Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA

Nicole Stevens, PhD

Status

Enrolling

Conditions

Healthy

Treatments

Dietary Supplement: OEA supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT07127445

DO-124043-OEA

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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