Protocol summary

Summary
Piperine, the main alkaloid of black pepper, involves to activity of liver enzymes, including CYP1A2. Caffeine is primarily metabolized by this enzyme, so that the Saliva concentration of the drug is a criterion of CYP1A2 activity. Healthy volunteers are recruited. The main inclusion criteria are general health status, age between 18 to 35, no taking of enzyme inhibitor or inducer drugs and food enriched of black pepper as additive. And exclusion criteria are each chronic or metabolic disorders, and taking enzyme inhibitors and inducers. Crossover study to be carried out with one month period as wash out time. Healthy volunteer regardless gender, are randomly divided into two control and piperine receiving groups (n=20). The subject will receive placebo or piperine (1 capsule daily for 3 days before Caffeine) and Caffeine (10 mg as an oral single dose on fourth day of the study. Total period of the study is 4 days. Blood samples will be taken at 0, 0.5, 2.5 and 5 hr after Caffeine administration. The Caffeine Saliva concentration will be assayed using HPLC method. Pharmacokinetic parameters such as Saliva concentrations, clearance, half-life and volume of distribution of Caffeine in the placebo will be compared with the findings of piperine group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201209239271N3
Registration date: 2012-10-05, 1391/07/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-10-05, 1391/07/14
Registrant information
Name
Ali Akbar Moghadamnia
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1222 9591
Email address
a.moghadamnia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Affairs of Babol University of Medical Sciences
Expected recruitment start date
2012-10-21, 1391/07/30
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of piperine on the salivary concentration of caffeine as a main CYP1A2 probe
Public title
Piperine effect on caffeine salivary concentration
Purpose
Basic scienece
Inclusion/Exclusion criteria
After providing adequate information to the subjects, eligible healthy volunteer will be enrolled in the study. Inclusion criteria: be healthy; normal diet; not receiving microsomal enzyme inhibitor or inducer agents for at least 7 days before the study; not using black pepper for at least 7 days before the study; not using caffeine containing product 48 h before the study. Exclusion criteria: age below 18 and above 35; smoking; pregnancy; metabolic disorders; high pepper diet, receiving enzyme inhibitors or inducers.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
University Sq, Ganje Afrooze Ave.
City
Babol
Postal code
4717641367
Approval date
2011-12-31, 1390/10/10
Ethics committee reference number
5337/30/پ

Health conditions studied

1

Description of health condition studied
Pharmacokinetics
ICD-10 code
Z00
ICD-10 code description
General examination and investigation of persons without complaint and reported diagnosis

Primary outcomes

1

Description
Caffeine Saliva Concentration
Timepoint
Only once in fourth day of the study 0, 0.5, 2.5 and 5 h after taking Caffeine
Method of measurement
Using HPLC method (reverse phase; Water 25, Methanol 75, flow rate 0.8 ml/min, maximum wave length 242 nm)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: administration placebo one capsule daily for three days before Caffeine (50 mg oral single dose).
Category
Other

2

Description
Piperine group: administration piperine (15 mg) one capsule daily for three days before Caffeine (50 mg oral single dose).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Street address
Department of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganje Afrooze Ave. University SQ.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Position
PhD
Other areas of specialty/work
Street address
Deopartment of Pharmacology, Faculty of Medicine
City
Babol
Postal code
4717641367
Phone
+98 11 1219 2033
Fax
Email
moghadamnia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Ali AKbar Moghadamnia
Position
PharmD, PhD
Other areas of specialty/work
Street address
Department of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Phone
+98 11 1219 2033
Fax
Email
a.moghadamnia@mybabol.ac.irmoghadamnia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Position
PharmD, PhD
Other areas of specialty/work
Street address
Department of Pharmacology, Faculty of Medicine, Babol University of Medical Sciences, Ganje Afrooze Ave,
City
Babol
Postal code
4717641367
Phone
+98 11 1219 2033
Fax
Email
moghadamnia@gmail.com
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
empty
Analytic Code
empty
Data Dictionary
empty
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