CYP2C19 Variants and Limonene Metabolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Limonene.
- Who it may be relevant to
- Registry conditions: CYP2C19 Genetic Variants. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Functional Consequences of CYP2C19 Variants on Limonene Metabolism in Humans
Overview
The investigators will examine whether a non-invasive screening tool for CYP2C19 genetic variants can be developed by measuring limonene metabolism.
Detailed description
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.
Interventions
- Dietary supplement 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 measures
- Breath limonene value in parts per billion [Time frame: 2 hours]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Stanford School of Medicine — Stanford
Identifiers
NCT: NCT05078723 · 59978