Impact of Microbiome-changing Interventions on Food Decision-making

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

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

Sponsors & Collaborators

• Universitätsklinikum Leipzig

  collaborator OTHER

• DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)

  collaborator UNKNOWN

• Helmholtz-Zentrum für Umweltforschung - UFZ

  collaborator UNKNOWN

• Max Planck Institute for Human Cognitive and Brain Sciences

  lead OTHER

Principal Investigators

• Veronica Witte, PhD · Cognitive Neurology, University Medical Center Leipzig

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-08

Primary Completion

2024-12-31

Completion

2026-12-31

Countries

• Germany

Study Locations