Pharmacokinetics of Essential Oils in Different Capsules
2026년 5월 5일 업데이트: 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).
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
19
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Mississippi
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Jackson, Mississippi, 미국, 39216
- University of Mississippi Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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실험적: 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.
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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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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to constituent concentration maximum in serum (T-max)
기간: 24 hours
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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.
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24 hours
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Maximum constituent concentration level (C-max)
기간: 24 hours
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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.
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24 hours
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Time for the constituent concentration to decrease by half (T 1/2)
기간: 24 hours
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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.
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24 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Difference in T-max for each capsule type
기간: 24 hours
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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
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Difference in C-max for each capsule type
기간: 24 hours
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Difference in the C-max levels compared between the types of capsule types based off analysis from primary outcomes.
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24 hours
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Difference in T 1/2 for each capsule type
기간: 24 hours
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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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Gailen D Marshall Jr., MD, PhD, University of Mississippi Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 7월 2일
기본 완료 (실제)
2025년 12월 19일
연구 완료 (실제)
2025년 12월 19일
연구 등록 날짜
최초 제출
2025년 5월 23일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2025-112
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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