Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06492694
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* Failure to meet any of the above inclusion criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT06492694
Study Brief:
Protocol Section:
NCT06492694