CYP2C19 Variants and Limonene Metabolism

NCT05078723 | Recruiting

• 1 other identifier: 59978
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CYP2C19 Genetic Variants

Outcome Measures

Primary Outcomes (1)

• Breath limonene value in parts per billion

  The amount of limonene in the breath will be measured by mass spectrometry for each participant.

  2 hours

Study Arms (2)

CYP2C19*2 and CYP2C19*3 Variants

EXPERIMENTAL

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.

Dietary Supplement: Limonene

Wildtype CYP2C19

EXPERIMENTAL

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.

Dietary Supplement: Limonene

Interventions

Limonene DIETARY_SUPPLEMENT

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.

CYP2C19*2 and CYP2C19*3 Variants; Wildtype CYP2C19

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range: Greater than 18 years and less than 45 years.
• Gender: Male or Female
• Ethnicities: East Asian

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Interventions

Limonene

Intervention Hierarchy (Ancestors)

Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Monoterpenes; Terpenes

Central Study Contacts

Eric Gross, MD/PhD

CONTACT

(650)721-4521; ergross@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: We are using quantitative assays for this study which reduce the need for masking of the participant or investigator.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Human volunteers participating in this study will be given an over the counter orange peel extract and limonene levels will be measured.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: October 14, 2021
• Study Start: October 30, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)