Essential Oil-Based Product System for Digestive Support

Official title

Efficacy and Safety of an Essential Oil-Based Product System for Digestive Support

Overview

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: 1. Do specific essential oils affect gene expression and hematologic and metabolic parameters as measured in blood? 2. How do essential oils affect gut microbiome? 3. How does daily use of specific essential oils affect subjective quality of life and health parameters? 4. 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.

Interventions

• Dietary supplement essential oil 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.
• Other Essential Oil
  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.
• Dietary supplement Placebo supplement
  Placebo will be olive oil capsules of the same size and color as the active capsules.
• Other placebo essential oil
  Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.

Primary outcome measures

• GSRS [Time frame: 4 weeks]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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
• 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.

Exclusion criteria

• Failure to meet all listed inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• doTERRA International — Pleasant Grove

Identifiers

NCT: NCT07653815 · DO-126078-DZS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗