Clinical trial NCT05353504: Impact of Microbiome-changing Interventions on Food Decision-making
Official title: "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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Max Planck Institute for Human Cognitive and Brain Sciences
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
name: DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)
name: Helmholtz-Zentrum für Umweltforschung - UFZ
First posted: 2022-04-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 criteria: 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

Primary outcomes:
measure: blood-oxygenation-level-dependent (BOLD) activity during food wanting
timeFrame: 6 months
Secondary outcomes:
measure: microbial alpha and beta diversity
timeFrame: 6 months
measure: fMRI BOLD activity memory performance
timeFrame: 6 months
measure: satiety
timeFrame: 6 months
measure: ghrelin
timeFrame: 6 months
measure: leptin
timeFrame: 6 months
measure: GLP-1
timeFrame: 6 months
measure: PYY
timeFrame: 6 months
measure: insulin
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: inflammatory markers
timeFrame: 6 months
measure: microbial metabolic markers in blood
timeFrame: 6 months
measure: body mass index
timeFrame: 6 months
measure: waist hip ratio
timeFrame: 6 months
measure: body fat
timeFrame: 6 months
measure: food craving
timeFrame: 6 months
measure: executive attention performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
Study officials:
affiliation: Cognitive Neurology, University Medical Center Leipzig
name: Veronica Witte, PhD
role: PRINCIPAL_INVESTIGATOR
References: