RecruitingNot ApplicableNCT05353504

Impact of Microbiome-changing Interventions on Food Decision-making

"SFB 1052/3 - Mechanismen Der Adipositas, Projekt A1: Veränderung Der Neurobiologischen Grundlagen Von Ess-Entscheidungen Bei Adipositas" Engl. "CRC 1052/3 - Obesity Mechanisms, Project A1: Targeting Neurobehavioral Determinants of Obesity"


Sponsor

Max Planck Institute for Human Cognitive and Brain Sciences

Enrollment

90 participants

Start Date

Mar 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

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

Exclusion Criteria6

  • 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

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Interventions

DIETARY_SUPPLEMENTInulin

28g/day delivered in 2 sachets throughout the day with main meals

BEHAVIORALLifestyle intervention

weekly educational sessions to improve individual's eating behaviour

DIETARY_SUPPLEMENTPlacebo

equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals


Locations(1)

Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, Germany

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NCT05353504


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