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Набор скоро начнётся NCT07379931

Evaluating a Liquid Extract of Carob to Improve Blood Sugar in People With Prediabetes

Без фазы С лечением Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

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: Carob extract, Control product.
Кому может быть актуально
Состояния в реестре: Prediabetes (Insulin Resistance, Impaired Glucose Tolerance). 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
Испания
Следующий шаг
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Официальное название

Randomized Clinical Trial to Analyze the Efficacy of a Liquid Carob Extract on the Glucose Metabolism of Subjects With Prediabetes.

Обзор

This study evaluates whether a liquid carob extract can improve blood glucose levels in individuals with prediabetes. Participants are selected according to predefined health criteria and randomly assigned to two groups: one group receives the carob extract and the other receives an inert liquid (placebo). Blood samples are collected and glucose-related parameters are measured throughout the study to assess changes over time. The objective is to determine whether this extract may contribute to better glycemic control and help prevent progression to diabetes.

Подробное описание

This study is designed to assess the efficacy of a carob extract on glucose metabolism in individuals presenting impaired fasting glucose or elevated glycated hemoglobin levels, without current antidiabetic pharmacological treatment. Participants will consume the extract for 90 days, and metabolic outcomes will be compared with baseline values.

Secondary objectives include assessing changes in glucose area under the curve and peak glucose levels following an oral glucose tolerance test; evaluating variations in fasting glucose and fasting insulin levels after 90 days of intake; and determining changes in peripheral insulin resistance using the HOMA-IR and QUICKI indices. Additionally, potential effects on body composition will be assessed in individuals with abnormal fasting glucose or HbA1c values. Product safety will be monitored and analyzed throughout the study period.

Вмешательства

  • Пищевая добавка Carob extract
    Consumo durante 90 días. La dosis diaria del producto es de 6,66 g/día, dividida en dos dosis de 3,33 g/dosis al día. El producto debe tomarse 30 minutos antes de las dos comidas principales del día.
  • Пищевая добавка Control product
    Identical characteristics to the product under study. Consumption for 90 days, twice a day.

Первичные конечные точки

  • Area under the curve (AUC) of blood glucose during the oral glucose tolerance test [Срок оценки: This assessment will be performed at baseline, on day 45, and on day 90.]
  • Glycosylated hemoglobin (HbA1c) [Срок оценки: Measurements will be taken at baseline, on day 45, and on day 90.]
Вторичные конечные точки (5)
  • Area under the curve (AUC) of blood insulin during the oral glucose tolerance test [Срок оценки: This assessment will be performed at the start of the study, on day 45, and on day 90.]
  • Insulin resistance and insulin sensitivity indices [Срок оценки: Both indices will be calculated at baseline, day 45, and day 90.]
  • Body composition analysis [Срок оценки: These measurements will be taken at the beginning, on day 45, and on day 90.]
  • Liver safety variables [Срок оценки: These measurements will be performed at baseline, on day 45, and on day 90.]
  • Adverse events [Срок оценки: At 12 weeks after consumption]

Критерии участия

Критерии включения

  • Subjects of both sexes aged between 18 and 65.
  • Diagnosis of prediabetes according to the American Diabetes Association (at least one of the following criteria):
  • Impaired fasting glucose (100-125 mg/dL)
  • Glucose intolerance (oral glucose tolerance test with blood glucose between 140-199 mg/dL after 2 hours).
  • Glycated hemoglobin between 5.7 and 6.4%
  • Subjects with a body mass index between 20-35 kg/m2.
  • Stable eating habits: no weight gain or loss of more than 5 kg in the last ten weeks.
  • Volunteers capable of understanding the clinical study and willing to comply with the study procedures and requirements.

Критерии исключения

  • Use of medications that may interfere with glucose metabolism.
  • Subjects with a history of any type of liver or kidney disease.
  • Alcohol consumption greater than 20 g/day.
  • History of allergic hypersensitivity or poor tolerance to any component of the products under study.
  • Participation in another clinical trial in the three months prior to the study.
  • Unwillingness or inability to comply with clinical trial procedures.
  • Pregnant or breastfeeding women.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

Испания · 1 центр
  • UCAM HiTech, Sport & Health Innovation Hub — Murcia

Идентификаторы

NCT: NCT07379931 · UCAMCFE-00037

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗