Pharmacokinetics of Essential Oils in Different Capsules
5. maj 2026 opdateret af: University of Mississippi Medical Center
Pharmacokinetic Evaluation of Essential Oils in Different Capsule Matrices
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).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Frankinscense
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.
|
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.
|
|
Eksperimentel: Lemon
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.
|
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.
|
|
Eksperimentel: Wild Orange
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to constituent concentration maximum in serum (T-max)
Tidsramme: 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.
|
24 hours
|
|
Maximum constituent concentration level (C-max)
Tidsramme: 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.
|
24 hours
|
|
Time for the constituent concentration to decrease by half (T 1/2)
Tidsramme: 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.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in T-max for each capsule type
Tidsramme: 24 hours
|
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
Tidsramme: 24 hours
|
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
Tidsramme: 24 hours
|
Difference in the T-max levels compared between the types of capsule types based off analysis from primary outcomes.
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24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Gailen D Marshall Jr., MD, PhD, University of Mississippi Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. juli 2025
Primær færdiggørelse (Faktiske)
19. december 2025
Studieafslutning (Faktiske)
19. december 2025
Datoer for studieregistrering
Først indsendt
23. maj 2025
Først indsendt, der opfyldte QC-kriterier
5. maj 2026
Først opslået (Faktiske)
12. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2025-112
Plan for individuelle deltagerdata (IPD)
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