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Essential Oil-Based Product System for Digestive Support

15 de junio de 2026 actualizado 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otro: 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 placebos: 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.
Otro: placebo essential oil
Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
GSRS
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Albúmina (g/dL)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Nitrógeno ureico en sangre (BUN) (mg/dL)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Fosfatasa alcalina (U/L)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Alanina transaminasa (ALT) (U/L)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Aspartato aminotransferasa (AST) (U/L)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Calcio (mg/dL)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Cloruro (mmol/L)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Potasio (mmol/L)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Sodio (mmol/L)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Bilirrubina total (mg/dL)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Proteínas totales (g/dL)
Periodo de tiempo: 4 semanas
Artículo en panel metabólico integral para evaluación de seguridad
4 semanas
Gene expression
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks
Carbon dioxide (mmol/L)
Periodo de tiempo: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

dōTERRA International

Investigadores

  • Investigador principal: Nicole Stevens, doTERRA International LLC

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

9 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • DO-126078-DZS

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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