CYP2C19 Variants and Limonene Metabolism

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05078723
Status
Recruiting

Conditions

  • CYP2C19 Genetic Variants

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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.

Study Details

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

Key Dates

Start date
Oct 30, 2021
Status verified
Dec 2024
Primary completion
Mar 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Breath limonene value in parts per billion [ Time Frame: 2 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford School of MedicineStanfordCalifornia94305
Eric Gross, MD/PhD

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