Examining how limonene metabolism relates to CYP2C19 genetic variants
Functional Consequences of CYP2C19 Variants on Limonene Metabolism in Humans
NA · Stanford University · NCT05078723
This study is testing if measuring how limonene from orange peel extract is processed in the body can help identify genetic differences in a specific enzyme among young adults of East Asian descent.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05078723 on ClinicalTrials.gov |
What this trial studies
This study investigates the development of a non-invasive screening tool to identify genetic variants of the CYP2C19 enzyme by measuring limonene metabolism. Participants will consume orange peel extract, and changes in limonene levels in their breath will be analyzed to differentiate between individuals with specific CYP2C19 variants and those without. The study focuses on individuals aged 18 to 45 of East Asian descent, as they are more likely to carry these genetic variants. The goal is to improve the understanding of drug metabolism in relation to genetic differences.
Who should consider this trial
Good fit: Ideal candidates for this study are East Asian individuals aged between 18 and 45 years.
Not a fit: Patients outside the specified age range, non-East Asian descent, or with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a simple breath test for identifying individuals at risk of poor drug metabolism due to CYP2C19 genetic variants.
How similar studies have performed: While the approach of using limonene metabolism for genetic screening is novel, similar studies have explored genetic variants and drug metabolism with varying success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stanford, California
- Stanford School of Medicine — Stanford, California, United States (RECRUITING)
Study contacts
- Study coordinator: Eric Gross, MD/PhD
- Email: ergross@stanford.edu
- Phone: (650)721-4521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CYP2C19 Genetic Variants