Impact of Microbiome-changing Interventions on Food Decision-making

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMax Planck Institute for Human Cognitive and Brain Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

BMI >= 25 kg/m2 or WHR >= 0.9/0.85 (m/d, f)

no MRI contra-indication

written informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inulin

    Dietary supplement

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

  • Lifestyle intervention

    Behavioral

    weekly educational sessions to improve individual's eating behaviour

  • Placebo

    Dietary supplement

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: prebiotic dietary supplementActive comparator 1 intervention
Group B: behavioural lifestyle interventionExperimental treatment 1 intervention
Group C: placebo dietary supplementPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

microbial alpha and beta diversity

Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples

Time frame
6 months
2

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.

Time frame
6 months
3

satiety

self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).

Time frame
6 months
4

ghrelin

ghrelin pg/ml in blood

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Max Planck Institute for Human Cognitive and Brain Sciences

Lead sponsor

Universitätsklinikum Leipzig

Collaborator

DFG - Deutsche Forschungs Gemeinschaft (German Research Foundation)

Collaborator

Helmholtz-Zentrum für Umweltforschung - UFZ

Collaborator