Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Essential Oil-Based Product System for Digestive Support

15 juni 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Voedingssupplement: 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.
Ander: 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.
Placebo-vergelijker: 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.
Voedingssupplement: Placebo supplement
Placebo will be olive oil capsules of the same size and color as the active capsules.
Ander: placebo essential oil
Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
GSRS
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Albumine (g/dl)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Bloedureumstikstof (BUN) (mg/dl)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Alkalische fosfatase (U/L)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Alaninetransaminase (ALT) (U/L)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Aspartaataminotransferase (ASAT) (U/L)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Calcium (mg/dl)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Chloride (mmol/L)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Kalium (mmol/L)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Natrium (mmol/L)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Totaal bilirubine (mg/dl)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Totaal eiwit (g/dl)
Tijdsspanne: 4 weken
Item in uitgebreid metabolisch panel voor veiligheidsbeoordeling
4 weken
Gene expression
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks
Carbon dioxide (mmol/L)
Tijdsspanne: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

dōTERRA International

Onderzoekers

  • Hoofdonderzoeker: Nicole Stevens, doTERRA International LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

9 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juni 2026

Eerst geplaatst (Werkelijk)

17 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DO-126078-DZS

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren