HealthyNCT07127445
Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA
A study testing OEA supplement in people with Healthy, run by Nicole Stevens, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OEA supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Show all 20Show fewer
- 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
Who cannot join
- Failure to meet all inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic and Epigenetic Impact of Concomitant Fatty Acid Amide Hydrolase Inhibitors and Oleoylethanolamide in a Novel Delivery
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:
- Does the supplement affect gene expression and protein markers as measured in blood?
- How does daily ingestion of the supplement affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?
- How does daily ingestion of the supplement affect subjective health parameters?
- Is ingesting the supplement daily safe, as measured by laboratory tests and adverse events?
Read more
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
Read the 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
- Being tested
- OEA supplement
- Keywords
- Gene expression, Dietary supplement, OEA, Lavender essential oil, Ginger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OEA supplementDietary supplement
The supplement contains OEA, ginger extract, and lavender essential oil as its active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: OEA supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Hemoglobin A1C (HbA1c) (%)
Change in blood HbA1c value before and after 12 weeks of treatment with the study supplement.
Measured: 12 weeks
Secondary outcomes (15)
Comprehensive metabolic panel (CMP)
Panel used in safety assessment. Change in blood comprehensive metabolic panel values before and after 12 weeks of treatment with the study supplement, including:
Albumin (g/dL) Blood urea nitrogen (BUN) (mg/dL) Creatinine (mg/dL) Alkaline phosphatase (U/L) Alanine transaminase (ALT) (U/L) Aspartate aminotransferase (AST) (U/L) Calcium (mg/dL) Carbon Dioxide (mmol/L) Chloride (mmol/L) Potassium (mmol/L) Sodium (mmol/L) Total bilirubin (mg/dL) Total protein (g/dL)
Measured: 12 weeks
Complete blood count (CBC)
Panel used in safety assessment. Change in complete blood count values before and after 12 weeks of treatment with the study supplement, including:
White blood cells (x10E3/uL) Red blood cells (x10E6/uL) Hemoglobin (g/dL) Hematocrit (%) Mean corpuscular volume (fL) Mean corpuscular hemoglobin (pg) Mean corpuscular hemoglobin concentration (g/dL) Red cell distribution width (%) Platelets (x10E3/uL) Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Basophils (%) Neutrophils (Absolute) (x10E3/uL) Lymphocytes (Absolute) (x10E3/uL) Monocytes (Absolute) (x10E3/uL) Basophils (Absolute) (x10E3/uL) Immature granulocytes (%) Immature granulocytes (Absolute) (x10E3/uL)
Measured: 12 weeks
Generalized Anxiety Disorder-7 (GAD-7) scale
Validated, self-reported scale for the measurement of anxiety severity. The GAD-7 is a 7-item scale with total scores between 0 and 21. Higher scores indicate higher anxiety severity.
Measured: 12 weeks
Leptin (ng/mL)
Change in blood leptin value before and after 12 weeks of treatment with the study supplement.
Measured: 12 weeks
Apolipoprotein B (ApoB) (mg/dL)
Change in blood ApoB value before and after 12 weeks of treatment with the study supplement.
Measured: 12 weeks
High sensitivity C-reactive protein (mg/dL)
Change in hsCRP (serum marker for inflammation and cardiac health) before and after treatment with the study supplement.
Measured: 12 weeks
Patient Health Questionnaire (PHQ-8) scale
Validated, self-reported scale for the measurement of depression severity. The PHQ-8 is an 8-item scale with total scores between 0 and 12. Higher scores indicate higher depression severity.
Measured: 12 weeks
Leeds Sleep Evaluation Questionnaire (LSEQ) scale
Validated, self-reported scale for the measurement of sleep quality. The LSEQ is a 10-item scale. Each item is scored 0 to 100. Higher scores indicate better sleep quality.
Measured: 12 weeks
Body weight (kg)
Determine whether body weight (including body composition %) is affected by the consumption of the study product.
Measured: 12 weeks
Lipid panel
Change in blood lipid panel values before and after 12 weeks of treatment with the study supplement, including:
Total cholesterol (mg/dL) Triglycerides (mg/dL) High density lipoprotein (HDL) Cholesterol (mg/dL) Very Low density lipoprotein (VLDL) Cholesterol (mg/dL) Low density lipoprotein (LDL) Cholesterol (mg/dL)
Measured: 12 weeks
Blood pressure (mmHg)
Determine whether blood pressure is affected by the consumption of the study product.
Measured: 12 weeks
Heart rate (BPM)
Determine whether heart rate is affected by the consumption of the study product.
Measured: 12 weeks
Waist circumference (cm)
Determine whether waist circumference is affected by the consumption of the study product.
Measured: 12 weeks
Safety/tolerability
This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses.
Measured: 12 weeks
Erythrocyte Sedimentation Rate (ESR) (mm/h)
Change in ESR (blood marker for inflammation) before and after treatment with the study supplement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start19 Aug 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicole Stevens, PhD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Nicole Stevens, PhD, dōTERRA International
- Investigators
- Nicole Stevens, PhD, Principal investigator, doTERRA International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127445
- Sponsor's protocol ID
- DO-124043-OEA
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Epigenetic Impact of Concomitant Fatty Acid Amide Hydrolase Inhibitors and Oleoylethanolamide in a Novel Delivery
- ClinicalTrials.gov ID
- NCT07127445
- Acronym / sponsor ID
- DO-124043-OEA
- Conditions
- Healthy
- Keywords
- Gene expression, Dietary supplement, OEA, Lavender essential oil, Ginger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Nicole Stevens, PhDIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the supplement affect gene expression and protein markers as measured in blood?
- How does daily ingestion of the supplement affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?
- How does daily ingestion of the supplement affect subjective health parameters?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Experimental | Dietary Supplement: OEA supplementParticipants take two capsules of the dietary supplement (one capsule in the morning and one in the evening) every day for 12 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OEA supplementThe supplement contains OEA, ginger extract, and lavender essential oil as its active ingredients. | Dietary supplement | Dietary supplement |
Primary outcome
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.
15 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Stevens, PhD principal investigator
doTERRA International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OEA supplement in people with Healthy, run by Nicole Stevens, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.