Protocol summary

Study aim
The goal of this study was to assess effect of licorice root supplementation on lipid profile, glycemia profile, hepatic enzymes, hepatic steatosis, and oxidative stress of nonalcoholic fatty liver disease.
Design
A randomized, placebo-controlled, double-blind clinical trial
Settings and conduct
In this study 60 women with NAFLD, aged 18 _ 65, and body mass index > 25, were recruited from Shahid motahari clinic in Shiraz, Iran. Patients were randomly allocated in ti licorice and control groups by randomization. Both the researchers and participants were blinded throughout the study until the end of statistical analysis. All data of anthropometric measurements, and laboratory tests were collected at baseline and after intervention. All patients were advised to perform physical activity and weight loss diet.
Participants/Inclusion and exclusion criteria
Women with NAFLD, aged 18 to 65 years, BMI > 25 and fatty liver in sonography
Intervention groups
Licorice group and control group Intake of 1000 mg licorice root extract powder in licorice group Intake of 1000 mg maltidextrin in control group
Main outcome variables
ALT, AST, GGT, FBS, insulin resistance, serum insulin, LDL, HDL, Ttal cholesterol, Triglycerid, Liver steatosis, Wheight and BMI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200903048603N1
Registration date: 2020-10-04, 1399/07/13
Registration timing: retrospective

Last update: 2020-10-04, 1399/07/13
Update count: 0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
Pouya Rostamizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 0111
Email address
pouyarostamizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2020-01-30, 1398/11/10
Scientific title
Effects of licorice root on metabolic factors, hepatic enzymes, hepatic steatosis, and oxidative stress in obese women with nonalcoholic fatty liver disease
Public title
"Effect of Licorice in treatment of Nonalcoholic Fatty Liver Disease"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of acute or chronic Liver disease Lack of using of Tabacco or alcohol Lack of cardiovascular diseases, and Hypertension Lack of Diabetes Mellitus, Kidney diseases, Malignancy, Viral Hepatitis, Wilson disease Hemochromatosis, Cystic fibrosis and Autoimmune diseases Lack of using of any approved therapies known to have potential benefit in NAFLD control within the previous 3 months Lack of using of Hepatotoxic drugs within the past 6 months
Exclusion criteria:
Lack of Fatty Liver in Ultrasonography
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by computer randomization method using www.randomization.com Double_ blind
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Shiraz Universiry of Medical Siences, Zand Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶- ۷۱۳۴۸
Approval date
2019-06-05, 1398/03/15
Ethics committee reference number
IR.SUMS.REC.1398.891

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Liver steatosis
Timepoint
Previous of intervention and 3 months after of initiating of study
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
Malondialdehyde
Timepoint
Previous of intervention and 3 months after of initiating of study
Method of measurement
Analysis of serum samples

2

Description
Alanine aminotransferase
Timepoint
Previous of intervention and 3 months after initiating study
Method of measurement
Analysis of serum samples

3

Description
Aspartate aminotransferas
Timepoint
Previous of intervention and 3 months after of initiating study
Method of measurement
Analysis of serum samples

4

Description
Gama gluthamyl transpeptidase
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
Analysis os serum samples

5

Description
Lipid profile
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
Analysis of serum samples

6

Description
Fasting blood sugar
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
Analysis of serum samples

7

Description
Serum insulin
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
Analysis of serum samples

8

Description
HOMA- IR
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
( serum insulin × Fasting blood sugar) ÷ 405

9

Description
Wheight
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
Using scale (kg)

10

Description
BMI (Body mass index)
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
Wheight(kg) ÷ (Height (m) × Height (m) )

11

Description
Liver steatosis
Timepoint
Previous of intervention and 3 months after initiating of study
Method of measurement
Ultrasonography

Intervention groups

1

Description
Intervention group: Licorice root powder 1000 mg / day
Category
Treatment - Drugs

2

Description
Control group: Maltodextrin 1000 mg / day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid motahari clinic
Full name of responsible person
Dr Zohreh Mazloom
Street address
Shahid Motahari clinic, Zand Blvd, Nemazi sqr,, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۵۳۶-۷۵۵۴۱
Phone
+98 71 3725 1007
Email
Zohreh.mazloom@gmail.com

2

Recruitment center
Name of recruitment center
Imam reza clinic
Full name of responsible person
Dr Zohreh mazloom
Street address
Imam reza clinic, Zand Blvd, Nemazi Sqr, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۵۵۴۱_۷۱۵۳۶
Phone
+98 71 3725 1007
Email
Zohreh.Mazloom@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younos Ghasemi
Street address
Shiraz University of Medical Sciences, Zand Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۵-۱۹۷۸
Phone
+98 71 3235 7282
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Pouya Rostamizadeh
Position
Master of Science( MSc) of Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۵۳۶-۷۵۵۴۱
Phone
+98 71 3725 1007
Email
Pouyarostamizadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Mazloom
Position
Professor of nutrition sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۵۳۶-۷۵۵۴۱
Phone
+98 71 3725 1007
Email
Zohreh.mazloom@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pouya Rostamizadeh
Position
Master of Sciences ( MSc) of Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۵۳۶-۷۵۵۴۱
Phone
+98 71 3725 1007
Email
Pouyarostamizadeh@gmail.com

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
Nonexistence more information.
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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