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RECRUITING
NCT05353504
NA

Impact of Microbiome-changing Interventions on Food Decision-making

Sponsor: Max Planck Institute for Human Cognitive and Brain Sciences

View on ClinicalTrials.gov

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.

Official title: "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"

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2022-03-08

Completion Date

2026-12

Last Updated

2022-04-29

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences

Leipzig, Germany