Impact of Microbiome-changing Interventions on Food Decision-making

NCT05353504 | Recruiting

• 1 other identifier: MIFOOD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• microbial alpha and beta diversity

  6 months

• fMRI BOLD activity memory performance

  6 months

• satiety

  6 months

• ghrelin

  6 months

• leptin

  6 months

Study Arms (3)

prebiotic dietary supplement

ACTIVE COMPARATOR

high-dose daily inulin

Dietary Supplement: Inulin

behavioural lifestyle intervention

EXPERIMENTAL

new educational program to change eating behaviour, provided through weekly sessions.

Behavioral: Lifestyle intervention

placebo dietary supplement

PLACEBO COMPARATOR

equicaloric daily maltodextrin

Dietary Supplement: Placebo

Interventions

Inulin DIETARY_SUPPLEMENT

28g/day delivered in 2 sachets throughout the day with main meals

prebiotic dietary supplement

Lifestyle intervention BEHAVIORAL

weekly educational sessions to improve individual's eating behaviour

behavioural lifestyle intervention

Placebo DIETARY_SUPPLEMENT

equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals

placebo dietary supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: all genders, self-report
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \>= 25 kg/m2 or WHR \>= 0.9/0.85 (m/d, f)
• no MRI contra-indication
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Max Planck Institute for Human Cognitive and Brain Sciences: lead
• Universitätsklinikum Leipzig: collaborator
• DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation): collaborator
• Helmholtz-Zentrum für Umweltforschung - UFZ: collaborator

Study Sites (1)

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

Leipzig, Germany

RECRUITING

Related Publications (1)

• Vartanian M, Endres KJ, Lee YT, Friedrich S, Meemken MT, Schamarek I, Rohde-Zimmermann K, Schurfeld R, Eisenberg L, Hilbert A, Beyer F, Stumvoll M, Sacher J, Villringer A, Christensen JF, Witte AV. Investigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol. BMC Nutr. 2025 Jan 13;11(1):8. doi: 10.1186/s40795-024-00971-6.

  PMID: 39806493 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Inulin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Veronica Witte, PhD

  Cognitive Neurology, University Medical Center Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghedi Vartanian, MSc

CONTACT

+49(0)341/9940-951; mi-food@cbs.mpg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: People will be randomly assigned to the three arms and blinded towards receipt of dietary fibre supplement or placebo supplement. However, behavioural lifestyle intervention arm cannot be blinded to participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 29, 2022
• Study Start: March 8, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: after end of study for 5 years or longer
• Access Criteria: Registration on a website, providing copy of ID

Locations

DE (1)