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

Max Planck Institute for Human Cognitive and Brain Sciences

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Behavioral: Lifestyle intervention; Dietary Supplement: Inulin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05353504

MIFOOD

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

prebiotic dietary supplement

Active Comparator group

Description:

high-dose daily inulin

Treatment:

Dietary Supplement: Inulin

behavioural lifestyle intervention

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle intervention

placebo dietary supplement

Placebo Comparator group

Description:

equicaloric daily maltodextrin

Treatment:

Dietary Supplement: Placebo