Impact of Microbiome-changing Interventions on Food Decision-making

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT05353504

Run by

Max Planck Institute for Human Cognitive and Brain Sciences

People needed

90

Starts

2022-03-08

Expected to finish

2026-12-01

Last updated by the study team

2022-04-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI >= 25 kg/m2 or WHR >= 0.9/0.85 (m/d, f)
• no MRI contra-indication
• written informed consent

You may not qualify if…

• 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

• Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences — Leipzig, Germany (enrolling)

Full record on ClinicalTrials.gov

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