Pharmacokinetics of Essential Oils in Different Capsules
2026年5月5日 更新者：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).
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
19
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Mississippi
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Jackson、Mississippi、アメリカ、39216
- University of Mississippi Medical Center
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
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実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to constituent concentration maximum in serum (T-max)
時間枠：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.
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24 hours
|
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Maximum constituent concentration level (C-max)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in T-max for each capsule type
時間枠：24 hours
|
Difference in the T-max levels compared between the types of capsule types based off analysis from primary outcomes.
|
24 hours
|
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Difference in C-max for each capsule type
時間枠：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
時間枠：24 hours
|
Difference in the T-max levels compared between the types of capsule types based off analysis from primary outcomes.
|
24 hours
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Gailen D Marshall Jr., MD, PhD、University of Mississippi Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年7月2日
一次修了 (実際)
2025年12月19日
研究の完了 (実際)
2025年12月19日
試験登録日
最初に提出
2025年5月23日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月5日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2025-112
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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