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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| essential oil supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Stevens | Contact | 8016157200 | nstevens@doterra.com | |
| Russell Osguthorpe | Contact | 8016157200 | rosguthorpe@doterra.com |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Stevens | doTERRA International LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| doTERRA International | Pleasant Grove | Utah | 84062 | United States |
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| ID | Term |
|---|---|
| D009822 | Oils, Volatile |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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| Essential Oil | Other | 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. |
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| Placebo supplement | Dietary Supplement | Placebo will be olive oil capsules of the same size and color as the active capsules. |
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| placebo essential oil | Other | Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring. |
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| Complete blood count (CBC) | Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count. | 4 weeks |
| Gut microbiome test | Participants complete stool collection kits. Stool is analyzed for gut microbiome composition (e.g. bacteria %/count/type) | 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. | 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. | 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). | 4 weeks |
| 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 |