Determining the effect of jujube on anthropometric, biochemical and hepatic steatosis predictors indices in patients with non alcoholic fatty liver disease
Design
The current study is a phase 3 single-blind controlled clinical trial with two parallel groups (intervention and control). ّForty-four eligible patients will be randomly assigned to each group (88 participants in total)
Settings and conduct
Eighty eight eligible patients who referred to Hazrat Abolfazl Hospital in Kermanshah are randomly assigned to 2 study groups. Intervention group will receive 30 gr jujube powder along with a low-calorie diet(500 Kcal reduction) for12 weeks. Control group will receive a low-calorie diet(500 Kcal reduction) for12 weeks. Anthropometrics indices, biochemical and hepatic steatosis predictors indices, will be assessed before and after the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosed patients with nonalcoholic fatty liver, not abusing alcohol, not having diabetes, kidney disorders and other liver diseases,
Not having liver cancer, or other cancers, not having allergy to Jujube and not taking multivitamins and minerals supplements in 3 month ago. Exclusion criteria:Pregnancy .
Intervention groups
The intervention group will consume 30 grams of jujube powder (Shaina Sharq Jujube company) daily, for 12 weeks. All the patients (intervention and control groups)will be given a low-calorie diet (500 Kcal reduction).
Main outcome variables
FBS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140502017522N5
Registration date:2023-06-07, 1402/03/17
Registration timing:prospective
Last update:2023-06-07, 1402/03/17
Update count:0
Registration date
2023-06-07, 1402/03/17
Registrant information
Name
Maryam Taghdir
Name of organization / entity
Baqiyatallah University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 5511
Email address
mtaghdir@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-01-19, 1402/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of jujube on anthropometric , biochemical and hepatic steatosis predictors indices in patients with non-alcoholic fatty liver disease
Public title
The effect of jujube in management patients with non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosed patients with nonalcoholic fatty liver
not abusing alcohol
not having diabetes, kidney disorders and other liver diseases
Not having liver cancer, or other cancers
not having allergy to Jujube
not taking multivitamins and minerals supplements during 3 month ago
Exclusion criteria:
pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done using the block randomization method (block size= four). The possible blocks will be as follows:1- AABB, 2- ABAB، 3- BABA ، 4- BBAA، 5- BAAB، 6- ABBA
Then, numbers (1 to 6) will be randomly selected using the random number table, and this process will be repeated 22 times until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor and data analyser will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commmittee of Baqiyatallah Hospital
Street address
Baqiyatallah university, south sheikh bahai st, molasdra st, vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.010
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
Fasting blood sugar (FBS)
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Standard enzymatic method
Secondary outcomes
1
Description
Weight
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
scale
2
Description
Waist circumference
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
tape measure
3
Description
Body mass index
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Standard formula
4
Description
Aspartate aminotransferase (AST)
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Enzyme-linked immuno_sorbent assay (ELISA)
5
Description
Total cholesterol
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Standard enzymatic method
6
Description
high density lipoprotein
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Standard enzymatic method
7
Description
low density lipoprotein
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Standard enzymatic method
8
Description
triglyceride
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Standard enzymatic method
9
Description
hepatic steatosis index(HS index)
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
standard formula
10
Description
fatty liver index(FL index)
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
standard formula
11
Description
triglyceride glucose index(TYG index)
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
standard formula
12
Description
Alanin amino transferase
Timepoint
At the beginning of the study and after the intervention (12 weeks after the start of the intervention)
Method of measurement
Enzyme linked immuno sorbent assay(ELISA)
13
Description
Gamma-glutamyl transferase (GGT)
Timepoint
At the beginning of the study (before the intervention) and the end of the study (12 weeks after the intervention)
Method of measurement
Enzyme linked immuno sorbent assay(ELISA)
Intervention groups
1
Description
Intervention group: Daily intake of 30 grams of jujube powder(Shaina Sharq Jujube company) ) for 12 weeks along with a low-calorie diet (500 kcal reduction)
Category
Treatment - Other
2
Description
Control group: Following a low-calorie diet (reduction of 500 kcal of energy intake) recommended by the researcher for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat bolfazl Hospital
Full name of responsible person
Ronak Borzoei
Street address
gomrok st
City
kermanshah
Province
Kermanshah
Postal code
6715715516
Phone
+98 83 2182 4025
Email
ronakborzooie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abbas Ali Imani Fooladi
Street address
baqiatala university south sheikh baha st, molasadra, st , vanak sq.
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8855 5125
Email
imanifouladi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ronak Borzoei
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Gomrok Street
City
Kermanshah
Province
Kermanshah
Postal code
7155166715
Phone
+98 83 2182 4025
Email
ronakborzooie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Maryam Taghdir
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Baqiatallah University, South Sheikh Baha'i st., Molasadra st., Vanak sq.,
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5511
Email
mtaghdir@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ronak Borzoei
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
gomrok st
City
kermanshah
Province
Kermanshah
Postal code
6715715516
Phone
+98 83 2182 4025
Email
ronakborzooie@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