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Essential Oil-Based Product System for Digestive Support

15 de junho de 2026 atualizado por: dōTERRA International

Efficacy and Safety of an Essential Oil-Based Product System for Digestive Support

This study aims to evaluate the efficacy of specific essential oils. Efficacy will be evaluated through changes, if any, to hsCRP, gene expression, and standard hematologic and metabolic parameters, as well as subjective health changes as measured by Gastrointestinal Symptom Rating Scale (GSRS), PROMIS Global Health survey, PROMIS Fatigue Scale, Immune Fitness Item Scale (IFIS), and the Immune Status Questionnaire (ISQ) in healthy volunteers. The main questions it aims to answer are:

  1. Do specific essential oils affect gene expression and hematologic and metabolic parameters as measured in blood?
  2. How do essential oils affect gut microbiome?
  3. How does daily use of specific essential oils affect subjective quality of life and health parameters?
  4. Is ingesting and topically applying specific essential oils daily safe, as measured by laboratory tests and adverse events?

Two study products will be used: oil for topical use, supplement for internal use. The two products will be used together and compared to a placebo group. The topical oil contains a blend of ginger essential oil, peppermint essential oil, caraway essential oil, coriander essential oil, and anise essential oil. The supplement contains everything the oil has, plus anise essential oil.

Participants will:

  • Be assigned one of the two groups.
  • Use the oil topically once each day for 4 weeks.
  • Take one supplement in the morning and one in the evening every day for 4 weeks.
  • Attend 2 study visits in which they provide blood and urine (females only) samples.
  • Complete 2 stool collection/microbiome kits
  • Complete surveys and subjective health assessments

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Digestive function plays a central role in daily comfort, quality of life, and overall well-being, even among generally healthy individuals. Many commercially available products are marketed to support normal digestive processes and gastrointestinal comfort; however, controlled human data evaluating their use under typical conditions in healthy populations remain limited. This study is designed to evaluate the tolerability, feasibility, and potential digestive-related effects of DigestZen when used as directed in a real-world context. DigestZen is a proprietary essential oil blend composed of Ginger, Peppermint, Caraway, Coriander, Anise, and Fennel essential oils, ingredients traditionally used to support digestive comfort and normal gastrointestinal function.

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

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.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Utah
      • Pleasant Grove, Utah, Estados Unidos, 84062
        • dōTERRA International
        • Contato:

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

Inclusion Criteria:

  • 18-45 years old
  • Willing to attend 2 study visits at Prime Meridian Health Clinic in Pleasant Grove, Utah
  • Willing and able to undergo 2 blood draws over 4 weeks
  • Willing to provide urine (females) and stool samples twice over 4 weeks
  • Willing to wash out of all internally and topically used essential oils or botanical products for at least 2 weeks prior to starting the study, and willing to maintain the washout for the duration of the study (4 weeks)
  • Willing and able to use study products as directed daily for about 4 weeks
  • Willing to avoid alcohol, recreational drugs, tobacco, and vaping for the duration of the study
  • Willing to track use of study products
  • Willing to maintain current sleep, diet, and exercise habits for the duration of the study
  • No major diseases under treatment by doctor (Medical Reviewer's discretion)
  • No pregnancy within the last 90 days or currently breastfeeding, or possibility of becoming pregnant.
  • No allergy to any of the ingredients in the study products
  • No regular consumption of the study products within the last 1 month
  • No alcohol, recreational drug, tobacco, or vaping use in the past 1 month
  • No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgement of the medical provider, put the participant at risk or affect study results, procedures, or outcomes.
  • Not currently or previously participating in another clinical trial within the last 30 calendar days.

Exclusion Criteria:

  • Failure to meet all listed inclusion criteria

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: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dietary supplement and topical oil
Participants take two capsules of the dietary supplement (one capsule in the morning and one in the evening) every day for 4 weeks. Participants will also place 2 mL of the oil on their forearms and stomach once daily at bedtime for 4 weeks.
Suplemento dietético: essential oil supplement
Internal use will entail ingesting Hypromellose capsules containing 135 mg essential oil and 365 mg extra virgin oil. The essential oils in the supplement are peppermint, coriander, ginger, caraway, cardamom, fennel, and anise. Participants will be instructed to take one capsule in the morning with food and one capsule in the evening with food, at least 3 hours before bedtime. Placebo will be olive oil capsules of the same size and color.
Outro: Essential Oil
Topical use will entail applying the DigestZen oil blend diluted to 10% in fractionated coconut oil using a metered dropper. Participants will be instructed to add 2mL to the skin of the inner forearms and belly area and massage until oil has absorbed. The application will happen once per day at bedtime. Placebo will contain fractionated coconut oil with a diluted single constituent for aroma and food coloring.
Comparador de Placebo: Placebo
Participants assigned the placebo study products will follow the same use directions as those in the active group. Placebo topical oil will contain fractionated coconut oil with a diluted single constituent for aroma and food coloring. The placebo supplement group will take a supplement that contains olive oil, and will be the same size and color as the active supplement.
Suplemento dietético: Placebo supplement
Placebo will be olive oil capsules of the same size and color as the active capsules.
Outro: placebo essential oil
Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
GSRS
Prazo: 4 weeks
Looking for within- and between treatment changes to Gastrointestinal Symptom Rating Scale (GSRS) from baseline to completion. The GSRS uses a 7-point Likert scale for the 15 questions regarding gastrointestinal symptoms with answers ranging from "No discomfort at all" to "Very severe discomfort." Scores range from 15 to 105, and the total score is the sum of all item scores. Higher scores indicate more severe GI symptoms.
4 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Albumina (g/dL)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Nitrogênio ureico no sangue (BUN) (mg/dL)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Fosfatase alcalina (U/L)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Alanina transaminase (ALT) (U/L)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Aspartato aminotransferase (AST) (U/L)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Cálcio (mg/dL)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Cloreto (mmol/L)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Potássio (mmol/L)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Sódio (mmol/L)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Bilirrubina total (mg/dL)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Proteína total (g/dL)
Prazo: 4 semanas
Item no painel metabólico abrangente para avaliação de segurança
4 semanas
Gene expression
Prazo: 4 weeks
Gene expression analysis refers to a genome-wide quantification of methylation. EPIC850K array will be used for methylation analysis. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another.
4 weeks
Complete blood count (CBC)
Prazo: 4 weeks
Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count.
4 weeks
Gut microbiome test
Prazo: 4 weeks
Participants complete stool collection kits. Stool is analyzed for gut microbiome composition (e.g. bacteria %/count/type)
4 weeks
Digestion-associated Quality of Life Questionnaire (DQLQ)
Prazo: 4 weeks
Validated, self-reported scale for the measurement of digestion-associated quality of life outcomes. The DQLQ is a 9-item scale with total scores between 0 and 9. Each item is scored as a percentage 0-100, with 100 representing a score of 1. Higher scores indicate greater dissatisfaction with digestion-associated quality of life outcomes.
4 weeks
PROMIS Global Health survey
Prazo: 4 weeks
Validated, self-reported scale that assesses overall health-related quality of life across physical, mental, and social domains. The PROMIS Global Health Survey (v1.2) is a 10-item scale, with items scored between 1 and 5 each. Higher scores are indicative of a healthier person, with exceptions to the questions related to fatigue where a higher score indicates greater fatigue.
4 weeks
Adverse events
Prazo: 4 weeks
This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology/pregnancy testing (females).
4 weeks
Creatinine (mg/dL)
Prazo: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks
Carbon dioxide (mmol/L)
Prazo: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

dōTERRA International

Investigadores

  • Investigador principal: Nicole Stevens, doTERRA International LLC

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 (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

9 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DO-126078-DZS

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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