OEA Supplement for Healthy Volunteers

Overseen By Russell Osguthorpe Osguthorpe, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nicole Stevens, PhD

Disqualifiers: Metabolic disease, Major diseases, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a dietary supplement affects genes and blood proteins in healthy individuals. The supplement contains oleoylethanolamide (OEA, a natural compound), ginger, and lavender. Researchers seek to understand if daily intake of this supplement for 12 weeks influences weight, waist size, blood pressure, heart rate, and overall health perceptions. Healthy adults with a BMI of 25-30, without major illnesses, and able to travel to the study site may be suitable candidates. Participants will take the supplement twice daily, have blood drawn, and complete health surveys. As an unphased trial, this study provides a unique opportunity to contribute to understanding the health benefits of natural supplements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop using any essential oils or botanical products internally for at least 2 weeks before starting and during the study.

What prior data suggests that this supplement is safe for healthy volunteers?

Research has shown that oleoylethanolamide (OEA) is generally safe at certain doses. In some studies, the highest dose tested without negative effects was 2500 mg per kilogram of body weight per day. Other smaller studies used doses of 250 mg per day of OEA without major safety concerns. Common side effects of OEA include difficulty sleeping, weight loss, and headaches.

For ginger extract and lavender essential oil, which are also in the supplement, specific safety data from these studies is not available. However, both are often used in foods and other products without problems.

Overall, the supplement appears well-tolerated when used in reasonable amounts, but monitoring for any side effects during use is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which often involves lifestyle changes and medications for managing weight, OEA (oleoylethanolamide) is a naturally occurring lipid that acts differently. It is known for its role in regulating hunger and metabolism by signaling the brain to enhance feelings of fullness. Researchers are excited because OEA has the potential to offer a more natural way to support healthy weight management without the side effects typically associated with pharmaceutical options. This supplement could also be taken conveniently as capsules, making it accessible and easy to incorporate into daily routines.

What evidence suggests that this supplement could be effective for healthy volunteers?

Research shows that oleoylethanolamide (OEA), the main ingredient in the supplement tested in this trial, may aid in weight loss and reduce waist size. Studies have found that OEA can lower fasting blood sugar and insulin levels, which is important for managing weight and overall health. Additionally, OEA might improve fat processing and reduce inflammation, offering various health benefits. Early research suggests that OEA helps protect cells from damage by reducing oxidative stress. These findings indicate that the supplement might positively affect metabolism and weight management in healthy individuals. ^{3 6 7 8 9}

Who Is on the Research Team?

Nicole Stevens, PhD

Principal Investigator

doTERRA International

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in participating in a study to evaluate the effects of a dietary supplement on gene expression and health markers. Participants will take two capsules daily, attend three study visits, and complete health assessments over 12 weeks.

Inclusion Criteria

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 allergy to olive oil, lavender essential oil, ginger oleoresin/extract/essential oil, or OEA

Exclusion Criteria

Failure to meet all inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take one supplement capsule in the morning and one in the evening every day for 12 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OEA

Trial Overview The trial tests if oleoylethanolamide (OEA) combined with ginger extract and lavender oil can impact gene expression, protein markers, body measurements like BMI and waist size, blood pressure, heart rate, and subjective health feelings.

How Is the Trial Designed?

Group I: Dietary supplement Experimental Treatment 1 Intervention

Participants take two capsules of the dietary supplement (one capsule in the morning and one in the evening) every day for 12 weeks.

Who Is Running the Clinical Trial?

Nicole Stevens, PhD

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12259213/

The effect of oleoylethanolamide supplementation on ... Data from 13 studies indicated substantial reductions in fasting blood sugar (WMD: −5.84 mg/dl), insulin (WMD: −3.26 µU/ml), waist circumference ...

2. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1553288/full

Oleoylethanolamide supplementation on cardiometabolic ... Supplementation with OEA may help improve glycemic control, weight loss, waist circumference, fat mass, fat percentage, inflammation, and oxidative stress.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332225003956

Anti-obesity effects of Oleoylethanolamide OEA improved liver mitochondrial oxidative capacity, lipid metabolism and oxidative stress. It reduced intestinal levels of the endocannabinoid 2- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6156479/

Oleoylethanolamide Supplementation Reduces Inflammation ... In summary, daily supplementation of two 125 mg oleoylethanolamide in 56 healthy obese people for 8 weeks significantly decreased the levels of IL-6 and TNF ...

5. journals.lww.com journals.lww.com/cardiovascularendocrinology/_layouts/15/oaks.journals/downloadpdf.aspx?an=02045117-202509000-00003

The effect of oleoylethanolamide supplementation on ... (3) Outcomes: The study outcomes encompassed var- ious factors, including glucose metabolism [fast- ing blood sugar (FBS) and insulin], ...

6. echemi.com echemi.com/sds/n-oleoylethanolamine-pid_Seven1172.html

Oleoylethanolamide SDS, 111-58-0 Safety Data Sheets Skin irritation, Category 2. Serious eye damage, Category 1. Hazardous to the aquatic environment, long-term (Chronic) - Category Chronic 2 ...

7. scivisionpub.com scivisionpub.com/pdfs/a-comprehensive-safety-profile-of-oleoylethanolamide-3241.pdf

A Comprehensive Safety Profile of Oleoylethanolamide The No Observed Adverse Effect Level (NOAEL) of oleoylethanolamide is found to be 2500 mg/kg b.wt./day body weight under tested conditions.

8. researchgate.net researchgate.net/publication/381622132_A_Comprehensive_Safety_Profile_of_Oleoylethanolamide

A Comprehensive Safety Profile of Oleoylethanolamide developed, however, without adequate safety data. In a very limited number of previous clinical trials, doses of. 250 mg/d of OEA oral intake ...

9. nature.com nature.com/articles/s41386-020-0686-z

a novel potential treatment for binge eating disorder Its most common side effects include insomnia, weight loss, and headache [14], and its highest limit derives from serious adverse effects in ...