NCT05353504Recruiting
Impact of Microbiome-changing Interventions on Food Decision-making
"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"
Source: ClinicalTrials.gov · Last updated 29 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 23 Mar 2022
- Start date
- 8 Mar 2022
- Primary completion date
- Dec 2024
- Lead sponsor
- Max Planck Institute for Human Cognitive and Brain Sciences
- Diseases
- Obesity
- NCT number
- NCT05353504
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 8 Mar 2022 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous bariatric/gastric surgery
Other illness
- 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
Other
- athletes
- pregnancy or breastfeeding woman
Who the study is looking for
- BMI \>= 25 kg/m2 or WHR \>= 0.9/0.85 (m/d, f)
- no MRI contra-indication
- written informed consent
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.