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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBuchinger Wilhelmi Development & Holding GmbH

About this trial

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.

Eligibility criteria

Qualifiers

Men and women

Age: 18-65 years old

Fasting for 10±4 days at the Buchinger Wilhelmi clinic in Überlingen

BMI ≥ 25 kg/m²

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fibre Arm
  • Control Arm

Treatment groups

75 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Buchinger Wilhelmi Development & Holding GmbH

Lead sponsor

Buchinger Wilhelmi Clinic, 88662 Überlingen, Germany

Collaborator

King's College London, Faculty of Life Sciences & Medicine, Department of Nutritional Sciences, London, United Kingdom

Collaborator

Leiden University Medical Center, Department Leiden University Center for Infectious Diseases, 2333ZA, Leiden, Netherlands

Collaborator

TNO, Department Microbiology & Systems Biology, 2333 BE Leiden, Netherlands

Collaborator

Università degli Studi di Milano, Department of Pharmacological and Biomolecular Sciences Rodolfo Paoletti, Milan, Italy

Collaborator

Department of Cardio-Thoracic-Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Collaborator