Recruiting

Limonene Metabolism

Sponsor:

Stanford University

Code:

NCT05078723

Conditions

CYP2C19 Genetic Variants

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Limonene

Study Details

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

Study ID

NCT05078723

Start date

Oct 30, 2021

Status verified date

Dec, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Limonene

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eric Gross, MD/PhD

(650)721-4521ergross@stanford.edu

Locations

Stanford School of Medicine

Recruiting

Stanford, California, United States, 94305

More Information

Sponsor

Stanford University

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-12-16.