Healthy
Conditions
Keywords
Frankincense essential oil, Boswellic acid, Gene expression
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.
Interventions
DIETARY_SUPPLEMENTFrankincense essential oil + boswellic acid supplement
This supplement contains frankincense essential oil and boswellic acid as its active ingredients.
DIETARY_SUPPLEMENTFrankincense essential oil supplement
This supplement contains frankincense essential oil as its active ingredient.
Sponsors
dōTERRA International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Matrix metalloproteinase-9 (ELISA) | 4 weeks | Serum protein involved in inflammatory response and tissue remodeling |
| High sensitivity C-reactive protein (mg/L) | 4 weeks | Serum marker for inflammation and cardiac health |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Carbon Dioxide (mmol/L) | 4 weeks | Item in comprehensive metabolic panel for safety assessment |
| Chloride (mmol/L) | 4 weeks | Item in comprehensive metabolic panel for safety assessment |
| 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 |
| Total bilirubin (mg/dL) | 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. |
| 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. |
| Waist circumference (cm) | 4 weeks | Determine whether waist circumference 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 |
| Hemoglobin (g/dL) | 4 weeks | Item in complete blood count for safety assessment |
| Hematocrit (%) | 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 |
| 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. |
| Mean corpuscular hemoglobin concentration (g/dL) | 4 weeks | Item in complete blood count 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 |
| Neutrophils (%) | 4 weeks | Item in complete blood count for safety assessment |
| Lymphocytes (%) | 4 weeks | Item in complete blood count 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 |
| Basophils (%) | 4 weeks | Item in complete blood count for safety assessment |
| Neutrophils (Absolute) (x10E3/uL) | 4 weeks | Item in complete blood count for safety assessment |
| Lymphocytes (Absolute) (x10E3/uL) | 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 |
| Basophils (Absolute) (x10E3/uL) | 4 weeks | Item in complete blood count for safety assessment |
| 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. |
| 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. |
| Immature granulocytes (%) | 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. |
| 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. |
| Immature granulocytes (Absolute) (x10E3/uL) | 4 weeks | Item in complete blood count for safety assessment |
| Albumin (g/dL) | 4 weeks | Item in comprehensive metabolic panel for safety assessment |
| Blood urea nitrogen (BUN) (mg/dL) | 4 weeks | Item in comprehensive metabolic panel for safety assessment |
| Creatinine (mg/dL | 4 weeks | Item in comprehensive metabolic panel for safety assessment |
Countries
United States
Outcome results
None listed