Status:
COMPLETED
Omega-3 Supplement and Health Markers
Lead Sponsor:
dōTERRA International
Conditions:
Healthy
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn whether fish oil-based supplements can affect gene expression and serum protein markers in healthy volunteers. The main questions it aims to answer are: 1....
Detailed Description
This randomized, double-blind study will recruit healthy adults to compare gene expression profile, omega-3 levels, and protein markers before and after consumption of fish oil supplements for approxi...
Eligibility Criteria
Inclusion
- Males and females, 18-64 years old
- Local to Pleasant Grove, Utah, and/or willing to come to the clinical research center for study visits
- Willing to provide blood and urine samples during study visits
- Willing and able to consume study product daily for about 6 weeks
- Willing to track consumption of study product
- Willing to keep diet, exercise, sleeping, and current non-study supplement use the same throughout the study
- Willing to avoid alcohol, recreational drugs, and smoking/vaping for the duration of the study (approximately 7 weeks)
- Willing to wash out of all internally-consumed essential oil and botanical products for at least 2 weeks prior to starting the study and willing to maintain the washout for the duration of the study (about 9 weeks)
- Willing to receive and respond to regular texts, emails, and/or phone calls from study staff
- No metabolic disease (BMI\>35, diagnosis and treatment of hypertension, diabetes, or dyslipidemia)
- No major diseases under treatment by a doctor (Medical Reviewer's discretion)
- No pregnancy within the last 60 days or currently breastfeeding (females)
- No allergy to fish oil, olive oil, or orange essential oil
- No regular internal consumption of orange essential oil 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 regular internal consumption of omega-3 or other fish oil supplements 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 alcohol, recreational drug, or smoking/vaping use in the past 1 month
- 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
- Not currently or previously participating in any other clinical trial within the last 30 calendar days
- Signed informed consent, HIPAA Authorization, and Confidentiality Agreement
Exclusion
- Failure to meet any of the above inclusion criteria
Key Trial Info
Start Date :
June 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06492694
Start Date
June 10 2024
End Date
September 3 2024
Last Update
January 8 2025
Active Locations (1)
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1
doTERRA International
Pleasant Grove, Utah, United States, 84062