Essential Oil-Based Product System for Digestive Support

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:

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

Conditions

• Healthy

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

DIETARY_SUPPLEMENT

Placebo supplement

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

OTHER

placebo essential oil

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

Sponsors & Collaborators

• dōTERRA International

  lead INDUSTRY

Principal Investigators

• Nicole Stevens · doTERRA International LLC

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-11-30

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations