NCT05353504

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"

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Max Planck Institute for Human Cognitive and Brain Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Inulin	28g/day delivered in 2 sachets throughout the day with main meals
BEHAVIORAL	Lifestyle intervention	weekly educational sessions to improve individual's eating behaviour
DIETARY_SUPPLEMENT	Placebo	equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals

Timeline

• Start date: 2022-03-08
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: Germany