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Investigation of the effect of piperine supplement on anthropometric indices, ultrasonographic findings, biochemical parameters and quality of life in patients with nonalcoholic fatty liver disease

Protocol summary

Study aim
The aim of this study is to evaluate of the effect of piperine supplement on on anthropometric indices, ultrasonographic findings, biochemical parameters and quality of life in patients with nonalcoholic fatty liver disease.
Design
64 patients with fatty liver after taking informed consent including 32 patients in case group and 32 patients in control group will be conducted parallel double blinded in the trial.
Settings and conduct
The trial will be performed in Tabriz Emam Reza hospital clinic by managing study and control groups. Piperine supplement(5mg) and placebo will be administered dayily for 12 weeks, while patients and physician are blind in the study. Lab tests and liver ultrasonography will be obtained and documented when referring patients to the clinic on schedules and at the end, by using the computer software the data will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Grade 2 and 3 non-alcoholic fatty liver ALT levels upper than 1.5 times the normal upper limit Exclusion criteria are: Chronic liver disease, diabetes, malignancy, hereditary diseases that affect the liver such as iron and copper storage disorder, untreated hypothyroidism, autoimmune disease, pregnancy, lactation, alcoholic fatty liver disease, consumption Alcohol, hepatitis Hypolipidemic and anti-inflammatory agents Bariatrics surgery in last year 43/5000Heavy diet to lose weight in the last 3 months Increase in fatty liver grade grade based on ultrasonographic findings during the study period Weight loss more than 10% during the study Discontent to continuation the study Not taking more than 10% of supplement
Intervention groups
In case group 5 mg of Piperine supplement daily for the three months will be prescribed and the control group will take placebo in same duration.
Main outcome variables
Fatty Liver Grading, Quality of Life, NAFLD Fibrosis Score، Fatty Liver Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180802040678N2
Registration date: 2019-08-13, 1398/05/22
Registration timing: registered_while_recruiting

Last update: 2019-08-13, 1398/05/22
Update count: 0
Registration date
2019-08-13, 1398/05/22
Registrant information
Name
Masoud Nouri-Vaskeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3325 9778
Email address
mnvaskeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of piperine supplement on anthropometric indices, ultrasonographic findings, biochemical parameters and quality of life in patients with nonalcoholic fatty liver disease
Public title
Effect of piperine supplement in patients with non alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 2 and 3 non-alcoholic fatty liver ALT levels upper than 1.5 times the normal upper limit
Exclusion criteria:
Chronic liver disease, diabetes, malignancy, hereditary diseases that affect the liver such as iron and copper storage disorder, untreated hypothyroidism, autoimmune disease, pregnancy, lactation, alcoholic fatty liver disease, consumption Alcohol, hepatitis Hypolipidemic and anti-inflammatory agents Bariatrics surgery in last year 43/5000Heavy diet to lose weight in the last 3 months Increase in fatty liver grade grade based on ultrasonographic findings during the study period Weight loss more than 10% during the study Discontent to continuation the study Not taking more than 10% of supplement
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data and Safety Monitoring Board
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomizing by computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants-healthcare provider-data collectors
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.TBZMED.REC.1398.291

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
Fattly Liver Grading
Timepoint
Before and after intervention
Method of measurement
Ultrasonography

2

Description
Quality of Life
Timepoint
Before and after intervention
Method of measurement
SF-36, CLDQ, and Disease Symptom Index 2.0 questionnaires

3

Description
Anthropometric indices
Timepoint
Before and after intervention
Method of measurement
Body weight and Body Mass Index

4

Description
Biochemical parameters
Timepoint
Before and after intervention
Method of measurement
Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Bilirubin Total and Direct, Fasting Blood Suger, Triglyceride, LDL, HDL, VLDL, Hs-CRP, Total Cholesterol, Albumin, Count Blood Cells, HbA1C, HOMA-IR, Fecal Calprotectin

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Administration of Piperine 5mg supplement daily for three months
Category
Treatment - Drugs

2

Description
Control group: Administration of placebo for three months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Leila Alizadeh
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 7314
Email
alizadele@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 7314
Email
medfa@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Nouri-Vaskeh
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3325 9778
Email
mnvaske@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Alizadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41333354844
Email
alizadele@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naser Hataminia
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 4844
Email
naser.hatamynia@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Information about the study is available upon approval by the University's Ethics Committee.
When the data will become available and for how long
Starting access 6 months after publication of data
To whom data/document is available
Everybody
Under which criteria data/document could be used
Using is not authorized
From where data/document is obtainable
Applicants must send their request to the author
What processes are involved for a request to access data/document
Sending the request via e-mail
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