Effect of combined dietary weight loss and cranberry supplementation on hepatic enzymes, steatosis and inflammatory, antioxidant and apoptosis biomarkers in patients with Non-alcoholic fatty liver disease
the aim of this study is to determine the effect of combined dietary weight loss and cranberry supplementation on hepatic enzymes, steatosis and inflammatory, antioxidant and apoptosis biomarkers in patients with Non-alcoholic fatty liver disease.
Design
50 patients will be recruited. patients will be divided into two groups to take combined dietary weight loss and 2 capsules containing 288 mg Cranberry extract or placebo starch powder for 12 weeks. Randomization will be done using Blocked Randomization.
Settings and conduct
This randomized doubleblind, placebo-controlled, clinical trial will be conducted in Ahvaz Golestan hospital, Iran.
Participants/Inclusion and exclusion criteria
inclusion criteria: adult patients who were 18 years or older; evidence of NAFLD with a steatosis grade higher or equal to 2 in ultrasonography; serum alanine aminotransferase(ALT) greater than 30 IU/L formen and greater than19 IU/L for women; Body mass index (BMI) Between 25 and 35
no history of alcohol consumption or consumption of less than 10 g of alcohol per day in women and less than 20 g/d in men; absence of other liver disorders, cardiovascular, respiratory, and kidney disorders; absence of pregnancy or lactation; absence of weight loss in the previous 3 months; and absence of endocrine and metabolism disorders.
Intervention groups
This is a randomized doubleblind, placebo-controlled, clinical trial.
Intervention group: dietary weight loss and 2 capsules containing 288 mg Cranberry extract for 12 weeks
Control group: dietary weight loss and 2 placebo capsules for 12 weeks
Main outcome variables
Fatty liver grade
(Liver steatosis)
ALT
AST
ALP
Monocyte chemoattractant protein 1 (Mcp-1)) یا CCL2
Citoceratine 18
Total antioxidant body (TAC)
Malondialdehyde
TNFα
Lipid profile
Fasting blood sugar
Insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150124020765N2
Registration date:2019-01-06, 1397/10/16
Registration timing:registered_while_recruiting
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Razie Hormoznejad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 146 0816
Email address
hormozi.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-04-23, 1398/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined dietary weight loss and cranberry supplementation on hepatic enzymes, steatosis and inflammatory, antioxidant and apoptosis biomarkers in patients with Non-alcoholic fatty liver disease
Public title
Effect of combined dietary weight loss and cranberry supplementation on Non-alcoholic fatty liver disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
adult patients who were 18 years or older
evidence of NAFLD with a steatosis grade higher or equal to 2 in ultrasonography
serum alanine aminotransferase(ALT) greater than 30 IU/L formen and greater than19 IU/L for women
Body mass index (BMI) Between 25 and 35
Exclusion criteria:
history of alcohol consumption or consumption of more than 10 g of alcohol per day in women and more than 20 g/d in men;
Pregnancy or lactation
History of other liver disorders,malignancies, cardiovascular, respiratory, and kidney disorders;
Weight loss in the previous 3 months
History of endocrine and metabolism disorders.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study; we assume equal allocation of subjects to each group With blocked randomization. With a randomized block design, the experimenter divides subjects in to subgroups called blocks, such that the variability within blocks is less than the variability between blocks. Then, subjects within each block are randomly assigned to treatment conditions.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researchers blind to the type of supplement
given to each patient. A third party keep the
identities of the subjects and which group (cranberry
or placebo) they belong to, which are not revealed
to researchers until the end of study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-12-08, 1397/09/17
Ethics committee reference number
IR.AJUMS.REC.1397.678
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
Fatty liver grade (Steatosis)
Timepoint
At baseline and after 12 weeks
Method of measurement
ultrasonography
2
Description
Alanine transaminase
Timepoint
At baseline and after 12 weeks
Method of measurement
enzymatic colorimetric assay
3
Description
Aspartate aminotransferase
Timepoint
At baseline and after 12 weeks
Method of measurement
Enzymatic colorimetric assay
4
Description
Alkaline phosphatase
Timepoint
At baseline and after 12 weeks
Method of measurement
Enzymatic colorimetric assay
5
Description
Monocyte chemoattractant protein 1 (Mcp-1)) یا CCL2
Timepoint
At baseline and after 12 weeks
Method of measurement
Elisa kit
6
Description
ytokeratin-18
Timepoint
At baseline and after 12 weeks
Method of measurement
Elisa kit
7
Description
Total antioxidant body
Timepoint
At baseline and after 12 weeks
Method of measurement
Elisa kit
8
Description
Malondialdehyde
Timepoint
At baseline and after 12 weeks
Method of measurement
Elisa kit
9
Description
Tumor necrosis factor alpha
Timepoint
At baseline and after 12 weeks
Method of measurement
Elisa kit
10
Description
Lipid profile
Timepoint
At baseline and after 12 weeks
Method of measurement
Elisa kit
11
Description
Insulin
Timepoint
At baseline and after 12 weeks
Method of measurement
Elisa
12
Description
Fasting blood sugar
Timepoint
At baseline and after 12 weeks
Method of measurement
Enzymatic colorimetric assay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: dietary weight loss and 2 capsules containing 288 mg Cranberry extract for 12 weeks
Category
Other
2
Description
Control group: dietary weight loss and 2 placebo capsules for 12 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz golestan hospital
Full name of responsible person
Razie Hormoznejad
Street address
Golestan hospital, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3777
Fax
Email
r_hormozi68@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
dr Mohammad Badavi
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3331 1159
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Razie Hormoznejad
Position
Nutrition phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 33333777
Email
r_hormozi68@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razie Hormoznejad
Position
Nutrition Ph.d student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311
Email
hormozi.r@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razie Hormoznejad
Position
Nutrition ph.d student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311
Email
r_hormozi68@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The results of this clinical trial will be published as an article after the end of the study
When the data will become available and for how long
Not specified
To whom data/document is available
Not specified
Under which criteria data/document could be used
An article
From where data/document is obtainable
Not specified
What processes are involved for a request to access data/document