Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Essential Oil-Based Product System for Digestive Support

15. juni 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: 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.
Andet: 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 komparator: 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.
Kosttilskud: Placebo supplement
Placebo will be olive oil capsules of the same size and color as the active capsules.
Andet: placebo essential oil
Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
GSRS
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Albumin (g/dL)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Urinstofnitrogen i blodet (BUN) (mg/dL)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Alkalisk fosfatase (U/L)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Alanintransaminase (ALT) (U/L)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Aspartataminotransferase (AST) (U/L)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Calcium (mg/dL)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Klorid (mmol/L)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Kalium (mmol/L)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Natrium (mmol/L)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Total bilirubin (mg/dL)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Samlet protein (g/dL)
Tidsramme: 4 uger
Punkt i omfattende metabolisk panel til sikkerhedsvurdering
4 uger
Gene expression
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks
Carbon dioxide (mmol/L)
Tidsramme: 4 weeks
Item in comprehensive metabolic panel for safety assessment
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

dōTERRA International

Efterforskere

  • Ledende efterforsker: Nicole Stevens, doTERRA International LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

9. marts 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DO-126078-DZS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med essential oil supplement

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner