The effect of citrulline supplementation on serum lipids, liver enzymes, inflammatory markers and hepatic steatosis in patient with nonalcoholic fatty liver disease
The main purpose: the effect of citrulline supplementation on serum lipids, liver enzymes, inflammatory markers and hepatic steatosis in patients with nonalcoholic fatty liver
randomized, double-blind, placebo-controlled
inclusion criteria: age 18 years and above;Concentrations of liver enzymes ALT and AST greater than 1.5 times normal;Evidence of nonalcoholic steatohepatitis in Fibroscan
Exclusion criteria:Not continue to cooperation;Those less than 10% supplemen at the end of the sixth and twelfth week consume.
Summary of the project:In this study, patients with non-alcoholic fatty liver if they wish to participate in the study consent form them to be taken.After 12 to 14 hours of fasting, 5 cc of blood is taken to measure their blood serum concentrations of lipids, inflammatory factors and other serum biochemical parameters and kept in the freezer.Participants randomly using the divided randomly classified into two groups:supplement and placebo group.Patients group supplement recived daily 2 grams of citrulline for three months and Patients in the control group recived placebo daily 2 grams. At the end of the third months, anthropometric, dietary recall and serum is taken and with fibroscan, changes in the degree of hepatic steatosis recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703194010N18
Registration date:2017-10-13, 1396/07/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-13, 1396/07/21
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
National Nutrition and Food Technology Research Institute Iran
Iran University of Medical Sciences of Colorectal Research Center
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of citrulline supplementation on serum lipids, liver enzymes, inflammatory markers and hepatic steatosis in patient with nonalcoholic fatty liver disease
Public title
investigate effect of citrulline in the treatment of non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for the study:
Age 18 and older;Concentrations of liver enzymes ALT and AST greater than 1.5 times normal;Evidence of nonalcoholic steatohepatitis in Fibroscan (Controlled Attenuation Parameter (CAP) score> 263);Have not a history of consumption alcohol more than 10 milligrams of per day for women and more than 20 mg per day for men;Not consume any dietary supplement in the past three months
not consume any hepatotoxic drugs such as phenytoin, lithium
Exclusion criteria:
Not continue to cooperation;Biliary diseases; autoimmune and cancer and inherited disorders affecting liver during the study;Those less than 10% supplemen at the end of the sixth and twelth week consume.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
Tehran
Postal code
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SBMU.nnftri.13950107
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
LDL-C
Timepoint
Being andend of intervention
Method of measurement
Enzymatic methods using kits
2
Description
HDL-C
Timepoint
Being andend of intervention
Method of measurement
Enzymatic methods using kits
3
Description
TG
Timepoint
Being andend of intervention
Method of measurement
Enzymatic methods using kits
4
Description
total Cholesterol
Timepoint
Being andend of intervention
Method of measurement
Enzymatic methods using kits
5
Description
FBS
Timepoint
Being andend of intervention
Method of measurement
Enzymatic methods using kits
6
Description
Fasting insulin
Timepoint
Being andend of intervention
Method of measurement
Radioimmunoassay µU/mL
7
Description
AST
Timepoint
Being andend of intervention
Method of measurement
Enzymatic methods using kits
8
Description
ALT
Timepoint
Being andend of intervention
Method of measurement
Enzymatic methods using kits µg/m
9
Description
HOMA
Timepoint
Being andend of intervention
Method of measurement
Calculation
10
Description
TNF-α
Timepoint
Being andend of intervention
Method of measurement
Elisa Pg/dl
11
Description
IL_6
Timepoint
Being andend of intervention
Method of measurement
Elisa Pg/dl
12
Description
steatosis
Timepoint
Being andend of intervention
Method of measurement
Ultrasonography Grade 0: absence of steatosis grade 1: mild steatosis grade 2: moderate steatosis grade 3: severe steatosis
Secondary outcomes
1
Description
Total energy intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire Kcal per day
2
Description
Carbohydrate intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire gram per day
3
Description
Protein intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire gram per day
4
Description
total fat intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire gram per day
5
Description
SAFA intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire gram per day
6
Description
PUFA intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire gram per day
7
Description
MUFA intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire gram per day
8
Description
total fiber intake
Timepoint
Beginning and end of intervention
Method of measurement
questionnaire gram per day
Intervention groups
1
Description
intervention group:2 gram citrulline per day for three months
Category
Treatment - Other
2
Description
placebo group:2 gram starche per day for three months
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Zahra Darabi
Street address
City
Tehran
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
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
tehran
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
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Colorectal Research Center,IRAN University of Medical Sciences
Full name of responsible person
shahram agah
Street address
nyayesh street.rasol akram,hospital
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Colorectal Research Center,IRAN University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Full name of responsible person
Azita Hekmatdoust
Position
Nutritionist
Other areas of specialty/work
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
Tehran
Postal code
Phone
+98 21 2235 7483
Fax
Email
a_HEKMAT2000@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sci
Full name of responsible person
Azita Hekmatdoust
Position
nutritionist
Other areas of specialty/work
Street address
West arghavan, Sanaat square, Farahzadi boulvard, Shahrake gharb
City
Tehran
Postal code
Phone
+98 21 2235 7483
Fax
Email
a_hekmat2000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zahra Darabi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 8888 8781
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)