Actively Recruiting
Impact of Microbiome-changing Interventions on Food Decision-making
Led by Max Planck Institute for Human Cognitive and Brain Sciences · Updated on 2022-04-29
90
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
M
Max Planck Institute for Human Cognitive and Brain Sciences
Lead Sponsor
U
Universitätsklinikum Leipzig
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Microbiome-changing Interventions on Food Decision-making
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI of 25 kg/m2 or higher or waist-to-hip ratio of 0.9 or higher for males, 0.85 or higher for females
- No contraindications for MRI scans
- Provided written informed consent
You will not qualify if you...
- Professional athletes
- Clinically relevant psychiatric diseases within the last 12 months, including depression, substance abuse, eating disorders, or schizophrenia
- Any chronic inflammatory or malignant diseases
- Type 1 diabetes
- Previous bariatric or gastric surgery
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Germany
Actively Recruiting
Research Team
M
Meghedi Vartanian, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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