The effect of Nigella sativa consumption on lipid profile, liver enzymes, inflammatory factors and hepatic steatosis in patients with Non-Alcoholic Fatty Liver Disease(NAFLD)
The effect of curcumin supplementation on serum lipids, liver enzymes, inflammatory markers and hepatic steatosis in patients with nonalcoholic fatty liver.
Design
Randomized, double-blind, placebo-controlled
Settings and conduct
In this study, patients with non-alcoholic fatty liver reffering to Baqiatalah Hospital, with tendency to participate in the study with informed consent are recruited. After 12 to 14 hours of fasting, 5 cc of blood is taken to measure lipids profile, inflammatory factors and other serum biochemical parameters and kept in the freezer. Participants are randomly divided and classified into two groups: supplement and placebo group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 years and above; level of liver enzymes (ALT and AST) 1.5 times greater than normal; Evidence of nonalcoholic steatohepatitis in Fibroscan. Exclusion criteria: Not continue to cooperate; consumed less than 90% of supplements at the end of the sixth and twelfth week of study.
Intervention groups
Patients group supplement will be recived daily 2 grams of Nigella sativa for three months and Patients in the control group will be recived placebo daily2 grams.
Main outcome variables
Low Density Lipoprotein Cholestrol (LDL-C), High Density Lipoprotein Cholestrol (HDL-C), Triglyceride(TG), Total Cholestrol, Fasting Blood Sugar(FBS), Insulin,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100524004010N25
Registration date:2018-07-24, 1397/05/02
Registration timing:registered_while_recruiting
Last update:2018-07-24, 1397/05/02
Update count:1
Registration date
2018-07-24, 1397/05/02
Registrant information
Name
Azita Hekmatdoost
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Institute of Nutrition Research
Country
Iran (Islamic Republic of)
Phone
+98 21 2293 0824
Email address
hekmat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nigella sativa consumption on lipid profile, liver enzymes, inflammatory factors and hepatic steatosis in patients with Non-Alcoholic Fatty Liver Disease(NAFLD)
Public title
The effect of Nigella sativa on Non-Alcoholic Fatty Liver Disease(NAFLD)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 years old and older
Evidence of nonalcoholic steatohepatitis in Fibroscan (Controlled Attenuation Parameter (CAP) score> 263)
absence of pregnancy and lactation
Exclusion criteria:
Unwillingness to continue study for any reason.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to receive curcumin or placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
For randomization process, simple randomization method is used by random number table. At the beginning of the study, in order to blind the researchers to group assignment, the cans containing the capsules are coded by another person instead of the researcher to A and B as intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Natio nal Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sc
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
Tehran
Province
Tehran
Postal code
123456
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.SBMU.nnftri.Rec.1395.121
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
(K75.8)
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
HOMA
Timepoint
Begining and end of the study
Method of measurement
Calculation
2
Description
TNF-α
Timepoint
Begining and end of the study
Method of measurement
Elisa
3
Description
IL-6
Timepoint
Begining and end of the study
Method of measurement
Elisa
4
Description
Hepatic Steatosis
Timepoint
Begining and end of the study
Method of measurement
Ultrasound
5
Description
LDL-C
Timepoint
Begining and end of the study
Method of measurement
Enzymatic methods using a kit
6
Description
HDL-C
Timepoint
Begining and end of the study
Method of measurement
Enzymatic methods using a kit
7
Description
TG
Timepoint
Begining and end of the study
Method of measurement
Enzymatic methods using a kit
8
Description
total Cholesterol
Timepoint
Begining and end of the study
Method of measurement
Enzymatic methods using a kit
9
Description
Serum Insulin
Timepoint
Begining and end of the study
Method of measurement
Radioimmunoassay
10
Description
FBS
Timepoint
Begining and end of the study
Method of measurement
Enzymatic methods using a kits
11
Description
AST
Timepoint
Begining and end of the study
Method of measurement
Enzymatic methods using a kits
12
Description
ALT
Timepoint
Begining and end of the study
Method of measurement
Enzymatic methods using a kit
13
Description
Total energy intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
14
Description
Carbohydrate intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
15
Description
Protein intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
16
Description
total fat intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
17
Description
SFA intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
18
Description
PUFA intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
19
Description
MUFA intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
20
Description
fiber intake
Timepoint
Begining and end of the study
Method of measurement
Recall Questionare
Secondary outcomes
1
Description
Total energy intake
Timepoint
Begining and end of the study
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: 2 gr per day nigella sativa daily for 3 months
Category
Treatment - Other
2
Description
Placebo group: 2 gr per day starch daily for 3 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The liver and gastroenterology clinic Baqiyat Allah Hospital
Full name of responsible person
Mina Darand
Street address
Mollasadra Ave.
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۷۱
Phone
+98 21 8805 0435
Email
mdarand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research
Full name of responsible person
Azita Hekmatdoost
Street address
Derakhti Ave.
City
Tehran
Province
Tehran
Postal code
1234567
Email
info@nnftri.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research
Full name of responsible person
Azita Hekmatdoost
Position
Nutritionist
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Hafezi Ave
City
Tehran
Province
Tehran
Postal code
123456
Phone
+98 21 2235 7483
Fax
Email
a_HEKMAT2000@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research
Full name of responsible person
Azita Hekmatdoost
Position
Nutritionist
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
Tehran
Province
Tehran
Postal code
123456
Phone
+98 21 2235 7483
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mina Darand
Position
Nutritionist
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
123456
Phone
+98 83 4523 8410
Email
mdarand@gmail.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
No - There is not 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