RecruitingNAINTERVENTIONAL

Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation

This 12-week study is testing if a daily probiotic supplement, called Lab4P, can improve brain function and overall health in overweight young adults aged 18-40. These participants have slightly high blood sugar, also known as prediabetes. Researchers will give either the probiotic or a dummy pill (placebo) to 70 people. They will then check for changes in memory, thinking speed, and how well people can focus. They will also measure blood sugar, cholesterol, body weight, and signs of inflammation. The study aims to understand if this probiotic is safe and helpful for improving both brain health and how the body handles sugar.

At a glance

Status

Recruiting

Phase

Sponsor

Leeds Beckett University

Enrolment target

Start

15 Aug 2025

Estimated completion

20 Aug 2026

Impaired Glucose Regulation Impaired Glucose Tolerance (Prediabetes)Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)Overweight (BMI > 25)Cognitive Dysfunction Neurovascular Coupling Mechanism and Cognitive Function

What is this study about?

You know how important it is to keep your blood sugar balanced for good health. Sometimes, especially when carrying extra weight, young adults can start to have blood sugar levels that are a bit higher than normal, even if they don't have diabetes yet. This is often called prediabetes. While it might not feel like a big deal at first, these small changes in blood sugar can sometimes affect how your brain works, including your memory and ability to focus.

Researchers are seeing that even slightly raised blood sugar levels might be linked to changes in the brain, which could affect how clearly you think. This study aims to explore if a specific type of 'good bacteria' supplement, called probiotics, could help. Probiotics are known to affect how our bodies handle sugar and can reduce inflammation, which is a key part of many health problems. By looking at how the brain and body respond to this probiotic, scientists hope to find new ways to help young adults stay healthy.

This study is important because it focuses on preventing future health issues. If a simple probiotic can help improve both brain function and how the body deals with sugar in overweight young adults with prediabetes, it could offer a straightforward way to support long-term health without needing medicines right away. It's about understanding how our gut health might be connected to our brain health and overall well-being.

Key takeaways

This study investigates if probiotics can help brain function and blood sugar in overweight young adults.
It's for people aged 18-40 who have slightly high blood sugar (prediabetes).
Participation involves taking a daily capsule for 12 weeks and attending clinic visits.
Researchers will check memory, thinking skills, blood sugar, and overall health.
The study aims to find new, non-medicinal ways to improve health for this group.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for volunteers who are between 18 and 40 years old. You should be considered overweight, which means your Body Mass Index (BMI) is between 25.0 and 29.9. You also need to be generally healthy and not have any diagnosed sleep problems. Crucially, you must have slightly high blood sugar (prediabetes), but not full-blown diabetes.

There are some reasons why you wouldn't be able to join. For example, if you have any type of diabetes, if you've had major surgery recently, or if you're taking medicines that affect your blood sugar or currently taking other probiotics. Women who are pregnant or trying to get pregnant cannot participate. Also, if you've recently worked night shifts, you wouldn't be eligible.

Quick self-check

Are you between 18 and 40 years old?
Is your BMI (Body Mass Index) between 25.0 and 29.9 (which is considered overweight)?
Have you been told you have slightly high blood sugar, or 'prediabetes'?
Are you generally healthy, without diagnosed diabetes or major sleep disorders?
Are you not currently pregnant or trying to conceive?
Are you not taking medications that affect blood sugar or other probiotics?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, it will last for 12 weeks. During this time, you'll be asked to take a daily capsule – either the probiotic or a dummy pill. You won't know which one you're taking, and neither will the study team. You'll need to visit the study clinic several times for different tests. These may include blood tests (which might require you to fast beforehand), tests to check your memory and thinking speed, and measurements of your body. We'll also collect samples to look at the bacteria in your gut. All procedures will be clearly explained, and you'll have doctors and nurses available to answer any questions. You can stop participating at any time.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as contributing to our understanding of gut health, brain function, and blood sugar control. You might also receive detailed health assessments. However, there's no guarantee that you will personally benefit from taking the probiotic; you might receive the dummy pill. Potential risks are generally low for supplements like probiotics, but like any study, there could be mild side effects, which will be monitored closely. Remember, your participation is voluntary, and you are free to withdraw from the study at any time without giving a reason, and it won't affect any of your usual medical care.

Locations (1)

Leeds Beckett University
Leeds, United Kingdom· Recruiting

Common questions

What is 'prediabetes'?

Prediabetes means your blood sugar levels are higher than normal but not yet high enough to be diagnosed as type 2 diabetes. It's a warning sign that you might be at risk for diabetes later on.

What is a 'probiotic'?

Probiotics are live bacteria and yeasts that are good for your health, especially your digestive system. They are often called 'good' bacteria.

What does 'double-blind, placebo-controlled' mean?

It means that neither you nor the study doctors will know whether you're receiving the actual probiotic or a dummy pill (placebo). This helps make the study results fair and unbiased.

Will I know if I was on the probiotic or the placebo after the study?

This may vary by study, but typically, after the study is completed and the results are analysed, participants can sometimes request to know which group they were in.

What does a 'cognitive performance' test involve?

These are usually simple computer-based or paper-and-pencil tasks that measure things like your memory, attention, reaction speed, and problem-solving skills.

How to find out more

Lewis F Hepburn

l.hepburn3449@student.leedsbeckett.ac.uk +447541333140 Official trial record

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