Frankincense Supplements and Inflammation
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Frankincense essential oil supplementDietary Supplement: Frankincense essential oil + boswellic acid supplement
- Registration Number
- NCT06488417
- Lead Sponsor
- dōTERRA International
- 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 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
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
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
- Failure to meet any of the above inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Frankincense essential oil supplement Frankincense essential oil supplement Participants in this arm take two capsules of a frankincense essential oil supplement daily for approximately 30 days. Frankincense essential oil + boswellic acid supplement Frankincense essential oil + boswellic acid supplement Participants in this arm take two capsules of a frankincense essential oil + boswellic acid supplement daily for approximately 30 days.
- Primary Outcome Measures
Name Time Method High sensitivity C-reactive protein (mg/L) 4 weeks Serum marker for inflammation and cardiac health
Gene expression 4 weeks Gene expression analysis refers to a genome-wide quantification of methylation. EPIC850k array will be used for methylation analysis. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another.
Matrix metalloproteinase-9 (ELISA) 4 weeks Serum protein involved in inflammatory response and tissue remodeling
Interleukin 6 (pg/mL) 4 weeks Serum marker for inflammation
Fasting insulin (uIU/mL) 4 weeks Serum marker used to determine whether insulin levels are affected by the consumption of the study product.
- Secondary Outcome Measures
Name Time Method Alkaline phosphatase (U/L) 4 weeks Item in comprehensive metabolic panel for safety assessment
Alanine transaminase (ALT) (U/L) 4 weeks Item in comprehensive metabolic panel for safety assessment
Chloride (mmol/L) 4 weeks Item in comprehensive metabolic panel for safety assessment
Blood pressure (mmHg) 4 weeks Determine whether blood pressure is affected by the consumption of the study product.
Heart rate (BPM) 4 weeks Determine whether heart rate is affected by the consumption of the study product.
White blood cells (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Red blood cells (x10E6/uL) 4 weeks Item in complete blood count for safety assessment
Neutrophils (%) 4 weeks Item in complete blood count for safety assessment
Lymphocytes (Absolute) (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Immature granulocytes (Absolute) (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Safety/tolerability 4 weeks This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses.
Generalized Anxiety Disorder-7 (GAD-7) scale 4 weeks Validated, self-reported scale for the measurement of anxiety severity. The GAD-7 is a 7-item scale with total scores between 0 and 21. Higher scores indicate higher anxiety severity.
Albumin (g/dL) 4 weeks Item in comprehensive metabolic panel for safety assessment
Aspartate aminotransferase (AST) (U/L) 4 weeks Item in comprehensive metabolic panel for safety assessment
Calcium (mg/dL) 4 weeks Item in comprehensive metabolic panel for safety assessment
Total bilirubin (mg/dL) 4 weeks Item in comprehensive metabolic panel for safety assessment
Waist circumference (cm) 4 weeks Determine whether waist circumference is affected by the consumption of the study product.
Basophils (Absolute) (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Creatinine (mg/dL 4 weeks Item in comprehensive metabolic panel for safety assessment
Carbon Dioxide (mmol/L) 4 weeks Item in comprehensive metabolic panel for safety assessment
Total protein (g/dL) 4 weeks Item in comprehensive metabolic panel for safety assessment
Body mass index (BMI) 4 weeks Determine whether body mass index is affected by the consumption of the study product.
Hemoglobin (g/dL) 4 weeks Item in complete blood count for safety assessment
Hematocrit (%) 4 weeks Item in complete blood count for safety assessment
Short Form-20 (SF-20) scale 4 weeks Validated, self-reported scale for the assessment of subjective quality of life. The SF-20 is a 20-item scale. Each item is scored 0-100. Higher scores indicate better subjective quality of life.
Potassium (mmol/L) 4 weeks Item in comprehensive metabolic panel for safety assessment
Sodium (mmol/L) 4 weeks Item in comprehensive metabolic panel for safety assessment
Red cell distribution width (%) 4 weeks Item in complete blood count for safety assessment
Platelets (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Basophils (%) 4 weeks Item in complete blood count for safety assessment
Blood urea nitrogen (BUN) (mg/dL) 4 weeks Item in comprehensive metabolic panel for safety assessment
Monocytes (%) 4 weeks Item in complete blood count for safety assessment
Eosinophils (%) 4 weeks Item in complete blood count for safety assessment
Neutrophils (Absolute) (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Mean corpuscular volume (fL) 4 weeks Item in complete blood count for safety assessment
Mean corpuscular hemoglobin (pg) 4 weeks Item in complete blood count for safety assessment
Mean corpuscular hemoglobin concentration (g/dL) 4 weeks Item in complete blood count for safety assessment
Lymphocytes (%) 4 weeks Item in complete blood count for safety assessment
Monocytes (Absolute) (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Eosinophils (Absolute) (x10E3/uL) 4 weeks Item in complete blood count for safety assessment
Immature granulocytes (%) 4 weeks Item in complete blood count for safety assessment
Patient Health Questionnaire (PHQ-8) scale 4 weeks Validated, self-reported scale for the measurement of depression severity. The PHQ-8 is an 8-item scale with total scores between 0 and 12. Higher scores indicate higher depression severity.
Leeds Sleep Evaluation Questionnaire (LSEQ) scale 4 weeks Validated, self-reported scale for the measurement of sleep quality. The LSEQ is a 10-item scale. Each item is scored 0 to 100. Higher scores indicate better sleep quality.
Trial Locations
- Locations (1)
doTERRA International
🇺🇸Pleasant Grove, Utah, United States