Clinical trial

Impact of Microbiome-changing Interventions on Food Decision-making

Recruiting now · Not applicable · 1 countries · Registry ID NCT05353504

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight and Obesity

Full registry 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

Treatments and study arms

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

Primary outcomes

blood-oxygenation-level-dependent (BOLD) activity during food wanting6 months

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.

Study locations

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Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences🇩🇪 Leipzig, Germany

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Meghedi Vartanian, MscContact

Email · Call +49(0)341/9940-954

Silke FriedrichContact

Email · Call +49(0)341/9940-954

Veronica Witte, PhDPrincipal Investigator