HealthyNCT07653815
Essential Oil-Based Product System for Digestive Support
A study testing essential oil supplement and Essential Oil in people with Healthy, run by dōTERRA International at 1 site in United States.
Trial summary
This study aims to evaluate the efficacy of specific essential oils. Efficacy will be evaluated through changes, if any, to hsCRP, gene expression, and standard hematologic and metabolic parameters, as well as subjective health changes as measured by Gastrointestinal Symptom Rating Scale (GSRS), PROMIS Global Health… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- essential oil supplement and Essential Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old
- Willing to attend 2 study visits at Prime Meridian Health Clinic in Pleasant Grove, Utah
- Willing and able to undergo 2 blood draws over 4 weeks
- Willing to provide urine (females) and stool samples twice over 4 weeks
- Willing to wash out of all internally and topically used essential oils or botanical products for at least 2 weeks prior to starting the study, and willing to maintain the washout for the duration of the study (4 weeks)
- Willing and able to use study products as directed daily for about 4 weeks
Show all 16Show fewer
- Willing to avoid alcohol, recreational drugs, tobacco, and vaping for the duration of the study
- Willing to track use of study products
- Willing to maintain current sleep, diet, and exercise habits for the duration of the study
- No major diseases under treatment by doctor (Medical Reviewer's discretion)
- No pregnancy within the last 90 days or currently breastfeeding, or possibility of becoming pregnant.
- No allergy to any of the ingredients in the study products
- No regular consumption of the study products within the last 1 month
- No alcohol, recreational drug, tobacco, or 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 judgement of the medical provider, put the participant at risk or affect study results, procedures, or outcomes.
- Not currently or previously participating in another clinical trial within the last 30 calendar days.
Who cannot join
- Failure to meet all listed inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
doTERRA International
Pleasant Grove, Utah, 84062
Nicole Stevens, 8016157200, nstevens@doterra.com
About this study
Official title: Efficacy and Safety of an Essential Oil-Based Product System for Digestive Support
This study aims to evaluate the efficacy of specific essential oils. Efficacy will be evaluated through changes, if any, to hsCRP, gene expression, and standard hematologic and metabolic parameters, as well as subjective health changes as measured by Gastrointestinal Symptom Rating Scale (GSRS), PROMIS Global Health survey, PROMIS Fatigue Scale, Immune Fitness Item Scale (IFIS), and the Immune Status Questionnaire (ISQ) in healthy volunteers. The main questions it aims to answer are:
- Do specific essential oils affect gene expression and hematologic and metabolic parameters as measured in blood?
- How do essential oils affect gut microbiome?
- How does daily use of specific essential oils affect subjective quality of life and health parameters?
- Is ingesting and topically applying specific essential oils daily safe, as measured by laboratory tests and adverse events?
Read more
Two study products will be used: oil for topical use, supplement for internal use. The two products will be used together and compared to a placebo group. The topical oil contains a blend of ginger essential oil, peppermint essential oil, caraway essential oil, coriander essential oil, and anise essential oil. The supplement contains everything the oil has, plus anise essential oil.
Participants will:
- Be assigned one of the two groups.
- Use the oil topically once each day for 4 weeks.
- Take one supplement in the morning and one in the evening every day for 4 weeks.
- Attend 2 study visits in which they provide blood and urine (females only) samples.
- Complete 2 stool collection/microbiome kits
- Complete surveys and subjective health assessments
Read the detailed description
Digestive function plays a central role in daily comfort, quality of life, and overall well-being, even among generally healthy individuals. Many commercially available products are marketed to support normal digestive processes and gastrointestinal comfort; however, controlled human data evaluating their use under typical conditions in healthy populations remain limited. This study is designed to evaluate the tolerability, feasibility, and potential digestive-related effects of DigestZen when used as directed in a real-world context. DigestZen is a proprietary essential oil blend composed of Ginger, Peppermint, Caraway, Coriander, Anise, and Fennel essential oils, ingredients traditionally used to support digestive comfort and normal gastrointestinal function.
- Conditions
- Healthy
- Being tested
- essential oil supplement, Essential Oil, Placebo supplement, placebo essential oil
- Keywords
- gene expression, essential oils, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essential oil supplementDietary supplement
Internal use will entail ingesting Hypromellose capsules containing 135 mg essential oil and 365 mg extra virgin oil. The essential oils in the supplement are peppermint, coriander, ginger, caraway, cardamom, fennel, and anise. Participants will be instructed to take one capsule in the morning with food and one capsule in the evening with food, at least 3 hours before bedtime. Placebo will be olive oil capsules of the same size and color.
Essential OilOther
Topical use will entail applying the DigestZen oil blend diluted to 10% in fractionated coconut oil using a metered dropper. Participants will be instructed to add 2mL to the skin of the inner forearms and belly area and massage until oil has absorbed. The application will happen once per day at bedtime. Placebo will contain fractionated coconut oil with a diluted single constituent for aroma and food coloring.
Placebo supplementDietary supplement
Placebo will be olive oil capsules of the same size and color as the active capsules.
placebo essential oilOther
Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement and topical oil | Experimental | Participants take two capsules of the dietary supplement (one capsule in the morning and one in the evening) every day for 4 weeks. Participants will also place 2 mL of the oil on their forearms and stomach once daily at bedtime for 4 weeks. Receives: Dietary Supplement: essential oil supplement; Other: Essential Oil |
| Placebo | Placebo comparator | Participants assigned the placebo study products will follow the same use directions as those in the active group. Placebo topical oil will contain fractionated coconut oil with a diluted single constituent for aroma and food coloring. The placebo supplement group will take a supplement that contains olive oil, and will be the same size and color as the active supplement. Receives: Dietary Supplement: Placebo supplement; Other: placebo essential oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSRS
Looking for within- and between treatment changes to Gastrointestinal Symptom Rating Scale (GSRS) from baseline to completion. The GSRS uses a 7-point Likert scale for the 15 questions regarding gastrointestinal symptoms with answers ranging from "No discomfort at all" to "Very severe discomfort." Scores range from 15 to 105, and the total score is the sum of all item scores. Higher scores indicate more severe GI symptoms.
Measured: 4 weeks
Secondary outcomes (19)
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
Complete blood count (CBC)
Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count.
Measured: 4 weeks
Gut microbiome test
Participants complete stool collection kits. Stool is analyzed for gut microbiome composition (e.g. bacteria %/count/type)
Measured: 4 weeks
Digestion-associated Quality of Life Questionnaire (DQLQ)
Validated, self-reported scale for the measurement of digestion-associated quality of life outcomes. The DQLQ is a 9-item scale with total scores between 0 and 9. Each item is scored as a percentage 0-100, with 100 representing a score of 1. Higher scores indicate greater dissatisfaction with digestion-associated quality of life outcomes.
Measured: 4 weeks
PROMIS Global Health survey
Validated, self-reported scale that assesses overall health-related quality of life across physical, mental, and social domains. The PROMIS Global Health Survey (v1.2) is a 10-item scale, with items scored between 1 and 5 each. Higher scores are indicative of a healthier person, with exceptions to the questions related to fatigue where a higher score indicates greater fatigue.
Measured: 4 weeks
Adverse events
This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology/pregnancy testing (females).
Measured: 4 weeks
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dōTERRA International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Stevens, Principal investigator, doTERRA International LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653815
- Sponsor's protocol ID
- DO-126078-DZS
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2026
- Last updated
- 17 Jun 2026
- 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of an Essential Oil-Based Product System for Digestive Support
- ClinicalTrials.gov ID
- NCT07653815
- Acronym / sponsor ID
- DO-126078-DZS
- Conditions
- Healthy
- Keywords
- gene expression, essential oils, gut microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- dōTERRA InternationalIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (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.
This study aims to evaluate the efficacy of specific essential oils. Efficacy will be evaluated through changes, if any, to hsCRP, gene expression, and standard hematologic and metabolic parameters, as well as subjective health changes as measured by Gastrointestinal Symptom Rating Scale (GSRS), PROMIS Global Health survey, PROMIS Fatigue Scale, Immune Fitness Item Scale (IFIS), and the Immune Status Questionnaire (ISQ) in healthy volunteers. The main questions it aims to answer are:
- Do specific essential oils affect gene expression and hematologic and metabolic parameters as measured in blood?
- How do essential oils affect gut microbiome?
- How does daily use of specific essential oils affect subjective quality of life and health parameters?
- Is ingesting and topically applying specific essential oils daily safe, as measured by laboratory tests and adverse events?
Two study products will be used: oil for topical use, supplement for internal use. The two products will be used together and compared to a placebo group. The topical oil contains a blend of ginger essential oil, peppermint essential oil, caraway essential oil, coriander essential oil, and anise essential oil. The supplement contains everything the oil has, plus anise essential oil.
Participants will:
- Be assigned one of the two groups.
- Use the oil topically once each day for 4 weeks.
- Take one supplement in the morning and one in the evening every day for 4 weeks.
- Attend 2 study visits in which they provide blood and urine (females only) samples.
- Complete 2 stool collection/microbiome kits
- Complete surveys and subjective health assessments
Detailed description
Digestive function plays a central role in daily comfort, quality of life, and overall well-being, even among generally healthy individuals. Many commercially available products are marketed to support normal digestive processes and gastrointestinal comfort; however, controlled human data evaluating their use under typical conditions in healthy populations remain limited. This study is designed to evaluate the tolerability, feasibility, and potential digestive-related effects of DigestZen when used as directed in a real-world context. DigestZen is a proprietary essential oil blend composed of Ginger, Peppermint, Caraway, Coriander, Anise, and Fennel essential oils, ingredients traditionally used to support digestive comfort and normal gastrointestinal function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement and topical oil | Experimental | Dietary Supplement: essential oil supplement, Other: Essential OilParticipants take two capsules of the dietary supplement (one capsule in the morning and one in the evening) every day for 4 weeks. Participants will also place 2 mL of the oil on their forearms and stomach once daily at bedtime for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplement, Other: placebo essential oilParticipants assigned the placebo study products will follow the same use directions as those in the active group. Placebo topical oil will contain fractionated coconut oil with a diluted single constituent for aroma and food coloring. The placebo supplement group will take a supplement that contains olive oil, and will be the same size and color as the active supplement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 18-45 years old
- Willing to attend 2 study visits at Prime Meridian Health Clinic in Pleasant Grove, Utah
- Willing and able to undergo 2 blood draws over 4 weeks
- Willing to provide urine (females) and stool samples twice over 4 weeks
- Willing to wash out of all internally and topically used essential oils or botanical products for at least 2 weeks prior to starting the study, and willing to maintain the washout for the duration of the study (4 weeks)
Key exclusion criteria (1 listed)
- Failure to meet all listed 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 |
|---|---|---|
| essential oil supplementInternal use will entail ingesting Hypromellose capsules containing 135 mg essential oil and 365 mg extra virgin oil. The essential oils in the supplement are peppermint, coriander, ginger, caraway, cardamom, fennel, and anise. Participants will be instructed to take one capsule in the morning with food and one capsule in the evening with food, at least 3 hours before bedtime. Placebo will be olive oil capsules of the same size and color. | Dietary supplement | Dietary supplement and topical oil |
| Essential OilTopical use will entail applying the DigestZen oil blend diluted to 10% in fractionated coconut oil using a metered dropper. Participants will be instructed to add 2mL to the skin of the inner forearms and belly area and massage until oil has absorbed. The application will happen once per day at bedtime. Placebo will contain fractionated coconut oil with a diluted single constituent for aroma and food coloring. | Other | Dietary supplement and topical oil |
| Placebo supplementPlacebo will be olive oil capsules of the same size and color as the active capsules. | Dietary supplement | Placebo |
| placebo essential oilPlacebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring. | Other | Placebo |
Primary outcome
GSRS
Time frame: 4 weeks
Looking for within- and between treatment changes to Gastrointestinal Symptom Rating Scale (GSRS) from baseline to completion. The GSRS uses a 7-point Likert scale for the 15 questions regarding gastrointestinal symptoms with answers ranging from "No discomfort at all" to "Very severe discomfort." Scores range from 15 to 105, and the total score is the sum of all item scores. Higher scores indicate more severe GI symptoms.
19 secondary outcomes
Gene expression
Time frame: 4 weeks
Complete blood count (CBC)
Time frame: 4 weeks
Gut microbiome test
Time frame: 4 weeks
Digestion-associated Quality of Life Questionnaire (DQLQ)
Time frame: 4 weeks
PROMIS Global Health survey
Time frame: 4 weeks
Adverse events
Time frame: 4 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- 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.
Nicole Stevens principal investigator
doTERRA International LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing essential oil supplement and Essential Oil 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 16 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: opening soon, as of the sponsor's last update on 17 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Stevens (8016157200, nstevens@doterra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GSRS (time frame: 4 weeks). 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 17 Jun 2026.