Impact of Microbiome-changing Interventions on Food Decision-making

The investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. To this end, 90 overweight/obese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. Before and after the intervention/control period, participants will undergo task-based functional and structural MRI and cognitive testing. The gut microbiota will be assessed using 16S rDNA next-generation sequencing (V3/V4 region) in stool samples. Diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. SCFA). Using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. Related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.

NCT Number	NCT05353504
Lead Sponsor	Max Planck Institute for Human Cognitive and Brain Sciences Collaborators: Universitätsklinikum Leipzig, DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation), Helmholtz-Zentrum für Umweltforschung - UFZ
Conditions	Overweight and Obesity
Enrollment	90 participants
Start Date	2022-03-08
Primary Completion	2024-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2022-04-29