Efficacy and Safety of an Essential Oil-Based Product System for Digestive Support
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Failure to meet all listed inclusion criteria