The effects of berberis integerrima extract on liver enzymes, liver steatosis and fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) following the DASH diet: a double-blind randomized clinical trial.
60 patients with non-alcoholic fatty liver disease will be randomly assigned to intervention and control groups. In the intervention group, participants will receive a daily capsule of berberis integrimma extract (containing 320 mg of total anthocyanin). In the placebo group, people take a placebo capsule. The study period will be 12 weeks. A dose of 320 mg per day has been associated with improvement in inflammatory markers in previous studies. The DASH diet will be prescribed for both groups according to the characteristics of the participants. Also, to control participants in terms of taking supplements and placebo and prevent the samples from falling, the follow-up of patients would occur every two weeks by phone.
Participants/Inclusion and exclusion criteria
Entry criteria: age 18 years and older; diagnosis of the disease by ultrasound; ALT >30 IU/L in men and ALT >19 IU/L in women; BMI greater than 18.5 and less than 30.
Non-entry criteria: pregnancy or breastfeeding; alcohol consumption; history of diseases including liver cirrhosis; viral hepatitis; cardiovascular diseases; cancer; relapse and hospitalization of the patient; allergy to barberry.
Intervention groups
In the intervention group, people receive a daily capsule of barberry extract (containing 320 mg of total anthocyanin). In the placebo group, people take a placebo capsule. The study period will be 12 weeks. A dose of 320 mg per day has been associated with improvement in inflammatory markers in previous studies.
Main outcome variables
changes in the severity of liver steatosis; changes in the severity of liver fibrosis; Serum levels of liver enzymes (ALT, AST, ALP, GGT)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210427051098N6
Registration date:2024-02-03, 1402/11/14
Registration timing:prospective
Last update:2024-02-03, 1402/11/14
Update count:1
Registration date
2024-02-03, 1402/11/14
Registrant information
Name
Sayyed Saeid Khayyatzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
khayyatzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of berberis integerrima extract on liver enzymes, liver steatosis and fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) following the DASH diet: a double-blind randomized clinical trial.
Public title
The effects of berberis integerrima extract on the non-alcoholic fatty liver disease (NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and older
Diagnosis of the disease by ultrasound with a standard method
ALT >30 IU/L in men and ALT >19 IU/L in women
BMI higher than 18.5 and less than 30
Exclusion criteria:
Taking corticosteroids
Pregnancy and breastfeeding
Alcohol consumption (men: ethanol > 140 g per week, women: ethanol > 70 g per week)
History of diseases including liver cirrhosis, viral hepatitis, cardiovascular diseases, cancer
Medication history including corticosteroids, non-steroidal anti-inflammatory drugs, drugs affecting blood sugar, lipid profile, body weight and liver function.
Disease relapse and patient hospitalization
Barberry allergy
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation between two groups will perform using Random allocation version 2 software. The random sequence will generate with this software using a simple random allocation method, and each number will allocate to an intervention group A or B. Allocation concealment will perform by calling or sending message to a third-person who is unaware of intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators and data collectors will be blinded to the study groups. Allocation concealment will perform by calling or sending message to a third-person who is unaware of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
school of public health, shahid sadoughi university of medical sciences, Shohadaye gomnam Blvd, Alam Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Approval date
2023-11-20, 1402/08/29
Ethics committee reference number
IR.SSU.SPH.REC.1402.105
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease (NAFLD)
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Serum levels of alanine transaminase enzyme
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Enzymatic method
Secondary outcomes
1
Description
Severity of hepatic steatosis
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Fibroscan analysis
2
Description
Severity of liver fibrosis
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Fibroscan analysis
3
Description
Severity of liver stiffness
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Fibroscan analysis
4
Description
Controlled Attenuation Parameter (CAP)
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Fibroscan analysis
5
Description
Serum levels of aspartate aminotransferase
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Enzymatic method
6
Description
Serum levels of alkaline phosphatase
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Enzymatic method
7
Description
Serum levels of gammaglutamyltransferase
Timepoint
Before intervention- after intervention (12 weeks after receiving barberry extract or placebo)
Method of measurement
Enzymatic method
Intervention groups
1
Description
Intervention group: In the intervention group, participants will receive a daily capsule of barberry extract (containing 320 mg of total anthocyanin) for 12 weeks. The DASH diet will be prescribed for both groups according to their characteristics and individual requirements.
Category
Treatment - Other
2
Description
Control group: In the placebo group, participants will receive a placebo capsule with a similar appearance to the intervention capsules, for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mohammad Hossein Ahrarizdi's clinic
Full name of responsible person
sayyed saeid khayyatzadeh
Street address
Maryam Medical building, Maryam Alley, Kashani St., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3623 0765
Email
khayyatzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi abargouei
Street address
Central Administration, Bahonar Sq., Yazd 8916978477 Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd.. Alem square
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3820 9100
Fax
Email
khayyatzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd.. Alem square
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3820 9100
Fax
Email
khayyatzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd.. Alem square
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3820 9100
Fax
Email
khayyatzadeh@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
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
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