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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Inulin
Lifestyle intervention
Placebo
Sponsored by
Max Planck Institute for Human Cognitive and Brain Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

prebiotic dietary supplement

behavioural lifestyle intervention

placebo dietary supplement

Arm Description

high-dose daily inulin

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

equicaloric daily maltodextrin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

microbial alpha and beta diversity
Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples
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.
satiety
self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).
ghrelin
ghrelin pg/ml in blood
leptin
leptin ng/ml in blood
GLP-1
Glucagon-like peptide-1 (GLP-1) pg/ml in blood
PYY
peptide YY pg/ml in blood
insulin
insulin in blood uU/ml
HbA1c
hemoglycated globulin A1c in blood %
inflammatory markers
high sensitive C-reactive protein mg/l (and optionally tumor necrosis factor alpha and interleukin 6 in blood, pg/ml)
microbial metabolic markers in blood
short-chain fatty acids (SCFA), bile acids
body mass index
weight kg/height in m squared
waist hip ratio
waist (cm) to hip (cm) circumeference ratio
body fat
body fat % according to bioelectrical impedance analysis
food craving
assessed with the food craving questionnaire (Meule et al., 2012, German version).
executive attention performance
measured using the attention network task (ANT)

Full Information

First Posted
March 23, 2022
Last Updated
April 26, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT05353504
Brief Title
Impact of Microbiome-changing Interventions on Food Decision-making
Acronym
MIFOOD
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"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prebiotic dietary supplement
Arm Type
Active Comparator
Arm Description
high-dose daily inulin
Arm Title
behavioural lifestyle intervention
Arm Type
Experimental
Arm Description
new educational program to change eating behaviour, provided through weekly sessions.
Arm Title
placebo dietary supplement
Arm Type
Placebo Comparator
Arm Description
equicaloric daily maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin
Intervention Description
28g/day delivered in 2 sachets throughout the day with main meals
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
weekly educational sessions to improve individual's eating behaviour
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals
Primary Outcome Measure Information:
Title
blood-oxygenation-level-dependent (BOLD) activity during food wanting
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
microbial alpha and beta diversity
Description
Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples
Time Frame
6 months
Title
fMRI BOLD activity memory performance
Description
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.
Time Frame
6 months
Title
satiety
Description
self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).
Time Frame
6 months
Title
ghrelin
Description
ghrelin pg/ml in blood
Time Frame
6 months
Title
leptin
Description
leptin ng/ml in blood
Time Frame
6 months
Title
GLP-1
Description
Glucagon-like peptide-1 (GLP-1) pg/ml in blood
Time Frame
6 months
Title
PYY
Description
peptide YY pg/ml in blood
Time Frame
6 months
Title
insulin
Description
insulin in blood uU/ml
Time Frame
6 months
Title
HbA1c
Description
hemoglycated globulin A1c in blood %
Time Frame
6 months
Title
inflammatory markers
Description
high sensitive C-reactive protein mg/l (and optionally tumor necrosis factor alpha and interleukin 6 in blood, pg/ml)
Time Frame
6 months
Title
microbial metabolic markers in blood
Description
short-chain fatty acids (SCFA), bile acids
Time Frame
6 months
Title
body mass index
Description
weight kg/height in m squared
Time Frame
6 months
Title
waist hip ratio
Description
waist (cm) to hip (cm) circumeference ratio
Time Frame
6 months
Title
body fat
Description
body fat % according to bioelectrical impedance analysis
Time Frame
6 months
Title
food craving
Description
assessed with the food craving questionnaire (Meule et al., 2012, German version).
Time Frame
6 months
Title
executive attention performance
Description
measured using the attention network task (ANT)
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
all genders, self-report
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghedi Vartanian, MSc
Phone
+49(0)341/9940-951
Email
mi-food@cbs.mpg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Witte, PhD
Organizational Affiliation
Cognitive Neurology, University Medical Center Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghedi Vartanian, Msc
Phone
+49(0)341/9940-954
Email
mi-food@cbs.mpg.de
First Name & Middle Initial & Last Name & Degree
Silke Friedrich
Phone
+49(0)341/9940-954
Email
mi-food@cbs.mpg.de
First Name & Middle Initial & Last Name & Degree
Veronica Witte, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Impact of Microbiome-changing Interventions on Food Decision-making

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