lithium, Corticosteroids and Methotrexate within three months of the study.
Weight loss or bariatric surgery in recent years
Pregnancy
Supplement intolerance and unexpected adverse effects
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and body mass index 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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is a double blind clinical trial (participant, researcher). The curcumin supplement and its placebo (identical from color, odor and shape) 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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-12-07, 1398/09/16
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Ethics committee reference number
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IR.NIMAD.REC.1398.306
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver disease (NAFLD)
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ICD-10 code
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R94.5
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ICD-10 code description
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Abnormal results of liver function studies
Primary outcomes
1
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Description
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Triglyceride (TG)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzymatic method
2
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Description
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Total Cholesterol (TC)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzymatic method
3
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Description
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Low density lipoprotein (LDL)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzymatic method
4
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Description
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High density lipoprotein (HDL)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzymatic method
5
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Description
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Weight
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Digital scale
6
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Description
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Waist Circumference (WC)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Non-stretching tape measure
7
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Description
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Body mass index (BMI)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Dividing the weight into kilograms by squared height by meter
8
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Description
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Aspartate aminotransferase (AST)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzymatic photometric method
9
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Description
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Alanine aminotransferase (ALT)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzymatic photometric method
10
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Description
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Hepatic steatosis and fibrosis
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Fibroscan
11
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Description
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Fasting blood sugar (FBS)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzymatic
12
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Description
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blood pressure
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Sphygmomonometer
13
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Description
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Serum levels of High sensitive C-reactive protein (Hs-CRP)
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Timepoint
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Before intervention and 12 weeks after intervention
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Method of measurement
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Enzyme-linked immunosorbent assay (ELISA) kits
Intervention groups
1
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Description
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Intervention group: A daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) will receive after meal for 12 weeks.
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Category
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Treatment - Other
2
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Description
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Control group: A daily placebo capsule(500 mg maltodextrin) will receive after meal for 12 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The collected deidentified for the primary outcome measure only will be shared
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When the data will become available and for how long
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12 months after publication
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To whom data/document is available
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Available for people working in academic institutions
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Under which criteria data/document could be used
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To conduct similar studies
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From where data/document is obtainable
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askari@mui.ac.ir
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What processes are involved for a request to access data/document
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The data will be sent to the person within two weeks after receiving the request and reviewing the request.
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Comments
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