CYP2C19 Variants and Limonene Metabolism

Stanford University

Status: Enrolling

Conditions: CYP2C19 Genetic Variants

Treatments: Dietary Supplement: Limonene

Study type: Interventional

Funder types: Other

Identifiers

NCT05078723

59978

Details and patient eligibility

About

The investigators will examine whether a non-invasive screening tool for CYP2C19 genetic variants can be developed by measuring limonene metabolism.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CYP2C19*2 and CYP2C19*3 Variants

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Limonene

Wildtype CYP2C19

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Limonene