Impact of Microbiome-changing Interventions on Food Decision-making

Overweight and Obesity Clinical Trial

— 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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353504
• Other study ID #: MIFOOD
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2022
• Source: Max Planck Institute for Human Cognitive and Brain Sciences
• Contact: Meghedi Vartanian, MSc
• Phone: +49(0)341/9940-951
• Email: mi-food[@]cbs.mpg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences	Leipzig

Sponsors (4)

Lead Sponsor	Collaborator
Max Planck Institute for Human Cognitive and Brain Sciences	DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation), Helmholtz-Zentrum für Umweltforschung - UFZ, Universitätsklinikum Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

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