Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA

NCT ID: NCT07127445

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-19
• Study Completion Date: 2025-12-31

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:

1. Does the supplement affect gene expression and protein markers as measured in blood?

2. How does daily ingestion of the supplement affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?

3. How does daily ingestion of the supplement affect subjective health parameters?

4. Is ingesting the supplement daily safe, as measured by laboratory tests and adverse events?

The supplement is made with oleoylethanolamide (OEA), ginger extract, and lavender essential oil.

Participants will:

• 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

Detailed Description

This open-label, repeated measures study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of a dietary supplement for 12 weeks. Secondary outcomes include anthropometric measurements, vitals, and other subjective health assessments. Safety data (from blood sampling, urinalysis, and adverse events) will be collected.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dietary supplement

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

Group Type: EXPERIMENTAL

OEA supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

OEA supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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)
• No allergy to olive oil, lavender essential oil, ginger oleoresin/extract/essential oil, or OEA.
• No regular internal consumption of lavender essential oil, ginger oleoresin or extract, or OEA within the last 1 month (regularly is defined as dosing daily for more than 2 consecutive weeks, or dosing more than 2-3 times per week for 4 consecutive weeks)
• No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk or affect study results, procedures, or outcomes
• No recreational drug or smoking/vaping use in the past 1 month
• Not currently or previously participating in any other clinical trial within the last 30 calendar days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nicole Stevens, PhD

INDUSTRY

Sponsor Role: lead

Responsible Party

Nicole Stevens, PhD

Vice President, Clinical Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicole Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

doTERRA International

Locations

doTERRA International

Pleasant Grove, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Stevens, PhD

Role: CONTACT

nstevens@doterra.com

801-615-7200

Russell Osguthorpe Osguthorpe, MD

Role: CONTACT

rosguthorpe@doterra.com

801-615-7200

Facility Contacts

Nicole Stevens, PhD

Role: primary

nstevens@doterra.com

801-615-7200

Other Identifiers

DO-124043-OEA

Identifier Type: -

Identifier Source: org_study_id