RECRUITING

Metabolic and Epigenetic Impact of FAAH Inhibitors and OEA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-08-19
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07127445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ages 18-64 years old
  2. * BMI 25-30 inclusive (self-reported for screening, confirmed at first study visit)
  3. * For purposes of blood collection and other in-person procedures:
  4. * Willing and able to undergo three blood draws over 12 weeks
  5. * 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).
  6. * Willing and able to consume study product twice daily for about 12 weeks
  7. * Willing to track consumption of study product
  8. * Willing to keep diet, exercise, sleep habits, and current non-study supplement use the same throughout the study
  9. * Willing to limit alcohol consumption to "social drinking" (typically no more than 3 drinks per day and 7 per week) during the study
  10. * History of alcohol consumption limited to "social drinking" (typically no more than 3 drinks per day and 7 per week)
  11. * Willing to avoid recreational drugs and smoking/vaping for the duration of the study (approximately 12 weeks)
  12. * No metabolic disease (BMI\>30, diagnosis and treatment of hypertension, diabetes, or dyslipidemia)
  13. * No major diseases under treatment by doctor (Medical Reviewer's discretion)
  14. * No pregnancy within the last 60 days or currently breastfeeding (females)
  15. * No allergy to olive oil, lavender essential oil, ginger oleoresin/extract/essential oil, or OEA.
  16. * 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)
  17. * 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
  18. * No recreational drug or smoking/vaping use in the past 1 month
  19. * Not currently or previously participating in any other clinical trial within the last 30 calendar days
  1. * Failure to meet all inclusion criteria

Contacts and Locations

Study Contact

Nicole Stevens, PhD
CONTACT
801-615-7200
nstevens@doterra.com
Russell Osguthorpe Osguthorpe, MD
CONTACT
801-615-7200
rosguthorpe@doterra.com

Principal Investigator

Nicole Stevens, PhD
PRINCIPAL_INVESTIGATOR
doTERRA International

Study Locations (Sites)

doTERRA International
Pleasant Grove, Utah, 84062
United States

Collaborators and Investigators

Sponsor: Nicole Stevens, PhD

  • Nicole Stevens, PhD, PRINCIPAL_INVESTIGATOR, doTERRA International

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-19
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-08-19
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Gene expression
  • Dietary supplement
  • OEA
  • Lavender essential oil
  • Ginger

Additional Relevant MeSH Terms

  • Healthy