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

RecruitingNAAges 18 Years - 65 YearsAllBuchinger Wilhelmi Development & Holding GmbH
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In plain words

What the trial is, and whether it could suit you

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 supplement

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Fibre Arm
  • Control Arm
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Where

1 site
Buchinger Wilhelmi Development & Holding
Überlingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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