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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frankinscense | Experimental | 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. |
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| Lemon | Experimental | Lemon essential oil capsule (150mg per visit). Participants will consume two capsules: one capsule containing 150 mg of lemon oil and one capsule containing 150 mg of olive oil at each visit. |
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| Wild Orange | Experimental | Wild Orange essential oil capsule (150mg per visit). Participants will consume two capsules: one capsule containing 150 mg of wild orange oil and once capsule containing 150 mg of olive oil at each visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frankinscense Essential Oil Capsule | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Difference in C-max for each capsule type |
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Selection Criteria:
Participants must meet all the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gailen D Marshall Jr., MD, PhD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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| Lemon Essential Oil Capsule | Other | 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. |
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| Wild Orange Essential Oil Capsule | Other | 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. |
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Difference in the C-max levels compared between the types of capsule types based off analysis from primary outcomes.
| 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. | 24 hours |