Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol

Abstract Background Obesity is a multifactorial disease reaching pandemic proportions with increasing healthcare costs, advocating the development of better prevention and treatment strategies. Previous research indicates that the gut microbiome plays an important role in metabolic, hormonal, and ne...

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Main Authors: Meghedi Vartanian, Konrad Jakob Endres, Yee Teng Lee, Silke Friedrich, Marie-Theres Meemken, Imke Schamarek, Kerstin Rohde-Zimmermann, Robin Schürfeld, Lina Eisenberg, Anja Hilbert, Frauke Beyer, Michael Stumvoll, Julia Sacher, Arno Villringer, Julia F. Christensen, A. Veronica Witte
Format: Article
Language:English
Published: BMC 2025-01-01
Series:BMC Nutrition
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Online Access:https://doi.org/10.1186/s40795-024-00971-6
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author Meghedi Vartanian
Konrad Jakob Endres
Yee Teng Lee
Silke Friedrich
Marie-Theres Meemken
Imke Schamarek
Kerstin Rohde-Zimmermann
Robin Schürfeld
Lina Eisenberg
Anja Hilbert
Frauke Beyer
Michael Stumvoll
Julia Sacher
Arno Villringer
Julia F. Christensen
A. Veronica Witte
author_facet Meghedi Vartanian
Konrad Jakob Endres
Yee Teng Lee
Silke Friedrich
Marie-Theres Meemken
Imke Schamarek
Kerstin Rohde-Zimmermann
Robin Schürfeld
Lina Eisenberg
Anja Hilbert
Frauke Beyer
Michael Stumvoll
Julia Sacher
Arno Villringer
Julia F. Christensen
A. Veronica Witte
author_sort Meghedi Vartanian
collection DOAJ
description Abstract Background Obesity is a multifactorial disease reaching pandemic proportions with increasing healthcare costs, advocating the development of better prevention and treatment strategies. Previous research indicates that the gut microbiome plays an important role in metabolic, hormonal, and neuronal cross-talk underlying eating behavior. We therefore aim to examine the effects of prebiotic and neurocognitive behavioral interventions on food decision-making and to assay the underlying mechanisms in a Randomized Controlled Trial (RCT). Method This study uses a parallel arm RCT design with a 26-week intervention period. We plan to enroll 90 participants (male/diverse/female) living with overweight or obesity, defined as either a Waist-to-Hip Ratio (WHR) ≥ 0.9 (male)/0.85 (diverse, female) or a Body Mass Index (BMI) ≥ 25 kg/m2. Key inclusion criteria are 18–60 years of age and exclusion criteria are type 2 diabetes, psychiatric disease, and Magnetic Resonance Imaging (MRI) contraindications. The interventions comprise either a daily supplementary intake of 30 g soluble fiber (inulin), or weekly neurocognitive behavioral group sessions, compared to placebo (equicaloric maltodextrin). At baseline and follow-up, food decision-making is assessed utilizing task-based MRI. Secondary outcome measures include structural MRI, eating habits, lifestyle factors, personality traits, and mood. Further, we obtain fecal and blood samples to investigate gut microbiome composition and related metabolites. Discussion This study relies on expanding research suggesting that dietary prebiotics could improve gut microbiome composition, leading to beneficial effects on gut-brain signaling and higher-order cognitive functions. In parallel, neurocognitive behavioral interventions have been proposed to improve unhealthy eating habits and metabolic status. However, causal evidence on how these “bottom-up” and “top-down” processes affect food decision-making and neuronal correlates in humans is still scarce. In addition, microbiome, and gut-brain-axis-related mediating mechanisms remain unclear. The present study proposes a comprehensive approach to assess the effects of these gut-brain-related processes influencing food decision-making in overweight and obesity. Trial registration ClinicalTrials.gov NCT05353504. Retrospectively registered on 29 April 2022.
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spelling doaj-art-739f04f4f237426e967bcb910d4085b32025-01-19T12:13:19ZengBMCBMC Nutrition2055-09282025-01-0111111510.1186/s40795-024-00971-6Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocolMeghedi Vartanian0Konrad Jakob Endres1Yee Teng Lee2Silke Friedrich3Marie-Theres Meemken4Imke Schamarek5Kerstin Rohde-Zimmermann6Robin Schürfeld7Lina Eisenberg8Anja Hilbert9Frauke Beyer10Michael Stumvoll11Julia Sacher12Arno Villringer13Julia F. Christensen14A. Veronica Witte15Clinic for Cognitive Neurology, University of Leipzig Medical CenterClinic for Cognitive Neurology, University of Leipzig Medical CenterClinic for Cognitive Neurology, University of Leipzig Medical CenterClinic for Cognitive Neurology, University of Leipzig Medical CenterClinic for Cognitive Neurology, University of Leipzig Medical CenterDepartment of Medicine III, Division of Endocrinology, Nephrology and Rheumatology, University of LeipzigHelmholtz Institute for Metabolic, Obesity and Vascular Research (HI-MAG), Helmholtz Center Munich at the University of Leipzig and the University Hospital LeipzigDepartment of Medicine III, Division of Endocrinology, Nephrology and Rheumatology, University of LeipzigClinic for Cognitive Neurology, University of Leipzig Medical CenterIntegrated Research and Treatment Center AdiposityDiseases, Behavioral Medicine Research Unit, Department of Psychosomatic Medicine and Psychotherapy, University of Leipzig Medical CenterClinic for Cognitive Neurology, University of Leipzig Medical CenterDepartment of Medicine III, Division of Endocrinology, Nephrology and Rheumatology, University of LeipzigClinic for Cognitive Neurology, University of Leipzig Medical CenterClinic for Cognitive Neurology, University of Leipzig Medical CenterDepartment of Cognitive Neuropsychology, Max Planck Institute for Empirical AestheticsClinic for Cognitive Neurology, University of Leipzig Medical CenterAbstract Background Obesity is a multifactorial disease reaching pandemic proportions with increasing healthcare costs, advocating the development of better prevention and treatment strategies. Previous research indicates that the gut microbiome plays an important role in metabolic, hormonal, and neuronal cross-talk underlying eating behavior. We therefore aim to examine the effects of prebiotic and neurocognitive behavioral interventions on food decision-making and to assay the underlying mechanisms in a Randomized Controlled Trial (RCT). Method This study uses a parallel arm RCT design with a 26-week intervention period. We plan to enroll 90 participants (male/diverse/female) living with overweight or obesity, defined as either a Waist-to-Hip Ratio (WHR) ≥ 0.9 (male)/0.85 (diverse, female) or a Body Mass Index (BMI) ≥ 25 kg/m2. Key inclusion criteria are 18–60 years of age and exclusion criteria are type 2 diabetes, psychiatric disease, and Magnetic Resonance Imaging (MRI) contraindications. The interventions comprise either a daily supplementary intake of 30 g soluble fiber (inulin), or weekly neurocognitive behavioral group sessions, compared to placebo (equicaloric maltodextrin). At baseline and follow-up, food decision-making is assessed utilizing task-based MRI. Secondary outcome measures include structural MRI, eating habits, lifestyle factors, personality traits, and mood. Further, we obtain fecal and blood samples to investigate gut microbiome composition and related metabolites. Discussion This study relies on expanding research suggesting that dietary prebiotics could improve gut microbiome composition, leading to beneficial effects on gut-brain signaling and higher-order cognitive functions. In parallel, neurocognitive behavioral interventions have been proposed to improve unhealthy eating habits and metabolic status. However, causal evidence on how these “bottom-up” and “top-down” processes affect food decision-making and neuronal correlates in humans is still scarce. In addition, microbiome, and gut-brain-axis-related mediating mechanisms remain unclear. The present study proposes a comprehensive approach to assess the effects of these gut-brain-related processes influencing food decision-making in overweight and obesity. Trial registration ClinicalTrials.gov NCT05353504. Retrospectively registered on 29 April 2022.https://doi.org/10.1186/s40795-024-00971-6Gut-Brain axisPrebioticsNeurocognitive behavioral interventionMicrobiomeMRIEating behavior
spellingShingle Meghedi Vartanian
Konrad Jakob Endres
Yee Teng Lee
Silke Friedrich
Marie-Theres Meemken
Imke Schamarek
Kerstin Rohde-Zimmermann
Robin Schürfeld
Lina Eisenberg
Anja Hilbert
Frauke Beyer
Michael Stumvoll
Julia Sacher
Arno Villringer
Julia F. Christensen
A. Veronica Witte
Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol
BMC Nutrition
Gut-Brain axis
Prebiotics
Neurocognitive behavioral intervention
Microbiome
MRI
Eating behavior
title Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol
title_full Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol
title_fullStr Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol
title_full_unstemmed Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol
title_short Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol
title_sort investigating the impact of microbiome changing interventions on food decision making mifood study protocol
topic Gut-Brain axis
Prebiotics
Neurocognitive behavioral intervention
Microbiome
MRI
Eating behavior
url https://doi.org/10.1186/s40795-024-00971-6
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