Essential Oil-Based Product System for Digestive Support
2026년 6월 15일 업데이트: dōTERRA International
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?
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
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Nicole Stevens
- 전화번호: 8016157200
- 이메일: nstevens@doterra.com
연구 연락처 백업
- 이름: Russell Osguthorpe
- 전화번호: 8016157200
- 이메일: rosguthorpe@doterra.com
연구 장소
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Utah
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Pleasant Grove, Utah, 미국, 84062
- dōTERRA International
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연락하다:
- Nicole Stevens
- 전화번호: 8016157200
- 이메일: nstevens@doterra.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Dietary supplement and topical oil
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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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.
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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위약 비교기: Placebo
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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Placebo will be olive oil capsules of the same size and color as the active capsules.
Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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GSRS
기간: 4 weeks
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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.
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4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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알부민(g/dL)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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혈액요소질소(BUN)(mg/dL)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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알칼리성 포스파타제(U/L)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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알라닌 트랜스아미나제(ALT)(U/L)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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아스파르테이트 아미노트랜스퍼라제(AST)(U/L)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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칼슘(mg/dL)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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염화물(mmol/L)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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칼륨(mmol/L)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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나트륨(mmol/L)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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총 빌리루빈(mg/dL)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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총 단백질(g/dL)
기간: 4 주
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안전성 평가를 위한 대사종합패널 항목
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4 주
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Gene expression
기간: 4 weeks
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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.
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4 weeks
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Complete blood count (CBC)
기간: 4 weeks
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Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count.
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4 weeks
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Gut microbiome test
기간: 4 weeks
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Participants complete stool collection kits.
Stool is analyzed for gut microbiome composition (e.g.
bacteria %/count/type)
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4 weeks
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Digestion-associated Quality of Life Questionnaire (DQLQ)
기간: 4 weeks
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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.
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4 weeks
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PROMIS Global Health survey
기간: 4 weeks
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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.
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4 weeks
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Adverse events
기간: 4 weeks
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This study will monitor the occurrence and frequency of adverse events and safety, both through participant report and blood chemistry/hematology/pregnancy testing (females).
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4 weeks
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Creatinine (mg/dL)
기간: 4 weeks
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Item in comprehensive metabolic panel for safety assessment
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4 weeks
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Carbon dioxide (mmol/L)
기간: 4 weeks
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Item in comprehensive metabolic panel for safety assessment
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4 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Nicole Stevens, doTERRA International LLC
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 11월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 3월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .