Меню
Идёт набор NCT07460856

Effects of Cranberry on Gut and Metabolic Health

Без фазы С лечением Overweight/Obesity Metabolic Syndrome Insulin Resistance Microbiota

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: Cranberry beverage, Placebo beverage.
Кому может быть актуально
Состояния в реестре: Overweight/Obesity, Metabolic Syndrome, Insulin Resistance, Microbiota. Базовые параметры: 25 лет — 70 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
Канада
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 →

Обзор

The consumption of plant-based foods, particularly berries, has been associated with improved health due to their high content of bioactive compounds. Among these, polyphenols-especially proanthocyanidins (PACs)-may offer protective effects against chronic diseases related to overweight and obesity. Cranberries are naturally rich in PACs and may positively influence metabolic health by modulating the gut microbiota. However, their specific effects on intestinal integrity and broader metabolic outcomes remain underexplored. The primary aim of this study is to assess the effects of cranberry supplementation on glucose metabolism, insulin sensitivity, blood lipid levels, and the composition and function of the gut microbiota in overweight and obese individuals. This randomized, double-blind, placebo-controlled, crossover clinical trial will include two 12-week intervention periods-one with a cranberry beverage and one with a placebo-separated by a 4-week washout period and preceded by a 2-week lifestyle stabilization phase. Participants will undergo comprehensive metabolic assessments (glucose control, insulin sensitivity, lipid profile), body composition analysis, gut microbiota profiling, and liver fat imaging (MRI in a subsample of female participants). Additional evaluations will include markers of inflammation, appetite regulation, intestinal health, and lifestyle factors.

Вмешательства

  • Пищевая добавка Cranberry beverage
    Daily consumption of 240 ml of cranberry beverage for 12 weeks.
  • Пищевая добавка Placebo beverage
    Daily consumption of 240 ml of placebo beverage for 12 weeks.

Первичные конечные точки

  • Change in glucose homeostasis [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in insulin secretion [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in insulin secretion [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in lipid profile [Срок оценки: Pre and post each treatment (12 week/each)]
Вторичные конечные точки (9)
  • Change in other measures of glucose homeostasis [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in blood pressure [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in chronic inflammation [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in anthropometric measurements [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in anthropometric measurements [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in body composition [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in gut microbiota [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in gut microbiota function [Срок оценки: Pre and post each treatment (12 week/each)]
  • Change in fat accumulation in the liver [Срок оценки: Pre and post each treatment (12 week/each)]

Критерии участия

Критерии включения

  • body mass index between 25 and 40 kg/m2
  • at least one of the following criteria: fasting plasma insulin >60 pmol/L, fasting glycemia between 5.5 and 6.9 mmol/L, glycated hemoglobin (HbA1c) level of 5.7- 6.4% and/or fasting triglyceride >1.35 mmol/L.

Критерии исключения

  • to have aversion to cranberry products
  • regularly drinking alcohol (>2 glasses/day)
  • having a significant change in body weight in the past 3 months (±5% of their body weight) due to bariatric surgery or other conditions
  • taking medication which may affect the study outcomes (i.e. antidiabetic and/or cholesterol or lipid-lowering medications and/or glucocorticosteroid in supraphysiological doses and/or anti-obesity medications)
  • taking regular probiotics and prebiotics (including fruit/berry polyphenol supplements) in the past 3 months
  • having eating disorders
  • had undergone major surgery 3 months prior to the study or if they had one planned
  • if they had intestinal malabsorption, cirrhosis or chronic kidney disease
  • being pregnant, planning a pregnancy, or breastfeeding.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Канада · 1 центр
  • INAF, Université Laval — Québec

Идентификаторы

NCT: NCT07460856 · CRANOS 2024-530

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗