Frankincense Supplements and Inflammation
NCT Number: NCT06488417
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Frankincense essential oil + boswellic acid supplement|DIETARY_SUPPLEMENT: Frankincense essential oil supplement
Sponsor: dōTERRA International
Sex: ALL
Age: ADULT
Enrollment: 67
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-06-17
Completion Date: 2024-08-21
Locations: doTERRA International, Pleasant Grove, Utah, 84062, United States

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

Primary Outcome Measures: Gene expression, 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., 4 weeks|Interleukin 6 (pg/mL), Serum marker for inflammation, 4 weeks|Fasting insulin (uIU/mL), Serum marker used to determine whether insulin levels are affected by the consumption of the study product., 4 weeks|Matrix metalloproteinase-9 (ELISA), Serum protein involved in inflammatory response and tissue remodeling, 4 weeks|High sensitivity C-reactive protein (mg/L), Serum marker for inflammation and cardiac health, 4 weeks
Secondary Outcome Measures: Albumin (g/dL), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Blood urea nitrogen (BUN) (mg/dL), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Creatinine (mg/dL, Item in comprehensive metabolic panel for safety assessment, 4 weeks|Alkaline phosphatase (U/L), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Alanine transaminase (ALT) (U/L), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Aspartate aminotransferase (AST) (U/L), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Calcium (mg/dL), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Carbon Dioxide (mmol/L), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Chloride (mmol/L), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Potassium (mmol/L), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Sodium (mmol/L), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Total bilirubin (mg/dL), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Total protein (g/dL), Item in comprehensive metabolic panel for safety assessment, 4 weeks|Body mass index (BMI), Determine whether body mass index is affected by the consumption of the study product., 4 weeks|Blood pressure (mmHg), Determine whether blood pressure is affected by the consumption of the study product., 4 weeks|Heart rate (BPM), Determine whether heart rate is affected by the consumption of the study product., 4 weeks|Waist circumference (cm), Determine whether waist circumference is affected by the consumption of the study product., 4 weeks|White blood cells (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Red blood cells (x10E6/uL), Item in complete blood count for safety assessment, 4 weeks|Hemoglobin (g/dL), Item in complete blood count for safety assessment, 4 weeks|Hematocrit (%), Item in complete blood count for safety assessment, 4 weeks|Mean corpuscular volume (fL), Item in complete blood count for safety assessment, 4 weeks|Mean corpuscular hemoglobin (pg), Item in complete blood count for safety assessment, 4 weeks|Mean corpuscular hemoglobin concentration (g/dL), Item in complete blood count for safety assessment, 4 weeks|Red cell distribution width (%), Item in complete blood count for safety assessment, 4 weeks|Platelets (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Neutrophils (%), Item in complete blood count for safety assessment, 4 weeks|Lymphocytes (%), Item in complete blood count for safety assessment, 4 weeks|Monocytes (%), Item in complete blood count for safety assessment, 4 weeks|Eosinophils (%), Item in complete blood count for safety assessment, 4 weeks|Basophils (%), Item in complete blood count for safety assessment, 4 weeks|Neutrophils (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Lymphocytes (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Monocytes (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Eosinophils (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Basophils (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Immature granulocytes (%), Item in complete blood count for safety assessment, 4 weeks|Immature granulocytes (Absolute) (x10E3/uL), Item in complete blood count for safety assessment, 4 weeks|Safety/tolerability, This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses., 4 weeks|Generalized Anxiety Disorder-7 (GAD-7) scale, 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., 4 weeks|Patient Health Questionnaire (PHQ-8) scale, 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., 4 weeks|Leeds Sleep Evaluation Questionnaire (LSEQ) scale, 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., 4 weeks|Short Form-20 (SF-20) scale, 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., 4 weeks