Essential Oil-Based Product System for Digestive Support
2026年6月15日 更新者：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
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nicole Stevens
- 電話番号：8016157200
- メール：nstevens@doterra.com
研究連絡先のバックアップ
- 名前：Russell Osguthorpe
- 電話番号：8016157200
- メール：rosguthorpe@doterra.com
研究場所
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Utah
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Pleasant Grove、Utah、アメリカ、84062
- dōTERRA International
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コンタクト：
- Nicole Stevens
- 電話番号：8016157200
- メール：nstevens@doterra.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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GSRS
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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アルブミン (g/dL)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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血中尿素窒素 (BUN) (mg/dL)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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アルカリホスファターゼ (U/L)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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アラニントランスアミナーゼ (ALT) (U/L)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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アスパラギン酸アミノトランスフェラーゼ (AST) (U/L)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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カルシウム (mg/dL)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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塩化物(mmol/L)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
|
4週間
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カリウム (mmol/L)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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ナトリウム (mmol/L)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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総ビリルビン (mg/dL)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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総タンパク質 (g/dL)
時間枠：4週間
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安全性評価のための総合代謝部会の項目
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4週間
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Gene expression
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：4 weeks
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Item in comprehensive metabolic panel for safety assessment
|
4 weeks
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Carbon dioxide (mmol/L)
時間枠：4 weeks
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Item in comprehensive metabolic panel for safety assessment
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4 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nicole Stevens、doTERRA International LLC
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年11月1日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年3月9日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。