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Идёт набор NCT07504029

Human Clinical Trial Evaluating the Blood Glucose-Regulating Effects of Momordica Charantia Peptides

Без фазы С лечением People With Prediabetic

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: BmpP® Momordica charantia Peptide Capsules.
Кому может быть актуально
Состояния в реестре: People With Prediabetic. Базовые параметры: 30 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
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Обзор

Prediabetes is a metabolic condition characterized by elevated blood glucose levels that are higher than normal but below the diagnostic threshold for diabetes. Early intervention to improve glycemic control may help delay the progression to type 2 diabetes. Momordica charantia (bitter melon) peptides have been reported to possess potential glucose-regulating effects. This study aims to evaluate the effects of BmpP® bitter melon peptide supplementation on glycemic control in adults with prediabetes. This study is designed as a 12-week single-arm, open-label clinical trial. Approximately 12 adults aged 30-65 years with prediabetes will be recruited. Participants will consume bitter melon peptide capsules three times daily before meals for 12 weeks. Primary outcomes include fasting blood glucose, postprandial glucose response, and HbA1c levels. The findings of this study may provide preliminary evidence regarding the potential role of bitter melon peptides in blood glucose regulation.

Вмешательства

  • Пищевая добавка BmpP® Momordica charantia Peptide Capsules
    Participants will consume one capsule of BmpP® bitter melon peptide before each meal (three capsules per day) with approximately 200 mL of water for 12 weeks. Blood glucose levels, HbA1c, and other metabolic parameters will be evaluated through blood sampling and oral glucose tolerance tests (OGTT) at baseline and week 12.

Первичные конечные точки

  • 2-hour Glucose Area Under the Curve (2h-gluAUC) [Срок оценки: Baseline (Week 0) and Week 12]
  • Maximum Incremental Blood Glucose (maxΔBG) [Срок оценки: Baseline (Week 0) and Week 12]
  • Glycated Hemoglobin (HbA1c) [Срок оценки: Baseline (Week 0) and Week 12]

Критерии участия

Критерии включения

  • Adults aged 30-65 years, both male and female.
  • Participants meeting any of the following criteria for prediabetes:
  • Fasting blood glucose 100-125 mg/dL
  • HbA1c 5.7-6.4%
  • Previous clinical records indicating 2-hour OGTT glucose levels of 140-199 mg/dL
  • Body mass index (BMI) between 24-35 kg/m², with waist circumference recorded (men ≥90 cm; women ≥80 cm).
  • Stable lifestyle (including diet, physical activity, and sleep habits) during the past three months.
  • No use of blood glucose-regulating supplements prior to or during the study.
  • Willingness to comply with study procedures and complete all required assessments.
  • Provision of written informed consent.

Критерии исключения

  • Diagnosis of type 2 diabetes mellitus (HbA1c ≥6.5% or physician diagnosis).
  • Current use of antidiabetic medications (e.g., metformin, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, or insulin).
  • Use of medications that may affect blood glucose levels, such as corticosteroids, antipsychotic drugs, or unstable thyroid medications.
  • Presence of severe hepatic, renal, cardiovascular diseases, active cancer, or gastrointestinal malabsorption disorders.
  • Pregnant or breastfeeding women, or those planning to become pregnant.
  • Body weight change exceeding ±5% within the past three months, or currently following a weight-loss program or special diet.
  • History of alcohol abuse or substance misuse.
  • Individuals engaged in night shift or rotating shift work.
  • Known allergy to any component of the study product.
  • Participation in another clinical trial within the past 1 month, or antibiotic use within the past 8 weeks (if gut microbiota analysis is involved).
  • Individuals who are students currently taught by Associate Professor You-Cheng Shen or Dr. Jing-Bin Lin, or laboratory staff, assistants, or employees with a supervisory or subordinate relationship with the investigators.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Тайвань · 1 центр
  • Chung Shan Medical University — Taichung

Идентификаторы

NCT: NCT07504029 · CS1-25192

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗