Набор скоро начнётся NCT07653815

Essential Oil-Based Product System for Digestive Support

Без фазы С лечением Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: essential oil supplement, Essential Oil, Placebo supplement, placebo essential oil.
Кому может быть актуально: Состояния в реестре: Healthy. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

Пищевая добавка 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.
Другое 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.
Пищевая добавка Placebo supplement
Placebo will be olive oil capsules of the same size and color as the active capsules.
Другое placebo essential oil
Placebo essential oil will contain fractionated coconut oil with diluted single constituent for aroma and food coloring.

Первичные конечные точки

GSRS [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

Gene expression [Срок оценки: 4 weeks]
Complete blood count (CBC) [Срок оценки: 4 weeks]
Gut microbiome test [Срок оценки: 4 weeks]
Digestion-associated Quality of Life Questionnaire (DQLQ) [Срок оценки: 4 weeks]
PROMIS Global Health survey [Срок оценки: 4 weeks]
Adverse events [Срок оценки: 4 weeks]
Albumin (g/dL) [Срок оценки: 4 weeks]
Blood urea nitrogen (BUN) (mg/dL) [Срок оценки: 4 weeks]
Creatinine (mg/dL) [Срок оценки: 4 weeks]
Alkaline phosphatase (U/L) [Срок оценки: 4 weeks]
Alanine transaminase (ALT) (U/L) [Срок оценки: 4 weeks]
Aspartate aminotransferase (AST) (U/L) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

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.