NCT05353504 Impact of Microbiome-changing Interventions on Food Decision-making
| NCT ID | NCT05353504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Max Planck Institute for Human Cognitive and Brain Sciences |
| Condition | Overweight and Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-03-08 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2022-03-08 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: * 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
Contact & Investigator
Veronica Witte, PhD
PRINCIPAL INVESTIGATOR
Cognitive Neurology, University Medical Center Leipzig
Frequently Asked Questions
Who can join the NCT05353504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Overweight and Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05353504 currently recruiting?
Yes, NCT05353504 is actively recruiting participants. Contact the research team at mi-food@cbs.mpg.de for enrollment information.
Where is the NCT05353504 trial being conducted?
This trial is being conducted at Leipzig, Germany.
Who is sponsoring the NCT05353504 clinical trial?
NCT05353504 is sponsored by Max Planck Institute for Human Cognitive and Brain Sciences. The principal investigator is Veronica Witte, PhD at Cognitive Neurology, University Medical Center Leipzig. The trial plans to enroll 90 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.