The effect of curcumin-piperine supplementation on glycemic indices, lipid profiles, anthropometric indices and liver function in children with none- alcoholic fatty liver disease
determination of the effect of curcumin-piperine supplementation on glycemic indices, lipid profiles, anthropometric indices and liver function in children with none- alcoholic fatty liver disease
Design
Randomized clinical trial, double-blind, randomized control group of 60 patients. Randomization is done using a valid website and 4-block method.
Settings and conduct
This study will be performed in imam hossein children's Hospital, Isfahan. The researchers, participants will be unaware of assigned treatments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of NAFLD (grades 1–3) according to liver ultrasonography
children with BMI percentile>=85 for age
age 10-18 years old
Exclusion criteria: presence of hepatitis, Chronic liver disease , Cardiovascular, renal, Pulmonary, Hypothyroidism diseases and cancer
not consuming drugs that could affect on ALT level including HMG-COA reductase inhibitors, metformin
Intervention groups
intervention group: capsules containing curcumin- piperine each containing 500 mg of curcumin and 5 mg of piperine once a day. control group one capsule each containing 500 mg of maltodextrin
Main outcome variables
glycemic indices, lipid profiles, anthropometric indices, Liver function
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20171107037302N2
Registration date:2021-11-14, 1400/08/23
Registration timing:prospective
Last update:2021-11-14, 1400/08/23
Update count:0
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3434 3834
Email address
s.sarafbank@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin-piperine supplementation on glycemic indices, lipid profiles, anthropometric indices and liver function in children with none- alcoholic fatty liver disease
Public title
curcumin-piperine supplementation in children with none- alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of NAFLD (grades 1–3) according to liver ultrasonography
children with BMI percentile>=85 for age
age 10-18 years old
Exclusion criteria:
presence of hepatitis, Chronic liver disease , Cardiovascular, renal, Pulmonary, Hypothyroidism diseases and cancer
not consuming drugs that could affect on ALT level including HMG-COA reductase inhibitors, metformin
Age
From 10 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a reputable random number generation website. (Random number generation website: https://www.sealedenvelope.com/simple-randomiser/v1/lists)
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, children will not be aware of received intervention. furthermore, before the beginng of intervention, curcumin supplements and their placebo which are completely similar to each other, will be coded to A and B by a third person rather than main researcher to keep blindness of study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-20, 1400/07/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.303
Health conditions studied
1
Description of health condition studied
none- alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
weight
Timepoint
At the beginning of study - week 10
Method of measurement
Seca scale
2
Description
height
Timepoint
At the beginning of study - week 10
Method of measurement
Strip meter
3
Description
waist circumference
Timepoint
At the beginning of study - week 10
Method of measurement
strip meter
4
Description
hip circumference
Timepoint
At the beginning of study - week 10
Method of measurement
strip meter
5
Description
Body mass index
Timepoint
At the beginning of study - week 10
Method of measurement
formula
6
Description
Fasting blood sugar
Timepoint
At the beginning of study - week 10
Method of measurement
biochemical assessment
7
Description
triglycerides
Timepoint
At the beginning of study - week 10
Method of measurement
biochemical assessment
8
Description
low-density lipoprotein
Timepoint
At the beginning of study - week 10
Method of measurement
biochemical assessment
9
Description
high-density lipoprotein
Timepoint
At the beginning of study - week 10
Method of measurement
biochemical assessment
10
Description
Total cholesterol
Timepoint
At the beginning of study - week 10
Method of measurement
biochemical assessment
11
Description
Alanine aminotransferase
Timepoint
At the beginning of study - week 10
Method of measurement
biochemical assessment
12
Description
Aspartate aminotransferase
Timepoint
At the beginning of study - week 10
Method of measurement
biochemical assessment
Secondary outcomes
1
Description
Fasting insulin
Timepoint
At the begining of study - week 10
Method of measurement
biochemical assessment
Intervention groups
1
Description
Intervention group: Intervention group will receive a capsule containing curcumin-piperine in the amount of 500 mg of curcumin and 5 mg of piperine once a day for 10 weeks.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive capsules containing placebo. Each capsule contains 500 mg of maltodextrin for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
imam Hossein children's Hospital
Full name of responsible person
Mohaddese Abdi
Street address
Imam Khomeini Street - before Esteghlal Square
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
m.abdi4015@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behruz Ataei
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.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
Sahar Saraf-Bank
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences School
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
saraf2shr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar Saraf-Bank
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
nutrition
Street address
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences School
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
saraf2shr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar Saraf-Bank
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar jarib street, Isfahan University of Medical Sciences, Nutrition and Food Sciences school
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3172
Email
saraf2shr@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available