Impact of Microbiome-changing Interventions on Food Decision-making
Recruiting · NCT05353504 · Interventional (participants receive a specific treatment) · Lead sponsor: Max Planck Institute for Human Cognitive and Brain Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- BMI \>= 25 kg/m2 or WHR \>= 0.9/0.85 (m/d, f)
- no MRI contra-indication
- written informed consent
Exclusion criteria
- 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
- previous bariatric/gastric surgery
- pregnancy or breastfeeding woman
Where it is running
1 location listed.
- Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences - Leipzig, Germany