Frankincense Supplements and Inflammation

dōTERRA

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Frankincense essential oil supplement; Dietary Supplement: Frankincense essential oil + boswellic acid supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06488417

DO-124033-FRA

Details and patient eligibility

About

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 to answer are:

1. Do frankincense essential oil supplements affect gene expression and protein markers as measured in blood?
2. How does daily ingestion of frankincense supplements affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?
3. How does daily ingestion of frankincense essential oil supplements affect subjective quality of life and health parameters?
4. Is ingesting frankincense essential oil supplements daily safe, as measured by laboratory tests and adverse events?

Researchers will compare two types of frankincense essential oil supplements. One type contains frankincense essential oil and boswellic acid as its active ingredients. The other type contains only frankincense essential oil as its active ingredient.

Participants will:

• Be assigned one of the two types of frankincense essential oil supplement
• Take two capsules of their assigned supplement every day for about 30 days
• Attend two study visits in which they provide blood and urine samples, complete subjective health and quality of life assessments, and undergo anthropometric measurements
• Complete weekly subjective health assessments from home

Full 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 supplements for approximately 4 weeks. Quality of life will also be assessed using subjective surveys and questionnaires. Safety markers (liver and kidney function, hematology, urinalysis, and adverse events) will be collected.

Enrollment: 67 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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 criteria

• Failure to meet any of the above inclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups

Frankincense essential oil + boswellic acid supplement

Experimental group

Description:

Participants in this arm take two capsules of a frankincense essential oil + boswellic acid supplement daily for approximately 30 days.

Treatment:

Dietary Supplement: Frankincense essential oil + boswellic acid supplement

Frankincense essential oil supplement

Active Comparator group

Description:

Participants in this arm take two capsules of a frankincense essential oil supplement daily for approximately 30 days.

Treatment:

Dietary Supplement: Frankincense essential oil supplement