Evaluation of the effect of fruit rich diet on liver steatosis, liver enzymes, insulin resistance, lipid profile, and anthropometric measurements in patient with non alcoholic fatty liver disease
Determination of the effect of fruit rich diet on hepatic steatosis, liver enzymes, insulin resistance, lipid profile and anthropometric indices in patients with non-alcoholic fatty liver.
Design
Not blinded randomized clinical trial with control group, with parallel design, on 70 patients, the Stratified Block Randomization program was used for randomization.
Settings and conduct
The study will be performed on patients with non-alcoholic fatty liver referred to the gastrointestinal clinic at Imam Khomeini Hospital in Urmia. 35 patients were randomly assigned to each group.The intervention group along with the usual treatment will be recommended to consume at least 4 serving of fruit per day and the control group in addition to the usual treatment will be recommended to consume no more than 2 serving of fruit per day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Age: more than 18 years of both sexes
2) BMI less than 30 kg per square meter
3) Patient with grade 2 and 3 non-alcoholic fatty liver disease, which is diagnosed by ultrasound.
Exclusion criteria:
Having special diets
Pregnancy and lactation during the study
Viral hepatitis
Intervention groups
The intervention group will be advised to consume at least 4 serving of fruit per day and the control group will be advised to consume no more than 2 serving of fruit per day.
Main outcome variables
Determination of the effect of fruit rich diet on hepatic steatosis, liver enzymes, insulin resistance, lipid profile and anthropometric indices in patients with non-alcoholic fatty liver disease.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201010048982N1
Registration date:2020-10-15, 1399/07/24
Registration timing:registered_while_recruiting
Last update:2020-10-15, 1399/07/24
Update count:0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
Farkhondeh Alami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3333 7906
Email address
far.alami28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of fruit rich diet on liver steatosis, liver enzymes, insulin resistance, lipid profile, and anthropometric measurements in patient with non alcoholic fatty liver disease
Public title
Effect of fruit rich diet in patient with non alcoholic fatty liver disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
BMI less than 30 kg per square meter
Patient with grade 2 and 3 non-alcoholic fatty liver disease, which is diagnosed by ultrasound
Exclusion criteria:
Having special diets
Pregnancy and lactation during the study
Viral hepatitis
Alcohol consumption
Diabetes mellitus
Psychopathy
Failure to follow the fruit consumption according to our recommendations during the study
Untreated hypothyroidism
Kidney disease
Taking medications that can increase GGT levels
Heart failure and bone disease
Deficiency of alpha-1 antitrypsin
Digestive diseases
Smoking
Menopause
Age
From 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After controlling the inclusion and exclusion criteria, participants will be randomly assigned and matched in two groups based on non-alcoholic fatty liver grade, age and sex by using the Stratified Block Randomization program.
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
Urmia university of medical sciences
Street address
Resalat Street, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
IR.UMSU.REC.1398.535
Health conditions studied
1
Description of health condition studied
Non- alcoholic fatty liver disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hepatic steatosis, liver enzymes, insulin resistance, lipid profile and anthropometric indices
Timepoint
6 months
Method of measurement
Biochemical measurements, ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group, along with the usual treatment, will be recommended to consume at least 4 serving of fruit per day.
Category
Lifestyle
2
Description
Control group: In addition to the usual treatment, it will be recommended that their daily fruit consumption should not exceed 2 serving.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Kamran Shateri
Street address
Ayatollah Modarres Blvd., Ershad St.
City
Urmia
Province
West Azarbaijan
Postal code
57157 81351
Phone
+98 44 3346 9931
Email
far.alami28@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Farkhondeh Alami
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
far.alami28@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Farkhondeh Alami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Zakir St., Bustan Girls' Dormitory
City
Urmia
Province
West Azarbaijan
Postal code
5614687911
Phone
+98 44 3383 0300
Email
Far.alami28@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Urmia university of medical Sciences, School of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3277 0698
Email
alizadeh85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Urmia university of medical sciences, School of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3227 0698
Email
Alizadeh85@yahoo.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
Preservation of patient 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
Undecided - It is not yet known if there will be a plan to make this available