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Pharmacokinetics of Essential Oils in Different Capsules

Pharmacokinetic Evaluation of Essential Oils in Different Capsule Matrices

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07581522
Enrollment
19
Registered
2026-05-12
Start date
2025-07-02
Completion date
2025-12-19
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Subjective, Healthy

Keywords

Essential Oils, Frankincense, Lemon, Wild Orange

Brief summary

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).

Detailed description

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.

Interventions

OTHERFrankinscense Essential Oil Capsule

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.

OTHERLemon Essential Oil Capsule

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.

OTHERWild Orange Essential Oil Capsule

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.

Sponsors

University of Mississippi Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

Selection Criteria: Participants must meet all the following criteria: * Adults ages 18-35 years old * Local to metropolitan Jackson, MS, and/or willing to come to the clinical research center for study visits * Willing to wash out of all internally consumed essential oil and botanical products for at least 2 weeks prior to starting the study and willing to maintain the washout for the duration of the study (approximately 8 weeks) * Willing to avoid all frankincense, wild orange, and lemon essential oil in any form (aromatic, topical, or internal) for the duration of the study (approximately 5 weeks). * Willing to avoid alcohol, recreational drugs, and smoking/vaping for 3 days prior to each arm of the study * Willing to receive an intravenous catheter in the arm or hand every two weeks for 4 weeks (three times total) * History of successful blood/plasma donation, IV insertion, or blood collection by phlebotomy * Weigh at least 110 pounds * No uncontrolled metabolic disease * No unstable major diseases under treatment by healthcare professional * No pregnancy within the last 60 days or currently breastfeeding (females) * No allergy to olive oil or frankincense, lemon, or wild orange essential oils * No regular internal consumption of frankincense, lemon, or wild orange essential oil regularly within the last 1 month (regularly is defined as dosing daily for more than 2 consecutive weeks, or dosing more than 2-3 times per week for 4 consecutive weeks) * No alcohol, recreational drug, or smoking/vaping use in the past 3 days * No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk or affect study results, procedures, or outcomes * Not currently or previously participating in any other clinical trial within the last 30 calendar days

Design outcomes

Primary

MeasureTime frameDescription
Time to constituent concentration maximum in serum (T-max)24 hoursAmount 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.
Maximum constituent concentration level (C-max)24 hoursMaximum 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 for the constituent concentration to decrease by half (T 1/2)24 hoursAmount 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.

Secondary

MeasureTime frameDescription
Difference in T-max for each capsule type24 hoursDifference in the T-max levels compared between the types of capsule types based off analysis from primary outcomes.
Difference in C-max for each capsule type24 hoursDifference in the C-max levels compared between the types of capsule types based off analysis from primary outcomes.
Difference in T 1/2 for each capsule type24 hoursDifference in the T-max levels compared between the types of capsule types based off analysis from primary outcomes.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGailen D Marshall Jr., MD, PhD

University of Mississippi Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026