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Clinical Trials in Germany / NCT05353504
Recruiting Not applicable

Impact of Microbiome-changing Interventions on Food Decision-making

NCT05353504 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2022-03-08
Last updated
2022-04-29

Condition(s) studied

Overweight and Obesity

Investigational drug(s) / intervention(s)

InulinLifestyle interventionPlacebo

Inulin: 28g/day delivered in 2 sachets throughout the day with main meals

Lifestyle intervention: weekly educational sessions to improve individual's eating behaviour

Placebo: equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences Leipzig Germany Recruiting

More Max Planck Institute for Human Cognitive and Brain Sciences trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05353504 on ClinicalTrials.gov ↗ ← All trials in Germany