HealthyNCT06488417
Frankincense Supplements and Inflammation
A study testing Frankincense essential oil + boswellic acid supplement and Frankincense essential oil supplement in people with Healthy, run by dōTERRA International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Frankincense essential oil + boswellic acid supplement and Frankincense essential oil supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 21 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- Failure to meet any of the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Frankincense Essential Oil Supplements on Markers of Inflammation and Cellular Health
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:
- Do frankincense essential oil supplements affect gene expression and protein markers as measured in blood?
- How does daily ingestion of frankincense supplements affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?
- How does daily ingestion of frankincense essential oil supplements affect subjective quality of life and health parameters?
- Is ingesting frankincense essential oil supplements daily safe, as measured by laboratory tests and adverse events?
Read more
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
Read the 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.
- Conditions
- Healthy
- Being tested
- Frankincense essential oil + boswellic acid supplement, Frankincense essential oil supplement
- Keywords
- Frankincense essential oil, Boswellic acid, Gene expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frankincense essential oil + boswellic acid supplementDietary supplement
This supplement contains frankincense essential oil and boswellic acid as its active ingredients.
Frankincense essential oil supplementDietary supplement
This supplement contains frankincense essential oil as its active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Frankincense essential oil + boswellic acid supplement | Experimental | Participants in this arm take two capsules of a frankincense essential oil + boswellic acid supplement daily for approximately 30 days. Receives: Dietary Supplement: Frankincense essential oil + boswellic acid supplement |
| Frankincense essential oil supplement | Active comparator | Participants in this arm take two capsules of a frankincense essential oil supplement daily for approximately 30 days. Receives: Dietary Supplement: Frankincense essential oil supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Interleukin 6 (pg/mL)
Serum marker for inflammation
Measured: 4 weeks
Fasting insulin (uIU/mL)
Serum marker used to determine whether insulin levels are affected by the consumption of the study product.
Measured: 4 weeks
Matrix metalloproteinase-9 (ELISA)
Serum protein involved in inflammatory response and tissue remodeling
Measured: 4 weeks
High sensitivity C-reactive protein (mg/L)
Serum marker for inflammation and cardiac health
Measured: 4 weeks
Secondary outcomes (43)
Albumin (g/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Blood urea nitrogen (BUN) (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Creatinine (mg/dL
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Alkaline phosphatase (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Alanine transaminase (ALT) (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Aspartate aminotransferase (AST) (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Calcium (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Carbon Dioxide (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Chloride (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Potassium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Sodium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Total bilirubin (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Total protein (g/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 4 weeks
Body mass index (BMI)
Determine whether body mass index is affected by the consumption of the study product.
Measured: 4 weeks
Blood pressure (mmHg)
Determine whether blood pressure is affected by the consumption of the study product.
Measured: 4 weeks
Heart rate (BPM)
Determine whether heart rate is affected by the consumption of the study product.
Measured: 4 weeks
Waist circumference (cm)
Determine whether waist circumference is affected by the consumption of the study product.
Measured: 4 weeks
White blood cells (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Red blood cells (x10E6/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Hemoglobin (g/dL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Hematocrit (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Mean corpuscular volume (fL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Mean corpuscular hemoglobin (pg)
Item in complete blood count for safety assessment
Measured: 4 weeks
Mean corpuscular hemoglobin concentration (g/dL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Red cell distribution width (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Platelets (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Neutrophils (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Lymphocytes (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Monocytes (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Eosinophils (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Basophils (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Neutrophils (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Lymphocytes (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Monocytes (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Eosinophils (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Basophils (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 4 weeks
Immature granulocytes (%)
Item in complete blood count for safety assessment
Measured: 4 weeks
Immature granulocytes (Absolute) (x10E3/uL)
Item in complete blood count for safety assessment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start17 Jun 2024
- Primary completion12 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- dōTERRA International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Stevens, PhD, Principal investigator, doTERRA International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488417
- Sponsor's protocol ID
- DO-124033-FRA
- Status last verified
- Aug 2024
- First submitted
- 28 Jun 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Frankincense Essential Oil Supplements on Markers of Inflammation and Cellular Health
- ClinicalTrials.gov ID
- NCT06488417
- Acronym / sponsor ID
- DO-124033-FRA
- Conditions
- Healthy
- Keywords
- Frankincense essential oil, Boswellic acid, Gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- dōTERRA InternationalIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do frankincense essential oil supplements affect gene expression and protein markers as measured in blood?
- How does daily ingestion of frankincense supplements affect anthropometric measurements, including body mass index, waist circumference, blood pressure, and heart rate?
- How does daily ingestion of frankincense essential oil supplements affect subjective quality of life and health parameters?
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frankincense essential oil + boswellic acid supplement | Experimental | Dietary Supplement: Frankincense essential oil + boswellic acid supplementParticipants in this arm take two capsules of a frankincense essential oil + boswellic acid supplement daily for approximately 30 days. |
| Frankincense essential oil supplement | Active comparator | Dietary Supplement: Frankincense essential oil supplementParticipants in this arm take two capsules of a frankincense essential oil supplement daily for approximately 30 days. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet any of the above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frankincense essential oil + boswellic acid supplementThis supplement contains frankincense essential oil and boswellic acid as its active ingredients. | Dietary supplement | Frankincense essential oil + boswellic acid supplement |
| Frankincense essential oil supplementThis supplement contains frankincense essential oil as its active ingredient. | Dietary supplement | Frankincense essential oil supplement |
Primary outcome
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.
Interleukin 6 (pg/mL)
Time frame: 4 weeks
Serum marker for inflammation
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.
Matrix metalloproteinase-9 (ELISA)
Time frame: 4 weeks
Serum protein involved in inflammatory response and tissue remodeling
High sensitivity C-reactive protein (mg/L)
Time frame: 4 weeks
Serum marker for inflammation and cardiac health
43 secondary outcomes
Albumin (g/dL)
Time frame: 4 weeks
Blood urea nitrogen (BUN) (mg/dL)
Time frame: 4 weeks
Creatinine (mg/dL
Time frame: 4 weeks
Alkaline phosphatase (U/L)
Time frame: 4 weeks
Alanine transaminase (ALT) (U/L)
Time frame: 4 weeks
Aspartate aminotransferase (AST) (U/L)
Time frame: 4 weeks
Calcium (mg/dL)
Time frame: 4 weeks
Carbon Dioxide (mmol/L)
Time frame: 4 weeks
Chloride (mmol/L)
Time frame: 4 weeks
Potassium (mmol/L)
Time frame: 4 weeks
Sodium (mmol/L)
Time frame: 4 weeks
Total bilirubin (mg/dL)
Time frame: 4 weeks
Total protein (g/dL)
Time frame: 4 weeks
Body mass index (BMI)
Time frame: 4 weeks
Blood pressure (mmHg)
Time frame: 4 weeks
Heart rate (BPM)
Time frame: 4 weeks
Waist circumference (cm)
Time frame: 4 weeks
White blood cells (x10E3/uL)
Time frame: 4 weeks
Red blood cells (x10E6/uL)
Time frame: 4 weeks
Hemoglobin (g/dL)
Time frame: 4 weeks
Hematocrit (%)
Time frame: 4 weeks
Mean corpuscular volume (fL)
Time frame: 4 weeks
Mean corpuscular hemoglobin (pg)
Time frame: 4 weeks
Mean corpuscular hemoglobin concentration (g/dL)
Time frame: 4 weeks
Red cell distribution width (%)
Time frame: 4 weeks
Platelets (x10E3/uL)
Time frame: 4 weeks
Neutrophils (%)
Time frame: 4 weeks
Lymphocytes (%)
Time frame: 4 weeks
Monocytes (%)
Time frame: 4 weeks
Eosinophils (%)
Time frame: 4 weeks
Basophils (%)
Time frame: 4 weeks
Neutrophils (Absolute) (x10E3/uL)
Time frame: 4 weeks
Lymphocytes (Absolute) (x10E3/uL)
Time frame: 4 weeks
Monocytes (Absolute) (x10E3/uL)
Time frame: 4 weeks
Eosinophils (Absolute) (x10E3/uL)
Time frame: 4 weeks
Basophils (Absolute) (x10E3/uL)
Time frame: 4 weeks
Immature granulocytes (%)
Time frame: 4 weeks
Immature granulocytes (Absolute) (x10E3/uL)
Time frame: 4 weeks
Safety/tolerability
Time frame: 4 weeks
Generalized Anxiety Disorder-7 (GAD-7) scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Stevens, PhD principal investigator
doTERRA International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frankincense essential oil + boswellic acid supplement and Frankincense essential oil supplement in people with Healthy, run by dōTERRA International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.