Protocol summary

Study aim
Evaluate the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease.
Design
Randomized clinical trials with control groups, parallel groups are performed on 42 patients.
Settings and conduct
In this study, adults with non-alcoholic fatty liver disease referred to Taleghani Hospital's Liver Clinic, who have the criteria to enter the study, if they desire to participate in this research with steatosis in ultrasound or fibroscan; general and activity questionnaires, anthropometric indicators are collected. At the beginning and end of the study, fibroscan and blood tests will be performed to evaluate the indicators.
Participants/Inclusion and exclusion criteria
People who desire to participate in the study with age 18-60 years and BMI above 20 who have evidence of non-alcoholic steatohepatitis in ultrasound or fibroscan and no history of alcohol consumption or Alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men in the absence of other chronic and acute liver diseases and disorders, biliary tract disease, autoimmune diseases, cancer and hereditary disorders affecting Liver status and liver cirrhosis, lack of pregnancy or lactation in women, and non-use of hepatotoxic drugs are included in the study, and if they do not want to continue studying or using hepatotoxic drugs during the study or non-compliance with the diet, they will be excluded.
Intervention groups
Each person is randomly assigned to a low free sugar diet or a regular diet group with a dietary recommendation based on the classification.
Main outcome variables
Hepatic fibrosis, and steatosis Lipid profile, Glycemic indices, Liver enzymes, Inflammatory factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100524004010N30
Registration date: 2020-06-11, 1399/03/22
Registration timing: registered_while_recruiting

Last update: 2020-06-11, 1399/03/22
Update count: 0
Registration date
2020-06-11, 1399/03/22
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
2019-07-23, 1398/05/01
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease
Public title
Evaluation of the effects of a low free sugar diet in patients with Nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in research Age 60-18 years BMI above 20 Evidence of non-alcoholic steatohepatitis (inflammation and swelling of hepatocytes) second and third degree in ultrasonography Evidence of non-alcoholic steatohepatitis in fibro-scan results with CAP Score over 263 Lack of a history of alcohol consumption or alcohol consumption less than 10 grams per day in women and less than 20 grams per day in men Lack of other chronic and acute liver diseases and disorders (hepatitis B, C, etc.), biliary disease, autoimmune diseases, cancer and hereditary disorders affecting the condition of the liver (iron, copper storage disease) and cirrhosis Lack of pregnancy or lactation in women No consumption of hepatotoxic drugs such as phenytoin, tamoxifen and lithium, and drugs that affect liver function
Exclusion criteria:
Lack of desire to continue research Forced to use antibiotics or hepatotoxic drugs during the study Non-compliance with low free sugar diet
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
In this study، in order to the randomization process، a simple randomization is used by using a table of random numbers. before beginning the study،each person is placed in one of the intervention or control groups based on a simple random division table. we have considered a two-digit code for the number of sample size numbers, and selected the start point by referring to the table, and based on the adjacent two-digit number, moved in the direction of the row, and we choose the first two-digit number less than 50 as the first sample and we'll continue to do this until the samples reach 50.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the National Institute of Nutritional Research and Food Industry
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1399.011

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
ICD-10 code description
low free sugar diet, lipid profile, glycemic indices, liver enzymes, inflammatory factors, hepatic steatosis , fibrosis , patients with Nonalcoholic fatty liver disease

Primary outcomes

1

Description
Hepatic steatosis, Liver fibrosis
Timepoint
At the first and at the 12th week of the study
Method of measurement
Fibroscan

Secondary outcomes

1

Description
Weight
Timepoint
At the first , 6th and 12th week of the study
Method of measurement
Scale

2

Description
BMI
Timepoint
At the first , 6th and 12th week of the study
Method of measurement
Calculate

3

Description
Waist to hip ratio
Timepoint
At the first , 6th and 12th week of the study
Method of measurement
Calculate

4

Description
liver enzymes (AST,ALT,GGT)
Timepoint
At the first and at the 12th week of the study
Method of measurement
Enzymatic method

5

Description
lipid profile (TG,Total cholesterol,LDL-C,HDL-C)
Timepoint
At the first and at the 12th week of the study
Method of measurement
Enzymatic method

6

Description
FBS
Timepoint
At the first and at the 12th week of the study
Method of measurement
Enzymatic method

7

Description
Insulin
Timepoint
At the first and at the 12th week of the study
Method of measurement
Radioimmunoassay

8

Description
hs-CRP
Timepoint
At the first and at the 12th week of the study
Method of measurement
ELISA

9

Description
TNF-α
Timepoint
At the first and at the 12th week of the study
Method of measurement
ELISA

10

Description
NF-κB
Timepoint
At the first and at the 12th week of the study
Method of measurement
ELISA

11

Description
HOMA-IR
Timepoint
At the first and at the 12th week of the study
Method of measurement
Calculate

12

Description
QUICKI
Timepoint
At the first and at the 12th week of the study
Method of measurement
Calculate

Intervention groups

1

Description
Intervention group: a low free sugar diet with dietary and physical activity recommendations/12 weeks
Category
Lifestyle

2

Description
Control group: Dietary and physical activity recommendations/12 weeks
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology and Liver Clinic of Taleghani Hospital
Full name of responsible person
Azita Hekmatdoost
Street address
Tabnak St. Velenjak Region, Chamran High Way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2235 7484
Email
a_hekmat2000@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Hekmatdoost
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
azita hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
azita hekmatdoost
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
a_hekmat2000@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
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