Protocol summary
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Study aim
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Determine the supplementary effect of phytosomal 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.
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Design
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A randomized, controlled, double-blind, placebo-controlled clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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The intervention group (n=30) will receive one 250 mg phytosomal curcumin capsule daily for 12 weeks.
The control group (n=30) will receive one placebo (250 mg maltodextrin) daily for 12 weeks.
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Main outcome variables
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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
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Reason for update
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Using phytosomal curcumin instead of curcumin
Using a dose of 250 mg of phytosomal curcumin instead of 500 mg of curcumin.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N39
Registration date:
2019-11-26, 1398/09/05
Registration timing:
prospective
Last update:
2022-07-26, 1401/05/04
Update count:
1
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Registration date
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2019-11-26, 1398/09/05
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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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2020-04-20, 1399/02/01
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Expected recruitment end date
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2020-07-22, 1399/05/01
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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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Effect of phytosomal curcumin on lipid profile,fasting 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
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Public title
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The effect of phytosomal curcumin on fatty liver
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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, Diabetes, 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
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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 will be assigned to one of two phytosomal 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 phytosomal 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.
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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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2019-11-19, 1398/08/28
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Ethics committee reference number
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1398.461
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Degree of liver fibrosis
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Fibroscan device
2
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Description
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Degree of liver steatosis
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Fibroscan device
3
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Description
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Alkaline amino transferase
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Enzymatic photometric
4
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Description
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Aspartate amino transferase
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Enzymatic photometric
Secondary outcomes
1
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Description
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TG
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Enzymatic
2
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Description
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Tch
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Enzymatic
3
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Description
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HDL
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Enzymatic
4
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Description
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LDL
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Fried Wald Equation equation
5
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Description
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FBS
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Enzymatic
6
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Description
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Weight
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Digital scale
7
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Description
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Waist
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Meters irreversible
8
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Description
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BMI
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Timepoint
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Before intervention, end of intervention
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Method of measurement
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Body Mass Index Formula
Intervention groups
1
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Description
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Intervention group: phytosomal curcumin, 250 mg oral capsule, once daily 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: Placebo (maltodextrin) 250 mg orally, once daily 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
2
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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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The University of medical sciences Esfahan
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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 send as soon as possible, after receiving the request.
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Comments
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