This open label study will recruit healthy adults to investigate the pharmacokinetics of oral ingestion of frankincense, lemon, and wild orange essential oils. This study will also evaluate whether the delivery matrix (capsule type) affects the pharmacokinetics of the oils. Secondary outcomes include safety markers (liver and kidney function, hematology, urinalysis, and adverse events).
This open label study will recruit healthy adults to investigate the pharmacokinetics of oral ingestion of frankincense, lemon, and wild orange essential oils. This study will also evaluate whether the delivery matrix (capsule type) affects the pharmacokinetics of the oils. Secondary outcomes include safety markers (liver and kidney function, hematology, urinalysis, and adverse events). Samples will be collected at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours after ingestion of assigned essential oil. Blood and urine markers will be assessed to determine the pharmacokinetics of each essential oil and how the capsule matrix effects these. Pharmacokinetic parameters will be measured in serum. Chromatography and mass spectrometry will be used to detect and measure the essential oil constituents of interest in serum. Each arm of the study includes a pharmacokinetic analysis, and arms will be compared to one another. T-max (time to constituent concentration maximum in serum), C-max (maximum constituent concentration level), and T1/2 (time for the constituent concentration to decrease by half) will serve as the primary outcome measurements. Pharmacokinetics analysis software will be used to generate pharmacokinetic data from the chromatography and mass spectrometry results.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
19
Frankincense essential oil capsule (150mg per visit). Participants will consume one capsule containing 150 mg of frankincense oil and 150 mg of olive oil at each visit. At the first visit, participants will receive the essential oil in a delayed-release hypromellose (HPMC capsule), followed by a HPMC Capsule at the second visit, and a Tapioca softgel capsule at the third visit.
Lemon essential oil capsule (150mg per visit). Participants will consume one capsule containing 150 mg of frankincense oil and one capsule containing 150 mg of olive oil at each visit. At the first visit, participants will receive the essential oil in a delayed-release hypromellose (HPMC capsule), followed by a HPMC Capsule at the second visit, and a Tapioca softgel capsule at the third visit.
University of Mississippi Medical Center
Jackson, Mississippi, United States
Time to constituent concentration maximum in serum (T-max)
Amount of time it takes for each essential oil to reach the maximum concentration in serum compared to baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, and 24 hours.
Time frame: 24 hours
Maximum constituent concentration level (C-max)
Maximum amount of each essential oil concentration measured in the blood. Timepoints will be measured at baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, and 24 hours.
Time frame: 24 hours
Time for the constituent concentration to decrease by half (T 1/2)
Amount of time it takes for each essential oil level to decrease by half as measured at baseline, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, and 24 hours.
Time frame: 24 hours
Difference in T-max for each capsule type
Difference in the T-max levels compared between the types of capsule types based off analysis from primary outcomes.
Time frame: 24 hours
Difference in C-max for each capsule type
Difference in the C-max levels compared between the types of capsule types based off analysis from primary outcomes.
Time frame: 24 hours
Difference in T 1/2 for each capsule type
Difference in the T-max levels compared between the types of capsule types based off analysis from primary outcomes.
Time frame: 24 hours
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Wild Orange essential oil capsule (150mg per visit). Participants will consume one capsule containing 150 mg of frankincense oil and once capsule containing 150 mg of olive oil at each visit. At the first visit, participants will receive the essential oil in a delayed-release hypromellose (HPMC capsule), followed by a HPMC Capsule at the second visit, and a Tapioca softgel capsule at the third visit.