RecruitingNAINTERVENTIONAL

Impact of Microbiome-changing Interventions on Food Decision-making

This study aims to understand how changes in our gut bacteria affect how we decide what to eat, particularly for adults who are overweight or obese. Researchers will look at whether a special type of fibre (prebiotic) or a healthy lifestyle program can improve food choices. They also want to discover how these changes affect the bacteria in our gut and body chemistry. The study involves 90 adults and will last about 26 weeks. Participants will have brain scans, cognitive tests, and provide stool and blood samples. The goal is to find new ways to help people make healthier food decisions and manage their weight.

At a glance

Status

Recruiting

Phase

Sponsor

Max Planck Institute for Human Cognitive and Brain Sciences

Enrolment target

Start

08 Mar 2022

Estimated completion

01 Dec 2026

Overweight and Obesity

What is this study about?

This research is looking into a really interesting connection: how the tiny living things in our gut (called the microbiome) might influence the decisions we make about food. Specifically, they're focusing on adults who are overweight or have obesity. The main idea is to see if making certain changes, either to what we eat or how we live, can help us make better food choices.

The study will involve 90 people who are overweight or obese. Some participants will receive a special type of fibre, others will join a healthy lifestyle program with weekly educational sessions, and a third group will receive a starch supplement (which is a control to compare against). Over about 26 weeks, the researchers will carefully watch for any changes. They believe that by carefully looking at the gut bacteria and how our bodies process food, they can find out how these different approaches affect our eating behaviour.

Learning more about this 'gut-brain communication' could be really important. If we can understand which gut bacteria play a key role in how we eat, it might lead to new and improved ways to help people manage their weight and develop healthier eating habits in our modern society.

Key takeaways

The study explores how gut bacteria influence food choices in overweight adults.
It tests a special fibre or a healthy lifestyle program.
Participation involves brain scans, cognitive tests, and samples.
The study lasts about 26 weeks with regular check-ins.
Findings could lead to new ways to support healthy weight management.

Who may be eligible?

To be considered for this study, you generally need to be an adult between 18 and 60 years old. You would also need to have a Body Mass Index (BMI) of 25 or higher, or a waist-to-hip ratio that suggests you are overweight (specifically 0.9 or higher for men, and 0.85 or higher for women). It's also important that you are able to have an MRI scan safely and are happy to give your written permission to join the study.

However, some health conditions or situations would mean you cannot take part. For example, if you are a professional athlete, have had certain mental health conditions (like severe depression, substance abuse, eating disorders, or schizophrenia) in the last year, or have serious ongoing illnesses like type 1 diabetes, other long-term inflammation, or cancer, you wouldn't be able to join. If you've had weight-loss surgery in the past, or if you are pregnant or breastfeeding, you also wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Is your Body Mass Index (BMI) 25 or higher?
Have you *not* had severe mental health issues in the last year?
Do you *not* have type 1 diabetes or other serious long-term illnesses?
Are you *not* pregnant or breastfeeding?
Are you able to have an MRI scan safely?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of three groups at random. You might receive a special fibre supplement, join a weekly healthy lifestyle education program, or receive a starch supplement. The study will last for approximately 26 weeks, which is about six months. Before the study begins and again at the end, you will visit the research clinic. During these visits, you will have brain scans (MRI), complete some thinking and memory tests, and provide samples of your stool (poo) and blood. You'll also be asked to fill out questionnaires about your diet, lifestyle, and your body measurements throughout the study.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as gaining a better understanding of how diet and lifestyle changes might affect your food choices and gut health. While the interventions (special fibre or lifestyle program) are generally considered low-risk, there might be occasional mild side effects from supplements, or scans, or minor discomfort from blood draws. You will be fully informed about any known risks before you agree to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is a 'microbiome'?

It's the community of tiny living things, like bacteria, that live inside our bodies, especially in our gut.

What does 'food decision-making' mean?

It's about how our brains choose what to eat, when to eat, and how much to eat.

What is a 'prebiotic'?

A prebiotic is a type of fibre that helps healthy bacteria in your gut grow and thrive.

Will I know which group I'm in?

No, this is a 'blinded' study, so you won't know if you're getting the fibre, lifestyle program, or control supplement until the study is over.

What is an MRI scan?

An MRI is a safe way to take detailed pictures of your brain using magnets and radio waves, without using X-rays.

How to find out more

Meghedi Vartanian, MSc

mi-food@cbs.mpg.de +49(0)341/9940-951 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.