"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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight and Obesity
- Sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- blood-oxygenation-level-dependent (BOLD) activity during food wanting
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
blood-oxygenation-level-dependent (BOLD) activity during food wanting
Time Frame: 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 Outcomes
- body fat(6 months)
- ghrelin(6 months)
- leptin(6 months)
- executive attention performance(6 months)
- food craving(6 months)
- microbial alpha and beta diversity(6 months)
- insulin(6 months)
- fMRI BOLD activity memory performance(6 months)
- satiety(6 months)
- PYY(6 months)
- HbA1c(6 months)
- microbial metabolic markers in blood(6 months)
- body mass index(6 months)
- GLP-1(6 months)
- inflammatory markers(6 months)
- waist hip ratio(6 months)