NCT07127445

Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Nicole Stevens, PhD · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2025-08-19
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2025-08-17
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States