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Идёт набор NCT07618000

PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition

Без фазы С лечением Heathly Volunteers

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: PI-YSP-0111 formulation (High-dose), PI-YSP-0111 formulation (Low-dose), Placebo group(High-dose), Placebo group(Low-dose).
Кому может быть актуально
Состояния в реестре: Heathly Volunteers. Базовые параметры: 18 лет — 65 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of the Effects of the PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition

Обзор

The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health.

Подробное описание

All participants will undergo blood, urine, and fecal sample collection at baseline and after 8 weeks of supplementation. Body composition measurements and questionnaire assessments will be conducted at baseline, after 4 weeks, and after 8 weeks of supplementation. The collected data will be analyzed using a two-way mixed-design analysis of variance (ANOVA) to compare both between-group and within-group differences.

Вмешательства

  • Пищевая добавка PI-YSP-0111 formulation (High-dose)
    6 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
  • Пищевая добавка PI-YSP-0111 formulation (Low-dose)
    4 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)
  • Пищевая добавка Placebo group(High-dose)
    6 per day(Maltose powder, Aerosil, Magnesium Stearate)
  • Пищевая добавка Placebo group(Low-dose)
    4 per day(Maltose powder, Aerosil, Magnesium Stearate)

Первичные конечные точки

  • Serum Ketone Bodies [Срок оценки: week0 and week8]
  • Albumin [Срок оценки: Week0 and week8]
  • Aspartate Aminotransferase (AST) [Срок оценки: week0 and week8]
  • Alanine Aminotransferase (ALT) [Срок оценки: week0 and week8]
  • Gamma-Glutamyl Transferase (GGT) [Срок оценки: week0 and week8]
  • Blood Creatinine [Срок оценки: week0 and week8]
  • Blood Urea Nitrogen (BUN) [Срок оценки: week0 and week8]
  • Uric Acid [Срок оценки: week0 and week8]
  • Sodium (Na⁺) [Срок оценки: week0 and week8]
  • Potassium (K⁺) [Срок оценки: week0 and week8]

Критерии участия

Критерии включения

  • Healthy males or females aged 18 to 65 years.
  • BMI between 23.0 and 40.0 kg/m².
  • Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females.
  • Participants are willing to maintain their usual dietary habits, daily routines, and physical activity levels during the study period, and have no plans to relocate.
  • Participants have fully understood the study procedures and have signed the informed consent form.

Критерии исключения

  • Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery.
  • Recent history of acute gastroenteritis, constipation or diarrhea; psychiatric disorders (e.g., depression or schizophrenia); cardiovascular diseases (e.g., hypertension); known allergy or hypersensitivity to the investigational product; extreme dietary habits; significant body weight change (>4.5 kg) within the past three months; recent use of antibiotics or antifungal agents; or use of medications affecting gastrointestinal function (such as probiotics, laxatives, or nonsteroidal anti-inflammatory drugs \[NSAIDs\]).
  • Exposure to unapproved medications, alcohol abuse, or substance abuse.
  • Female-specific conditions, including significant gastrointestinal symptoms during menstruation, irregular menstrual cycles, pregnancy, planned pregnancy, or breastfeeding (participants who become pregnant during the study period will also be excluded).
  • Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month.
  • Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months.
  • Participation in any other interventional clinical study within the past one month.
  • History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer.
  • Occurrence of major trauma or any surgical procedures within the past one month.
  • History of diabetic ketoacidosis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Тайвань · 2 центра
  • Taipei Medical University — Taipei
  • Taipei Municipal WanFang Hospital(Managed by Taipei Medical University) — Taipei

Идентификаторы

NCT: NCT07618000 · N202603016

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗