Active not recruitingNAINTERVENTIONAL

Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress

Researchers are investigating if special dietary fibres, called prebiotics, can help healthy adults who report having poor sleep. The study will look at how taking prebiotics for 56 days affects sleep quality, the healthy bacteria in your gut (your gut microbiome), your thinking skills, your body's immune system, and your stress levels. Participants will receive one of three different prebiotic mixtures or a placebo (a dummy pill with no active ingredient). This is a 'randomised, double-blind, controlled trial,' meaning people are put into groups by chance, and neither they nor the researchers will know who is getting which treatment until the study ends. This helps ensure fair and accurate results.

At a glance

Status

Active not recruiting

Phase

Sponsor

Northumbria University

Enrolment target

Start

03 Mar 2022

Estimated completion

01 Dec 2026

Sleep

What is this study about?

This research wants to understand if special plant fibres, called prebiotics, can make a difference for people who otherwise feel healthy but often don't get good sleep. Prebiotics are like food for the good bacteria in your gut, and scientists are finding out that these tiny gut bacteria can have a big impact on many parts of our health, including how we sleep, think, and even how stressed we feel.

The study will look at several important areas. First, it will check if prebiotics can improve your sleep. It will also explore changes in your gut bacteria, which is known as your 'gut microbiome.' On top of that, researchers will assess if prebiotics affect your thinking abilities, how well your immune system works to fight off illness, and your overall stress levels.

By comparing different types of prebiotics to a placebo (a treatment that looks the same but has no active ingredient), the researchers hope to learn if these fibres genuinely help people sleep better and improve other aspects of their health. The aim is to find safe and natural ways to support health for those experiencing poor sleep.

Key takeaways

Looks at how prebiotics affect sleep, gut health, thinking, immune system, and stress.
For healthy adults who feel they have poor sleep.
Compares different prebiotics to a dummy pill (placebo).
Study lasts for 56 days (about 8 weeks).
Neither participants nor researchers know who gets what.
Aims to find natural ways to support health and sleep.

Who may be eligible?

This study is looking for healthy adults between 25 and 60 years old who feel they don't sleep well. You need to have a fairly regular sleep schedule, usually going to bed between 9 pm and 1 am and waking up between 6 am and 10 am at least five nights a week. You also need to speak English fluently and score a certain amount on a sleep questionnaire, which helps officially identify you as a 'poor sleeper'.

There are several reasons why you might not be able to join. For example, if you have a diagnosed sleep disorder like sleep apnoea or severe insomnia, or if you take medicines that affect your sleep or brain, you won't be eligible. People who have had seizures, epilepsy, or who do shift work (or have done so recently) also cannot participate. You also can't be taking any other prebiotic or probiotic supplements within the last eight weeks. The study also cannot include pregnant or breastfeeding individuals, anyone with serious mental health issues, or those who misuse alcohol or drugs, or smoke.

It's important that you won't be travelling a lot across different time zones or staying away from your usual home much during the study. If you've had a recent infection or taken antibiotics in the last three months, these might also affect your eligibility.

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 25 and 60 years old?
Do you generally feel healthy but often struggle with poor sleep?
Do you have a fairly regular sleep schedule (not a shift worker)?
Have you avoided other prebiotics or probiotics for the last 8 weeks?
Do you not have a diagnosed sleep disorder or take medicines that severely affect sleep?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be asked to take one of three different prebiotic mixtures or a placebo (dummy pill) every day for 56 days (about eight weeks). You and the researchers won't know which one you're taking until the end of the study.

Throughout the study, you'll need to complete various assessments. These will look at your sleep quality, gut health (likely involving stool samples), your thinking skills through simple tests, your immune markers (which might involve blood or saliva samples), and your stress levels. You'll also be asked to keep a stable sleep schedule throughout the trial and avoid certain supplements.

The total duration of your active involvement in the study will be around eight weeks of taking the product and completing assessments, plus initial screening visits and a follow-up. You'll be given clear instructions on how to take the daily intervention and how often you'll need to complete questionnaires or provide samples.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as a possible improvement in your sleep, gut health, thinking abilities, immune function, or stress levels, depending on which intervention you receive. However, some people might experience mild side effects from the prebiotics, similar to those you might get from increasing fibre in your diet, such as bloating or gas. There's also the chance that the intervention won't have any effect for you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care now or in the future.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northumbria Sleep Research, Northumbria University
Verified postcode
Newcastle, United Kingdom
Northumbria University
Verified postcode
Newcastle, United Kingdom

Common questions

What is a prebiotic?

Prebiotics are special plant fibres that feed the good bacteria in your gut, helping them to grow and thrive.

What is a placebo?

A placebo is a dummy pill or treatment that looks exactly like the real one but has no active ingredients. It helps researchers fairly compare results.

Will I know if I'm taking a prebiotic or a placebo?

No, neither you nor the researchers will know who is taking which product until the study is finished. This is called 'double-blind'.

How long will I need to be in the study?

If you join, you will be taking the study product for 56 days (about 8 weeks), plus some time for initial checks and follow-up.

Can I still take my regular medicines if I join?

This depends on the specific medicines. Medicines that affect sleep or the brain might mean you can't join. You would discuss this with the study team.