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Completed

NCT Number: NCT06488417

Frankincense Supplements and Inflammation

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

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

doTERRA International

Pleasant Grove, Utah, 84062, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frankincense essential oil + boswellic acid supplement

Dietary Supplement

This supplement contains frankincense essential oil and boswellic acid as its active ingredients.

Frankincense essential oil supplement

Dietary Supplement

This supplement contains frankincense essential oil as its active ingredient.

Primary outcomes

  1. Gene expression

    Time frame: 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.

  2. Interleukin 6 (pg/mL)

    Time frame: 4 weeks

    Serum marker for inflammation

  3. Fasting insulin (uIU/mL)

    Time frame: 4 weeks

    Serum marker used to determine whether insulin levels are affected by the consumption of the study product.

  4. Matrix metalloproteinase-9 (ELISA)

    Time frame: 4 weeks

    Serum protein involved in inflammatory response and tissue remodeling

  5. High sensitivity C-reactive protein (mg/L)

    Time frame: 4 weeks

    Serum marker for inflammation and cardiac health

Secondary outcomes

  1. Albumin (g/dL)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  2. Blood urea nitrogen (BUN) (mg/dL)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  3. Creatinine (mg/dL

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  4. Alkaline phosphatase (U/L)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  5. Alanine transaminase (ALT) (U/L)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  6. Aspartate aminotransferase (AST) (U/L)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  7. Calcium (mg/dL)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  8. Carbon Dioxide (mmol/L)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  9. Chloride (mmol/L)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  10. Potassium (mmol/L)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  11. Sodium (mmol/L)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  12. Total bilirubin (mg/dL)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  13. Total protein (g/dL)

    Time frame: 4 weeks

    Item in comprehensive metabolic panel for safety assessment

  14. Body mass index (BMI)

    Time frame: 4 weeks

    Determine whether body mass index is affected by the consumption of the study product.

  15. Blood pressure (mmHg)

    Time frame: 4 weeks

    Determine whether blood pressure is affected by the consumption of the study product.

  16. Heart rate (BPM)

    Time frame: 4 weeks

    Determine whether heart rate is affected by the consumption of the study product.

  17. Waist circumference (cm)

    Time frame: 4 weeks

    Determine whether waist circumference is affected by the consumption of the study product.

  18. White blood cells (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  19. Red blood cells (x10E6/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  20. Hemoglobin (g/dL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  21. Hematocrit (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  22. Mean corpuscular volume (fL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  23. Mean corpuscular hemoglobin (pg)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  24. Mean corpuscular hemoglobin concentration (g/dL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  25. Red cell distribution width (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  26. Platelets (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  27. Neutrophils (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  28. Lymphocytes (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  29. Monocytes (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  30. Eosinophils (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  31. Basophils (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  32. Neutrophils (Absolute) (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  33. Lymphocytes (Absolute) (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  34. Monocytes (Absolute) (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  35. Eosinophils (Absolute) (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  36. Basophils (Absolute) (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  37. Immature granulocytes (%)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  38. Immature granulocytes (Absolute) (x10E3/uL)

    Time frame: 4 weeks

    Item in complete blood count for safety assessment

  39. Safety/tolerability

    Time frame: 4 weeks

    This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology analyses.

  40. Generalized Anxiety Disorder-7 (GAD-7) scale

    Time frame: 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.

  41. Patient Health Questionnaire (PHQ-8) scale

    Time frame: 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.

  42. Leeds Sleep Evaluation Questionnaire (LSEQ) scale

    Time frame: 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.

  43. Short Form-20 (SF-20) scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

dōTERRA International

Industry

Registry information

Official study title

Evaluation of Frankincense Essential Oil Supplements on Markers of Inflammation and Cellular Health

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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