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Effects of daily consumption of barberry juice on the status of liver tests and markers of oxidative stress in healthy people

Protocol summary

Summary
This interventional, non-randomized research will study the effects of barberry syrup on antioxidant biomarkers, oxidative stress, and liver enzymes in the personnel of Birjand University of Medical Sciences. A total of 20 healthy, non-smokers and non-alcohol- abusers, irrespective of sex, aged between 20 and 40 years, who have not used antibiotics from two weeks to the study, will be incorporated informedly and voluntarily. Recruitment will occur in one center and there is no blinding. In case a participant uses antibiotics, smokes or consumes alcohol during the study, s/he will be excluded. Twenty-four hours before the intervention, blood samples will be collected before and after drinking barberry syrup at different times ( 1, 3, 6 and 8 hours later); urine samples will also be collected after 8, 12 and 24 hours of drinking the syrup. Then, in a two-week period, each of the participants will take a full glass (240 cc) of fresh barberry juice (equivalent to 1.74g/240 ml gallic acid and 0.745 g/240 ml berberine phenolic compounds). At the end of the first and second weeks of intervention, blood and urine samples will be collected again. Blood samples will be used to measure oxidative stress indices (Ferric Reducing Ability of Plasma (FRAP), Thiobarbituric acid reactive substances (TBARS), and liver function tests will include enzyme (ALT, AST, ALK) and bilirubin tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101517756N9
Registration date: 2016-10-31, 1395/08/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research, Birjand University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2016-11-28, 1395/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of daily consumption of barberry juice on the status of liver tests and markers of oxidative stress in healthy people
Public title
Effects of barberry consumption on liver function and antioxidant capacity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: university employee, age between 20 and 40, lack of a specific disease or use of antibiotics since two weeks from the study onset, non-use of alcohol or smoking, provision of informed consent; Exclusion criteria: suffering from a disease during the study, consumption of antibiotics and/or alcohol, or smoking during the study
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sceinces
Street address
Vice-chancellery for Research, Birjand University of Medical Sceinces, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2016-04-27, 1395/02/08
Ethics committee reference number
ir.bums.1395.2

Health conditions studied

1

Description of health condition studied
liver disease
ICD-10 code
k71
ICD-10 code description
Toxic liver disease

Primary outcomes

1

Description
Antioxidant level
Timepoint
Before, 7 dats and 14 days after intervention
Method of measurement
Ferric Reducing Ability of Plasma (FRAP), Thiobarbituric acid reactive substances (TBARS)

2

Description
liver enzymes
Timepoint
Before, 7 dats and 14 days after intervention
Method of measurement
ALT, AST, ALK and bilirubin tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: A full glass of barberry syrup (240 cc, equivalent to 1.74g/240 ml gallic acid and 0.745 g/240 ml berberine phenolic compounds) used on a daily basis for 2 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center of Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research of Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Vice Chancellery for Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research of Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohadeseh Abolhasannezhad
Position
Master of Science in Food Science and Industries
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
m_abolhasannezhad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Position
Associate Professor in Biochemistry
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
azarban@bums.ir.ac
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate of Translation
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
mbroozgar@BUMS.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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