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

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 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

Description

Eligibility