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Impact of Microbiome-changing Interventions on Food Decision-making

Recruiting
18 - 60 years of age
Both
Phase N/A

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Overview

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

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

Study details

Overweight and Obesity

NCT05353504

Max Planck Institute for Human Cognitive and Brain Sciences

26 January 2024

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