Status:

COMPLETED

Frankincense Supplements and Inflammation

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 frankincense essential oil-based supplements can affect gene expression and serum protein markers in healthy volunteers. The main questions it aims ...

Detailed Description

This randomized, double-blind study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of frankincense essential oil supplemen...

Eligibility Criteria

Inclusion

  • Males and females, 18-64 years old
  • 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 7 weeks)
  • 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 4 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 5 weeks)
  • Willing to wash out of internally-consumed essential oil and botanical products for approximately 7 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 doctor (Medical Reviewer's discretion)
  • No pregnancy within the last 60 days or currently breastfeeding (females)
  • No allergy to olive oil, frankincense essential oil, or boswellic acid
  • No internal consumption of frankincense oil regularly 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 17 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 21 2024

Estimated Enrollment :

67 Patients enrolled

Trial Details

Trial ID

NCT06488417

Start Date

June 17 2024

End Date

August 21 2024

Last Update

August 22 2024

Active Locations (1)

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1

doTERRA International

Pleasant Grove, Utah, United States, 84062

Frankincense Supplements and Inflammation | DecenTrialz