NCT07127445

Brief Summary

The goal of this clinical trial is to learn whether a dietary supplement can affect gene expression and serum protein markers in healthy volunteers. The main questions it aims to answer are:

  • Take one supplement capsule in the morning and one in the evening every day for 12 weeks
  • Attend three study visits in which they provide blood and urine samples, and undergo anthropometric measurements
  • Complete surveys and subjective health assessments

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

August 11, 2025

Last Update Submit

March 9, 2026

Conditions

Healthy

Keywords

Gene expressionDietary supplementOEALavender essential oilGinger

Outcome Measures

Primary Outcomes (2)

  • Gene expression

    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. The changes will be evaluated before and after treatment with the study supplement for 6 weeks.

    6 weeks

  • Hemoglobin A1C (HbA1c) (%)

    Change in blood HbA1c value before and after 12 weeks of treatment with the study supplement.

    12 weeks

Secondary Outcomes (15)

  • Comprehensive metabolic panel (CMP)

    12 weeks

  • Complete blood count (CBC)

    12 weeks

  • Generalized Anxiety Disorder-7 (GAD-7) scale

    12 weeks

  • Leptin (ng/mL)

    12 weeks

  • Apolipoprotein B (ApoB) (mg/dL)

    12 weeks

  • +10 more secondary outcomes

Study Arms (1)

Dietary supplement

EXPERIMENTAL

Participants take two capsules of the dietary supplement (one capsule in the morning and one in the evening) every day for 12 weeks.

Dietary Supplement: OEA supplement

Interventions

OEA supplementDIETARY_SUPPLEMENT

The supplement contains OEA, ginger extract, and lavender essential oil as its active ingredients.

Dietary supplement

Eligibility Criteria

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

You may qualify if:

  • Adults ages 18-64 years old
  • BMI 25-30 inclusive (self-reported for screening, confirmed at first study visit)
  • For purposes of blood collection and other in-person procedures:
  • o Reside within driving distance of the study center or be willing to travel to the study center
  • Willing and able to undergo three blood draws over 12 weeks
  • Willing to wash out of all internally-consumed 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 (14 weeks).
  • Willing and able to consume study product twice daily for about 12 weeks
  • Willing to track consumption of study product
  • Willing to keep diet, exercise, sleep habits, and current non-study supplement use the same throughout the study
  • Willing to limit alcohol consumption to "social drinking" (typically no more than 3 drinks per day and 7 per week) during the study
  • History of alcohol consumption limited to "social drinking" (typically no more than 3 drinks per day and 7 per week)
  • Willing to avoid recreational drugs and smoking/vaping for the duration of the study (approximately 12 weeks)
  • No metabolic disease (BMI\>30, diagnosis and treatment of hypertension, diabetes, or dyslipidemia)
  • No major diseases under treatment by doctor (Medical Reviewer's discretion)
  • No pregnancy within the last 60 days or currently breastfeeding (females)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

doTERRA International

Pleasant Grove, Utah, 84062, United States

Location

Study Officials

  • Nicole Stevens, PhD

    doTERRA International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice President, Clinical Research

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

August 19, 2025

Primary Completion

December 19, 2025

Study Completion

December 19, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)