Impact of Microbiome-changing Interventions on Food Decision-making

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMax Planck Institute for Human Cognitive and Brain Sciences

About this trial

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.

Eligibility criteria

Qualifiers

BMI >= 25 kg/m2 or WHR >= 0.9/0.85 (m/d, f)

no MRI contra-indication

written informed consent

Disqualifiers

athletes

occurrence of a clinically relevant psychiatric disease in the last 12 months, e.g. depression, substance abuse, eating disorders, schizophrenia

any chronic inflammatory or malignant disease

type 1 diabetes

Trial design

Treatments tested in this trial

  • Inulin
  • Lifestyle intervention
  • Placebo

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Max Planck Institute for Human Cognitive and Brain Sciences

Lead sponsor

Universitätsklinikum Leipzig

Collaborator

DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)

Collaborator

Helmholtz-Zentrum für Umweltforschung - UFZ

Collaborator