Effects of dietary changes on food choices and brain function
"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"
This study is testing if changing diets can help overweight and obese adults make better food choices and improve their brain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Max Planck Institute for Human Cognitive and Brain Sciences Academic / other |
| Locations | 1 site (Leipzig) |
| Trial ID | NCT05353504 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how dietary interventions that alter the gut microbiome can influence food decision-making in overweight and obese adults. A total of 90 participants will be randomly assigned to receive either a pre-biotic dietary intervention, a behavioral lifestyle intervention, or a control condition over 26 weeks. The study will utilize functional and structural MRI, cognitive testing, and microbiota analysis through stool samples to assess changes in brain function and gut health. The goal is to understand the mechanisms behind how diet impacts food choices and overall health.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight or obese adults with a BMI of 25 kg/m2 or higher.
Not a fit: Patients with clinically relevant psychiatric diseases, chronic inflammatory or malignant diseases, or those who have undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new dietary strategies that improve food decision-making and aid in weight management for individuals with obesity.
How similar studies have performed: While the specific approach of this study may be novel, previous research has shown promising results in the relationship between gut microbiota and dietary interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leipzig
- Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences — Leipzig, Germany (Recruiting)
Study contacts
- Principal investigator: Veronica Witte, PhD — Cognitive Neurology, University Medical Center Leipzig
- Study coordinator: Meghedi Vartanian, MSc
- Email: mi-food@cbs.mpg.de
- Phone: +49(0)341/9940-951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.