Pharmacokinetics of Essential Oils in Different Capsules
5 de maio de 2026 atualizado por: 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).
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
19
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216
- University of Mississippi Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to constituent concentration maximum in serum (T-max)
Prazo: 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)
Prazo: 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.
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24 hours
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Time for the constituent concentration to decrease by half (T 1/2)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Difference in T-max for each capsule type
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Gailen D Marshall Jr., MD, PhD, University of Mississippi Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de julho de 2025
Conclusão Primária (Real)
19 de dezembro de 2025
Conclusão do estudo (Real)
19 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
23 de maio de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
12 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2025-112
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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