CYP2C19 Genetic Variants
Conditions
Brief summary
The investigators will examine whether a non-invasive screening tool for CYP2C19 genetic variants can be developed by measuring limonene metabolism.
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.
Interventions
DIETARY_SUPPLEMENTLimonene
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.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
We are using quantitative assays for this study which reduce the need for masking of the participant or investigator.
Intervention model description
Human volunteers participating in this study will be given an over the counter orange peel extract and limonene levels will be measured.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath limonene value in parts per billion | 2 hours | The amount of limonene in the breath will be measured by mass spectrometry for each participant. |
Countries
United States
Contacts
Primary ContactEric Gross, MD/PhD
Outcome results
None listed