---
title: Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA
nct_id: NCT07127445
overall_status: COMPLETED
phase: NA
sponsor: Nicole Stevens, PhD
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07127445.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07127445"
ct_last_update_post_date: 2026-03-10
last_seen_at: "2026-05-12T07:12:30.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA

**Official Title:** Metabolic and Epigenetic Impact of Concomitant Fatty Acid Amide Hydrolase Inhibitors and Oleoylethanolamide in a Novel Delivery

**NCT ID:** [NCT07127445](https://clinicaltrials.gov/study/NCT07127445)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 92
- **Lead Sponsor:** Nicole Stevens, PhD
- **Conditions:** Healthy
- **Start Date:** 2025-08-19
- **Completion Date:** 2025-12-19
- **CT.gov Last Update:** 2026-03-10

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 64 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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

Exclusion Criteria:

* Failure to meet all inclusion criteria
```

## Arms

- **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.

## Interventions

- **OEA supplement** (DIETARY_SUPPLEMENT) — The supplement contains OEA, ginger extract, and lavender essential oil as its active ingredients.

## Primary Outcomes

- **Gene expression** _(time frame: 6 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. The changes will be evaluated before and after treatment with the study supplement for 6 weeks.
- **Hemoglobin A1C (HbA1c) (%)** _(time frame: 12 weeks)_ — Change in blood HbA1c value before and after 12 weeks of treatment with the study supplement.

## Secondary Outcomes

- **Comprehensive metabolic panel (CMP)** _(time frame: 12 weeks)_
- **Complete blood count (CBC)** _(time frame: 12 weeks)_
- **Generalized Anxiety Disorder-7 (GAD-7) scale** _(time frame: 12 weeks)_
- **Leptin (ng/mL)** _(time frame: 12 weeks)_
- **Apolipoprotein B (ApoB) (mg/dL)** _(time frame: 12 weeks)_
- **High sensitivity C-reactive protein (mg/dL)** _(time frame: 12 weeks)_
- **Patient Health Questionnaire (PHQ-8) scale** _(time frame: 12 weeks)_
- **Leeds Sleep Evaluation Questionnaire (LSEQ) scale** _(time frame: 12 weeks)_
- **Body weight (kg)** _(time frame: 12 weeks)_
- **Lipid panel** _(time frame: 12 weeks)_
- **Blood pressure (mmHg)** _(time frame: 12 weeks)_
- **Heart rate (BPM)** _(time frame: 12 weeks)_
- **Waist circumference (cm)** _(time frame: 12 weeks)_
- **Safety/tolerability** _(time frame: 12 weeks)_
- **Erythrocyte Sedimentation Rate (ESR) (mm/h)** _(time frame: 12 weeks)_

## Locations (1)

- doTERRA International, Pleasant Grove, Utah, United States

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.doterra international|pleasant grove|utah|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07127445.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07127445*  
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