NCT07653815

Brief Summary

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:

  • 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
1mo left

Started Nov 2026

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

March 9, 2026

Last Update Submit

June 15, 2026

Conditions

Healthy

Keywords

gene expressionessential oilsgut microbiome

Outcome Measures

Primary Outcomes (1)

  • GSRS

    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

Secondary Outcomes (19)

  • Gene expression

    4 weeks

  • Complete blood count (CBC)

    4 weeks

  • Gut microbiome test

    4 weeks

  • Digestion-associated Quality of Life Questionnaire (DQLQ)

    4 weeks

  • PROMIS Global Health survey

    4 weeks

  • +14 more secondary outcomes

Study Arms (2)

Dietary supplement and topical oil

EXPERIMENTAL

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.

Dietary Supplement: essential oil supplementOther: Essential Oil

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo supplementOther: placebo essential oil

Interventions

essential oil supplementDIETARY_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.

Dietary supplement and topical oil
Essential OilOTHER

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.

Dietary supplement and topical oil
Placebo supplementDIETARY_SUPPLEMENT

Placebo will be olive oil capsules of the same size and color as the active capsules.

Placebo
placebo essential oilOTHER

Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

doTERRA International

Pleasant Grove, Utah, 84062, United States

Location

MeSH Terms

Interventions

Oils, Volatile

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Nicole Stevens

    doTERRA International LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Stevens

CONTACT

8016157200nstevens@doterra.com

Russell Osguthorpe

CONTACT

8016157200rosguthorpe@doterra.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

June 17, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)