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Recruiting

NCT Number: NCT05078723

CYP2C19 Variants and Limonene Metabolism

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

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford School of Medicine

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Eric Gross, MD/PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Breath limonene value in parts per billion

    Time frame: 2 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Gross, MD/PhD

CONTACT

[email protected]

(650)721-4521

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Functional Consequences of CYP2C19 Variants on Limonene Metabolism in Humans

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 14, 2021
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.