Impact of Microbiome-changing Interventions on Food Decision-making
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inulin, Lifestyle intervention, Placebo.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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"
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.
Interventions
- Dietary supplement Inulin
28g/day delivered in 2 sachets throughout the day with main meals - Behavioral Lifestyle intervention
weekly educational sessions to improve individual's eating behaviour - Dietary supplement Placebo
equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals
Primary outcome measures
- blood-oxygenation-level-dependent (BOLD) activity during food wanting [Time frame: 6 months]
Secondary outcome measures (12)
- microbial alpha and beta diversity [Time frame: 6 months]
- fMRI BOLD activity memory performance [Time frame: 6 months]
- satiety [Time frame: 6 months]
- ghrelin [Time frame: 6 months]
- leptin [Time frame: 6 months]
- GLP-1 [Time frame: 6 months]
- PYY [Time frame: 6 months]
- insulin [Time frame: 6 months]
- HbA1c [Time frame: 6 months]
- inflammatory markers [Time frame: 6 months]
- microbial metabolic markers in blood [Time frame: 6 months]
- body mass index [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences — Leipzig
Publications
- Vartanian M, Endres KJ, Lee YT, Friedrich S, Meemken MT, Schamarek I, Rohde-Zimmermann K, Schurfeld R, Eisenberg L, Hilbert A, Beyer F, Stumvoll M, Sacher J, Villringer A, Christensen JF, Witte AV. Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol. BMC Nutr. 2025 Jan 13;11(1):8. doi: 10.1186/s40795-024-00971-6. PMID 39806493
Identifiers
NCT: NCT05353504 · MIFOOD