HealthyNCT07581522

Pharmacokinetics of Essential Oils in Different Capsules

A study testing Frankinscense Essential Oil Capsule, Lemon Essential Oil Capsule and Wild Orange Essential Oil Capsule in people with Healthy and Health, Subjective, run by University of Mississippi Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Health, Subjective
What is being tested?: Frankinscense Essential Oil Capsule, Lemon Essential Oil Capsule and Wild Orange Essential Oil Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 2 Jul 2025to 19 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Mississippi Medical Center
Jackson, Mississippi, 39216

Other trials in United States

About this study

Official title: Pharmacokinetic Evaluation of Essential Oils in Different Capsule Matrices

Read the 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.

Conditions: Healthy, Health, Subjective
Being tested: Frankinscense Essential Oil Capsule, Lemon Essential Oil Capsule, Wild Orange Essential Oil Capsule
Keywords: Essential Oils, Frankincense, Lemon, Wild Orange

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Frankinscense Essential Oil CapsuleOther
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 CapsuleOther
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.
Wild Orange Essential Oil CapsuleOther
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.

Study groups in NCT07581522
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: Wild Orange Essential Oil Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 24 hours

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 202519 Dec 2025

First posted12 May 2026
Study start2 Jul 2025
Primary completion19 Dec 2025
Study completion19 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07581522
Sponsor's protocol ID: 2025-112
Status last verified: Apr 2026
First submitted: 23 May 2025
Last updated: 12 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Evaluation of Essential Oils in Different Capsule Matrices
ClinicalTrials.gov ID: NCT07581522
Acronym / sponsor ID: 2025-112
Conditions: Healthy, Health, Subjective
Keywords: Essential Oils, Frankincense, Lemon, Wild Orange
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of Mississippi Medical CenterUniversity, hospital or other
Study start: 2 Jul 2025 (actual)
Primary completion: 19 Dec 2025 (actual)
Study completion: 19 Dec 2025 (actual)
First posted: 12 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Frankinscense	Experimental	Other: Frankinscense Essential Oil CapsuleFrankincense 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.
Lemon	Experimental	Other: Lemon Essential Oil CapsuleLemon 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.
Wild Orange	Experimental	Other: Wild Orange Essential Oil CapsuleWild 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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Frankinscense Essential Oil CapsuleFrankincense 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.	Other	Frankinscense
Lemon Essential Oil CapsuleLemon 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.	Other	Lemon
Wild Orange Essential Oil CapsuleWild 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.	Other	Wild Orange

Primary outcome

Time to constituent concentration maximum in serum (T-max)
Time frame: 24 hours
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.
Maximum constituent concentration level (C-max)
Time frame: 24 hours
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 for the constituent concentration to decrease by half (T 1/2)
Time frame: 24 hours
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.

3 secondary outcomes

Difference in T-max for each capsule type
Time frame: 24 hours
Difference in C-max for each capsule type
Time frame: 24 hours
Difference in T 1/2 for each capsule type
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Individual participant dataSharing planned: No

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Enrolling by invitationObservational study
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Healthy Volunteer Samples
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gailen D Marshall Jr., MD, PhD principal investigator

University of Mississippi Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to constituent concentration maximum in serum (T-max) (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07581522.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.