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Набор скоро начнётся NCT07691736

Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits

Без фазы С лечением Fasting Dietary Fibre Gut Microbiome Metabolism Changes

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: Fibre Arm, Control Arm.
Кому может быть актуально
Состояния в реестре: Fasting, Dietary Fibre, Gut Microbiome, Metabolism Changes. 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
Германия
Следующий шаг
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Обзор

This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health. Whether long-term fasting and dietary fibre interventions could be combined to achieve synergistic improvements in host metabolic health is however unknown. The goal is to provide a proof of concept in a human trial that supplementing 10±4 days fasting with dietary fibre synergistically improves metabolic outcomes via gut microbiome-mediated effects. To assess this, we aim to analyse gut microbiome changes, functional outputs, and key metabolic markers such as butyrate production, glycaemic control and ketosis. The randomised controlled trial includes 75 participants and has two arms: one involving fasting with fibre supplementation (n = 50) and one involving fasting without fibre supplementation (n = 25). All participants will undergo a fasting period of 10±4 days according to the Buchinger Wilhelmi protocol, followed by a stepwise reintroduction of food of up to 4 days. As dietary fibre we will use maize-derived resistant starch type IV, selected based on its ability to stimulate beneficial gut microbes like Oscillibacter and corn starch as placebo. Two main visits will be conducted: before and at the end of the fasting period. During these visits, blood and stool samples will be collected, and questionnaires will be completed. Additionally, daily measurements of anthropometric parameters and well-being will be recorded. Stool samples will also be collected one month afterwards as a follow-up. Participants' metabolic health will be evaluated through various clinical parameters (e.g., body measurements, blood pressure, glycaemic control, ketones, well-being). Additionally, multi-omics data, including metagenomics and metabolomics, will provide insight into the composition of the microbiome, as well as its outputs and functions. Furthermore, the effects of fasting on extracellular vesicles in blood will be explored.

Вмешательства

  • Пищевая добавка Fibre Arm
    10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 20 g/day of maize-derived resistant starch type IV.
  • Пищевая добавка Control Arm
    10±4 days of fasting according to the Buchinger Wilhelmi fasting protocol, followed by a structured food reintroduction period, combined with 1.2 g/day of corn starch placebo.

Первичные конечные точки

  • Abundance of butyrate-producing gut bacteria [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
  • Change in fasting venous plasma glucose [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
Вторичные конечные точки (7)
  • Change in body weight [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
  • Change in body mass index [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
  • Change in waist circumference [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
  • Change in HbA1c [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
  • Change in HOMA index [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
  • Change in fasting venous insulin [Срок оценки: Baseline (T0) and end of the 10±4-day fasting period (T1)]
  • Change in glycaemic control assessed by continuous glucose monitoring [Срок оценки: From Day 1 through Day 14]

Критерии участия

Критерии включения

  • Men and women
  • Age: 18-65 years old
  • Fasting for 10±4 days at the Buchinger Wilhelmi clinic in Überlingen
  • BMI ≥ 25 kg/m²
  • Signed informed consent

Критерии исключения

  • intake of antibiotics up to 2 months prior the study
  • regular intake of pre-, post- and probiotics up to 2 months prior the study
  • diagnosed Crohn's disease, Ulcerative colitis, IBD, coeliac disease
  • medicated high blood pressure
  • diagnosed diabetes mellitus type I
  • medicated diabetes mellitus type II
  • diagnosed kidney stone
  • active malignant disease
  • known substance addiction
  • pregnancy or breastfeeding
  • diagnosed with cachexia, anorexia nervosa, advanced kidney, liver or cerebrovascular insufficiency
  • inability to sign the informed consent
  • participation in another study

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
Профилактика

Центры проведения

Германия · 1 центр
  • Buchinger Wilhelmi Development & Holding — Überlingen

Идентификаторы

NCT: NCT07691736 · F-2026-010

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗