Protocol summary
-
Study aim
-
Effects of naringenin supplement on Aminoteransferas levels, insulin resistance, cardiovascular risk factors, and serum levels of adiponectin and neuregulin-4 in obese or overweight Non-alcoholic fatty liver disease patients
-
Design
-
Randomized, double-blind, placebo-controlled, parallel trial with 2 arms (each arm includes 22 patients) and stratified permuted block randomization is used
-
Settings and conduct
-
Patients selection from Naft hospital, Tehran
Taking 2 capsules per day for 4 weeks
Blood sample collection,anthropometric analysis, sonography and filling out questionnaires before and after the intervention
Blinding patients and investigators
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: 20-65 years old, BMI range between 25-35, diagnosis of Non-alcoholic fatty liver disease based on sonography, informed consent for participating in the study;
exclusion criteria: regular consumption of NSAIDs, antibiotics, corticosteroids, anti-hypertensive, lipid-lowering and weight-lowering agents, regular consumption of multivitamin-mineral, antioxidants, omega-3 and probiotic and also the consumption of herbal drinks such as silymarin, a pathological diagnosed condition affecting the liver such as viral hepatitis and liver transplantation, past medical history of diabetes, organs failure, gastrointestinal tract, thyroid and auto-immune disorders, kidney and severe mental diseases, cardiovascular accidents, pregnancy, intention to be pregnant, breastfeeding and menopause status, addiction and consumption of alcoholic drinks, professional exercise
-
Intervention groups
-
The intervention group should consume two capsules that each containing 100 mg naringenin, and the control group should consume two placebo capsules
-
Main outcome variables
-
Aminoteransferase levels, insulin resistance, cardiovascular risk factors, and serum levels of adiponectin and neuregulin-4
General information
-
Reason for update
-
Dosage and duration of naringenin supplementation were respectively changed from 400 mg/day and 8 weeks to 200 mg/day and 4 weeks based on the study pharmacist proposal.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20131125015536N12
Registration date:
2020-08-06, 1399/05/16
Registration timing:
prospective
Last update:
2021-01-16, 1399/10/27
Update count:
1
-
Registration date
-
2020-08-06, 1399/05/16
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-10-10, 1399/07/19
-
Expected recruitment end date
-
2021-06-09, 1400/03/19
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effects of Naringenin on Aminotransferase Level, Insulin Resistance, Cardiovascular Risk Factors, and Adiponectin and Neuregulin-4 levels in Overweight or Obese Patients with Non-alcoholic Fatty Liver Disease: A Randomized Controlled trial
-
Public title
-
Effects of Naringenin Supplement on Non-alcoholic Fatty Liver Disease
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
20 to 65 years old men and women
Range of body mass index (BMI) should be between 25 to 35 Kg/m2
Diagnosis of Non-alcoholic fatty liver disease based on sonography by specialist
Informed consent for participating in the study
Exclusion criteria:
Regular consumption of Non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, corticosteroids, anti-hypertensive agents, lipid-lowering agents and weight-lowering agents in the period of last 3 months
Regular consumption of multivitamin-minerals, antioxidants, omega3 supplement at the dosages of more than daily needs and also consumption of probiotic supplements and herbal drinks such as silymarine in the priod of last 3 months
Diagnosis of pathological conditions affecting the liver such as viral hepatitis and liver transplantation
Past medical history of diabetes, gastrointestinal tract disorders, organs failure, thyroid disorders, kidney diseases, autoimmune diseases, severe mental diseases and several types of malignancies
Past medical history of cardiovascular accidents in the period of last 3 months
Pregnancy, intention to be pregnant in the next 3 months, breastfeeding and menopause status
Being addict, consumption of alcoholic drinks
Professional exercise
-
Age
-
From 20 years old to 65 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
44
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
In order to randomize the study groups, we will use the Stratified Permuted Block Randomization method. First, patients are stratified in terms of gender randomization, and since there will be different confounding factors in this study, a score for each individual in terms of disease risk is determined based on these confounding factors (BMI in the range of 29.9-25 = 0 and BMI in the range of ٔ30-35=1, age in the range of 20-43 years = 0 and age in the range of 43-65 years = 1, degree of mild fatty liver disease = 0 and degree of moderate and severe fatty liver disease = 1). The sum of these scores will be at least 0 and at most 3. According to these, people who get a score of zero and one are considered as low risk and the people who get a score of two and three are considered as high risk. After that, they will be randomized separately.
Block sizes: 4 4 2 6 2
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Double-blind study (participants and researcher blinding) through naringenin and placebo supplement packaging in one shape and naming with A and B letters. The mentioned process has done by a third person, so that the researcher and the patients are not aware of the type of intervention.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-05-06, 1399/02/17
-
Ethics committee reference number
-
IR.TUMS.VCR.REC.1399.347
Health conditions studied
1
-
Description of health condition studied
-
Non-alcoholic fatty liver disease
-
ICD-10 code
-
K76.0
-
ICD-10 code description
-
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
-
Description
-
Serum aminoteransferase levels
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Blood levels through special kit
2
-
Description
-
Insulin resistance index
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Formula
3
-
Description
-
hs-CRP
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Blood levels through special kit
4
-
Description
-
Adiponectin
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Blood levels through special kit
5
-
Description
-
Neuregulin-4
-
Timepoint
-
Before and after intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Blood levels through special kit
Secondary outcomes
1
-
Description
-
Blood pressure
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
pressure indicator
2
-
Description
-
Body mass index
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
calculating according to related formula
3
-
Description
-
weight
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Digital scale
4
-
Description
-
Height
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Standard tape meter
5
-
Description
-
physical activity score
-
Timepoint
-
every two weeks ( on the day 0, 14, 28)
-
Method of measurement
-
international physical activity questionnaire: short
6
-
Description
-
Lipid profile
-
Timepoint
-
Before and after the intervention (on the day of 0 and at the end of the next 4 weeks)
-
Method of measurement
-
Blood levels through special kit
Intervention groups
1
-
Description
-
Intervention group: Naringenin supplement (provided by Exir Nano Sina Co.) should consume before dinner and lunch at the dosages of 200 mg/day that divided into two 100 mg capsule per day for 4 weeks (method of naringenin extraction is alcoholic)
-
Category
-
Treatment - Other
2
-
Description
-
Control group: placebo (cellulose) should consume before dinner and lunch at the dosages of 200 mg/day that divided into two 100 mg capsule (provided by Exir Nano Sina Co.) per day for 4 weeks
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tehran 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
There is no further information
-
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