Impact of Microbiome-changing Interventions on Food Decision-making (MIFOOD)

"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"

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Inulin; Behavioral: Lifestyle intervention; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghedi Vartanian, MSc; Phone Number: +49(0)341/9940-951; Email: mi-food@cbs.mpg.de

Study Locations

• Germany
  • Leipzig, Germany
    • Recruiting
    • Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
    • Contact: Meghedi Vartanian, Msc; Phone Number: +49(0)341/9940-954; Email: mi-food@cbs.mpg.de
    • Contact: Silke Friedrich; Phone Number: +49(0)341/9940-954; Email: mi-food@cbs.mpg.de
    • Principal Investigator: Veronica Witte, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prebiotic dietary supplement; high-dose daily inulin	Dietary supplement: Inulin; 28g/day delivered in 2 sachets throughout the day with main meals
Experimental: behavioural lifestyle intervention; new educational program to change eating behaviour, provided through weekly sessions.	Behavioral: Lifestyle intervention; weekly educational sessions to improve individual's eating behaviour
Placebo Comparator: placebo dietary supplement; equicaloric daily maltodextrin	Dietary supplement: Placebo; equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood-oxygenation-level-dependent (BOLD) activity during food wanting	BOLD-acitvity will be measured using event-related echo-planar T2*-weighted magnetic resonance imaging (MRI) during food wanting task according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Wanting rating scores (on an 8-point likert scale) per stimulus will be added as covariates. In a parallel model, kcal of food stimuli will be added multiplied with wanting scores to model high caloric food wanting interaction. At the group level, we will assess the contrasts food > art and wanting modulation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbial alpha and beta diversity	Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples	6 months
fMRI BOLD activity memory performance	BOLD-acitvity will be measured using event-related echo-planar T2*-weighted magnetic resonance imaging (MRI) during food wanting and food memory recognition tasks according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation in encoding and recognition will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Correctly remembered and correctly rejected, as well as misses and false alarms will be modeled separately. In parallel models, similar and new items als well as wanting rating scores (on an 8-point likert scale) per stimulus and kcal of food stimuli multiplied with wanting scores will be added as covariates. At the group level, we will assess the contrasts correct > false and wanting modulation.	6 months
satiety	self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).	6 months
ghrelin	ghrelin pg/ml in blood	6 months
leptin	leptin ng/ml in blood	6 months
GLP-1	Glucagon-like peptide-1 (GLP-1) pg/ml in blood	6 months
PYY	peptide YY pg/ml in blood	6 months
insulin	insulin in blood uU/ml	6 months
HbA1c	hemoglycated globulin A1c in blood %	6 months
inflammatory markers	high sensitive C-reactive protein mg/l (and optionally tumor necrosis factor alpha and interleukin 6 in blood, pg/ml)	6 months
microbial metabolic markers in blood	short-chain fatty acids (SCFA), bile acids	6 months
body mass index	weight kg/height in m squared	6 months
waist hip ratio	waist (cm) to hip (cm) circumeference ratio	6 months
body fat	body fat % according to bioelectrical impedance analysis	6 months
food craving	assessed with the food craving questionnaire (Meule et al., 2012, German version).	6 months
executive attention performance	measured using the attention network task (ANT)	6 months

Collaborators and Investigators

• Sponsor: Max Planck Institute for Human Cognitive and Brain Sciences
• Collaborators: Universitätsklinikum Leipzig; DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation); Helmholtz-Zentrum für Umweltforschung - UFZ
• Investigators: Principal Investigator: Veronica Witte, PhD, Cognitive Neurology, University Medical Center Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: MIFOOD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share all data openly but anonymized on secured German servers of the institute after registration with ID.
• IPD Sharing Time Frame: after end of study for 5 years or longer
• IPD Sharing Access Criteria: Registration on a website, providing copy of ID
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No