- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078723
CYP2C19 Variants and Limonene Metabolism
November 27, 2023 updated by: Eric Gross, Stanford University
Functional Consequences of CYP2C19 Variants on Limonene Metabolism in Humans
The investigators will examine whether a non-invasive screening tool for CYP2C19 genetic variants can be developed by measuring limonene metabolism.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Cytochrome P450 2C19 is an important enzyme that metabolizes many drugs.
However, individuals with genetic variants of CYP2C19, such as CYP2C19*2 and CYP2C19*3, are poor metabolizers of these drugs.
Therefore, it is of interest to determine whether the investigators can develop a non-invasive assay to identify genetic variants of CYP2C19 by using a substrate for CYP2C19 found in citrus fruit, limonene.
The purpose of the study is to examine changes in limonene levels in human breath after drinking orange peel extract for people with CYP2C19*2 and CYP2C19*3 genetic variants versus those that do not.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric Gross, MD/PhD
- Phone Number: (650)721-4521
- Email: ergross@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford School of Medicine
-
Contact:
- Eric Gross, MD/PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age range: Greater than 18 years and less than 45 years.
- Gender: Male or Female
- Ethnicities: East Asian
Exclusion Criteria:
- Pregnant and/or Breastfeeding
- previous allergic reaction to limonene, citrus fruits, bovine gelatin, glycerin
- past medical history of cerebrovascular or cardiovascular disease
- veganism
- history of chest pain or shortness of breath in the past month
- certain medications that are CYP2C19 substrates or CYP2C19 inhibitors
- Non-East Asian descent
- age less than 18 y.o or age greater than 45 y.o
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CYP2C19*2 and CYP2C19*3 Variants
The group of participants has been genotyped to have the CYP2C19*2 and/or CYP2C19*3 variant during the first part of the study.
The participants will consume 1 oz water mixed with 500mg limonene (Jarrow Formula orange peel extract) and be asked to swish 5 times and swallow.
All participants will then provide breath samples over the course of 2 hours.
The breath sample outcomes will be compared to those of the wild-type CYP2C19 study subjects.
|
The investigators will ask the participants to swish 5 times and swallow 1 oz water mixed with 500mg limonene (Jarrow Formula orange peel extract).
The participant will be monitored for a total of 2 hours.
Breath samples will be acquired at a total of 11 time points throughout the study.
Measurements include 2 baseline measurements followed by the orange peel extract consumption.
|
Experimental: Wildtype CYP2C19
The group of participants has been genotyped to have wild-type CYP2C19.
The participants will consume 1 oz water mixed with 500mg limonene (Jarrow Formula orange peel extract) and be asked to swish 5 times and swallow.
All participants will then provide breath samples over the course of 2 hours.
The breath sample outcomes will be compared to those of the CYP2C19*2 and/or CYP2C19*3 study subjects.
|
The investigators will ask the participants to swish 5 times and swallow 1 oz water mixed with 500mg limonene (Jarrow Formula orange peel extract).
The participant will be monitored for a total of 2 hours.
Breath samples will be acquired at a total of 11 time points throughout the study.
Measurements include 2 baseline measurements followed by the orange peel extract consumption.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breath limonene value in parts per billion
Time Frame: 2 hours
|
The amount of limonene in the breath will be measured by mass spectrometry for each participant.
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2021
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
July 1, 2021
First Submitted That Met QC Criteria
October 12, 2021
First Posted (Actual)
October 14, 2021
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 59978
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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