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
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Protocol summary
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, diabetes, 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
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
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, diabetes, 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
شرایط ورود: تمایل به شرکت در مطالعه، سن 18 تا 65 سال، بیماران مبتلا به کبد چرب غیرالکلی (گرید3-1) تشخیص داده شده توسط سونوگرافی
شرایط عدم ورود: بارداری و شیردهی، افراد مبتلا به کبد چرب الکلی، مصرف دخانیات، افراد مبتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، دیابت، هیپوتیروئیدیسم و سندرم کوشینگ، مصرف داروهای کاهنده چربی و قند خون، ویتامین E، ویتامین D، اورسودئوکسی کولیک اسید، فنی توئین، تاموکسیفن، لیتیوم، کورتیکواستروئیدها و متوتروکسات، کاهش وزن و جراحی باریاتریک در یک سال اخیر
شرایط ورود: تمایل به شرکت در مطالعه، سن 18 تا 65 سال، بیماران مبتلا به کبد چرب غیرالکلی (گرید3-1) تشخیص داده شده توسط سونوگرافی
شرایط عدم ورود: بارداری و شیردهی، افراد مبتلا به کبد چرب الکلی، مصرف دخانیات، افراد مبتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، هیپوتیروئیدیسم و سندرم کوشینگ، مصرف داروهای کاهنده چربی و قند خون، ویتامین E، ویتامین D، اورسودئوکسی کولیک اسید، فنی توئین، تاموکسیفن، لیتیوم، کورتیکواستروئیدها و متوتروکسات، کاهش وزن و جراحی باریاتریک در یک سال اخیر
شرایط ورود: تمایل به شرکت در مطالعه، سن 18 تا 65 سال، بیماران مبتلا به کبد چرب غیرالکلی (گرید3-1) تشخیص داده شده توسط سونوگرافی شرایط عدم ورود: بارداری و شیردهی، افراد مبتلا به کبد چرب الکلی، مصرف دخانیات، افراد مبتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، دیابت، هیپوتیروئیدیسم و سندرم کوشینگ، مصرف داروهای کاهنده چربی و قند خون، ویتامین E، ویتامین D، اورسودئوکسی کولیک اسید، فنی توئین، تاموکسیفن، لیتیوم، کورتیکواستروئیدها و متوتروکسات، کاهش وزن و جراحی باریاتریک در یک سال اخیر
General information
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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.
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.
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با توجه به اینکه بیماری های زمینه ای مانند سندروم متابولیک و دیابت از طریق مختل کردن فاکتورهای متابولیک، زمینه ساز ایجاد بیماری کبد چرب غیر الکلی هستند، لذا درصدی از بیماران مبتلا به کبد چرب غیر الکلی مبتلا به دیابت می باشند، در نتیجه با توجه به توصیه پزشک مشاور،پیشنهاد گردید برای نزدیک تر بودن طرح و نتایج آن به جامعه، وجود بیماری دیابت از معیار های عدم ورود مطالعه حذف گردد.
با توجه به اینکه بیماری های زمینه ای مانند سندروم متابولیک و دیابت از طریق مختل کردن فاکتورهای متابولیک، زمینه ساز ایجاد بیماری کبد چرب غیر الکلی هستند، لذا درصدی از بیماران مبتلا به کبد چرب غیر الکلی مبتلا به دیابت می باشند، در نتیجه با توجه به توصیه پزشک مشاور،پیشنهاد گردید برای نزدیک تر بودن طرح و نتایج آن به جامعه، وجود بیماری دیابت از معیار های عدم ورود مطالعه حذف گردد.
Pregnancy and lactation
Patients with Alcoholic Fatty Liver
Smoking
People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, diabetes, 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
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
Pregnancy and lactation Patients with Alcoholic Fatty Liver Smoking People with heart , pulmonary and kidney diseases, hepatitis, cirrhosis, biliary and immune disorders, hypertension, diabetes, 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
بارداری و شیردهی
افراد مبتلا به کبد چرب الکلی
مصرف دخانیات
افراد مبتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، دیابت، هیپوتیروئیدیسم و سندرم کوشینگ
مصرف داروهای کاهنده چربی و قند خون، ویتامین E، ویتامین D، اورسودئوکسی کولیک اسید، فنی توئین، تاموکسیفن، لیتیوم، کورتیکواستروئیدها و متوتروکسات
کاهش وزن و جراحی باریاتریک در یک سال اخیر
بارداری و شیردهی
افراد مبتلا به کبد چرب الکلی
مصرف دخانیات
افراد مبتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، هیپوتیروئیدیسم و سندرم کوشینگ
مصرف داروهای کاهنده چربی و قند خون، ویتامین E، ویتامین D، اورسودئوکسی کولیک اسید، فنی توئین، تاموکسیفن، لیتیوم، کورتیکواستروئیدها و متوتروکسات
کاهش وزن و جراحی باریاتریک در یک سال اخیر
بارداری و شیردهی افراد مبتلا به کبد چرب الکلی مصرف دخانیات افراد مبتلا به بیماری های قلبی، ریوی، کلیوی، هپاتیت، سیروز، اختلالات صفراوی و سیستم ایمنی، فشار خون بالا، دیابت، هیپوتیروئیدیسم و سندرم کوشینگ مصرف داروهای کاهنده چربی و قند خون، ویتامین E، ویتامین D، اورسودئوکسی کولیک اسید، فنی توئین، تاموکسیفن، لیتیوم، کورتیکواستروئیدها و متوتروکسات کاهش وزن و جراحی باریاتریک در یک سال اخیر
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.
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
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
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
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
Street address
Hezarjarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
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
Secondary outcomes
empty
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Musa Sadr Clinic
Full name of responsible person
Gholamreza Askari
Street address
Foroughi Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezar Jarib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
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
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1792 2110
Fax
+98 31 1792 2199
Email
askari@mui.ac.ir
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.