Pharmacokinetics of Essential Oils in Different Capsules

NCT07581522 | Completed DMC

• 1 other identifier: 2025-112
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy; Health, Subjective

Keywords

Essential Oils; Frankincense; Lemon; Wild Orange

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Difference in T-max for each capsule type

  24 hours

• Difference in C-max for each capsule type

  24 hours

• Difference in T 1/2 for each capsule type

  24 hours

Study Arms (3)

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.

Other: Frankinscense Essential Oil Capsule

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.

Other: Lemon Essential Oil Capsule

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.

Other: Wild Orange Essential Oil Capsule

Interventions

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.

Frankinscense

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.

Lemon

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.

Wild Orange

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Study Officials

• Gailen D Marshall Jr., MD, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 12, 2026
• Study Start: July 2, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)