Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT05353504

Impact of Microbiome-changing Interventions on Food Decision-making

Led by Max Planck Institute for Human Cognitive and Brain Sciences · Updated on 2022-04-29

90

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

Sponsors

M

Max Planck Institute for Human Cognitive and Brain Sciences

Lead Sponsor

U

Universitätsklinikum Leipzig

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Impact of Microbiome-changing Interventions on Food Decision-making

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI of 25 kg/m2 or higher or waist-to-hip ratio of 0.9 or higher for males, 0.85 or higher for females
  • No contraindications for MRI scans
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Professional athletes
  • Clinically relevant psychiatric diseases within the last 12 months, including depression, substance abuse, eating disorders, or schizophrenia
  • Any chronic inflammatory or malignant diseases
  • Type 1 diabetes
  • Previous bariatric or gastric surgery
  • Pregnancy or breastfeeding

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Trial Site Locations

Total: 1 location

1

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

Leipzig, Germany

Actively Recruiting

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Research Team

M

Meghedi Vartanian, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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