Impact of Microbiome-changing Interventions on Food Decision-making
- Conditions
- Overweight and Obesity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: InulinBehavioral: Lifestyle intervention
- Registration Number
- NCT05353504
- Lead Sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- BMI >= 25 kg/m2 or WHR >= 0.9/0.85 (m/d, f)
- no MRI contra-indication
- written informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo dietary supplement Placebo equicaloric daily maltodextrin prebiotic dietary supplement Inulin high-dose daily inulin behavioural lifestyle intervention Lifestyle intervention new educational program to change eating behaviour, provided through weekly sessions.
- Primary Outcome Measures
Name Time Method blood-oxygenation-level-dependent (BOLD) activity during food wanting 6 months BOLD-acitvity will be measured using event-related echo-planar T2\*-weighted magnetic resonance imaging (MRI) during food wanting task according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Wanting rating scores (on an 8-point likert scale) per stimulus will be added as covariates. In a parallel model, kcal of food stimuli will be added multiplied with wanting scores to model high caloric food wanting interaction. At the group level, we will assess the contrasts food \> art and wanting modulation.
- Secondary Outcome Measures
Name Time Method ghrelin 6 months ghrelin pg/ml in blood
leptin 6 months leptin ng/ml in blood
executive attention performance 6 months measured using the attention network task (ANT)
food craving 6 months assessed with the food craving questionnaire (Meule et al., 2012, German version).
microbial alpha and beta diversity 6 months Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples
insulin 6 months insulin in blood uU/ml
fMRI BOLD activity memory performance 6 months BOLD-acitvity will be measured using event-related echo-planar T2\*-weighted magnetic resonance imaging (MRI) during food wanting and food memory recognition tasks according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation in encoding and recognition will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Correctly remembered and correctly rejected, as well as misses and false alarms will be modeled separately. In parallel models, similar and new items als well as wanting rating scores (on an 8-point likert scale) per stimulus and kcal of food stimuli multiplied with wanting scores will be added as covariates. At the group level, we will assess the contrasts correct \> false and wanting modulation.
satiety 6 months self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).
PYY 6 months peptide YY pg/ml in blood
HbA1c 6 months hemoglycated globulin A1c in blood %
microbial metabolic markers in blood 6 months short-chain fatty acids (SCFA), bile acids
body mass index 6 months weight kg/height in m squared
GLP-1 6 months Glucagon-like peptide-1 (GLP-1) pg/ml in blood
inflammatory markers 6 months high sensitive C-reactive protein mg/l (and optionally tumor necrosis factor alpha and interleukin 6 in blood, pg/ml)
waist hip ratio 6 months waist (cm) to hip (cm) circumeference ratio
body fat 6 months body fat % according to bioelectrical impedance analysis
Trial Locations
- Locations (1)
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
🇩🇪Leipzig, Germany