Not yet recruitingNAINTERVENTIONAL

Evaluating the Effects of Nutritional Interventions on Sleep, the Gut Microbiome, Cognition, and Stress.

This research study aims to understand how special food supplements might help people who struggle with sleep. We're interested in whether these supplements can improve sleep, affect the bacteria in your gut (your 'gut microbiome'), boost your thinking skills, and reduce stress levels. If you join, you'll be given one of two active supplements or an inactive dummy pill (a 'placebo') to take every day for 28 days. Neither you nor the researchers will know which one you're taking. Throughout the study, we'll check your sleep quality, look at your gut bacteria, test your memory and focus, and ask about your mood. We want to see if these supplements can make a real difference in how you feel and function.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Northumbria University

Enrolment target

Start

01 May 2026

Estimated completion

01 Dec 2026

Stress Sleep Cognition Nutrition Microbiome

What is this study about?

This study is for adults who often don't get good sleep. We want to find out if certain food supplements can help improve sleep and other important areas of health.

We know that good sleep is super important for our overall well-being. But did you know that the health of the bacteria in your gut, your ability to think clearly, and your stress levels can all be connected to how well you sleep? This study will look at all these connections. We're testing two different active supplements, alongside a dummy pill, to see if they can make a positive change.

The goal is to learn more about how nutrition can play a role in improving sleep quality, supporting a healthy gut, sharpening our thinking abilities, and helping us manage stress. This kind of research helps us understand better ways to support health without always relying on traditional medicines.

Key takeaways

Tests how supplements affect sleep quality, gut health, thinking, and stress.
Participants will take one of two active supplements or a dummy pill for 28 days.
Neither you nor the researchers will know which pill you are taking.
Involves phone calls, university visits, sleep tracking, and providing a stool sample.
Aims to help us understand nutrition's role in improving overall well-being.

Who may be eligible?

This study is looking for volunteers between 25 and 65 years old. You should consider yourself to be in good health and be able to speak English well. Importantly, you must also feel like you are a 'poor sleeper', meaning you often don't get refreshing sleep, and your sleep quality score needs to be above a certain level.

There are several reasons why someone might not be able to join. For example, if you or someone in your household is already in the study, or if you have a diagnosed sleep disorder like sleep apnea or restless legs syndrome. We also can't include people who work night shifts, have traveled across different time zones recently, or are taking certain medications or nutritional supplements. If you're pregnant, trying to get pregnant, or breastfeeding, you won't be able to participate. We'll also check for recent infections, antibiotic use, and certain mood problems.

Don't worry if all this sounds a bit much – the research team will carefully go through everything with you to make sure it's safe and right for you to join.

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 65 years old?
Do you generally feel healthy?
Do you often find it hard to get good, refreshing sleep?
Are you currently not taking any other nutritional supplements?
Do you not work night shifts or have lately?
Are you not pregnant, trying to get pregnant, or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you're interested, you'll first have a phone call with a researcher. They'll explain the study in more detail, ask you some questions, and get your permission to continue via an online form. They'll check if you meet the initial requirements and might conduct a short sleep disorder check over the phone. If needed, you might have another phone call with a sleep expert.

If you're suitable, you'll then visit Northumbria University for an enrollment session. Here, you'll sign some final paperwork and learn all about the study procedures. Over the next seven nights, you'll track your sleep using a diary and provide an initial stool sample at a drop-off point. After this, you'll start taking your assigned supplement or dummy pill for 28 days. Throughout this time, you'll continue to assess your sleep. At the end of the 28 days, you'll have more assessments, including checking your sleep, gut bacteria, thinking skills, and mood again. The total duration of the study, from your first visit to the final assessments, will be just over a month.

Potential risks and benefits

Participating in any study has potential benefits and risks. You might not directly benefit from this study, as there's a chance you could receive the dummy pill, or the supplements might not work for you. However, the information we gain could help future patients with similar struggles. There are very few known risks with the type of supplements being tested. You might experience minor side effects, similar to what you might feel with any food supplement, but these are generally mild. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Northumbria University- Northumbria Sleep center and NUTRAN
Verified postcode
Newcastle upon Tyne, United Kingdom

Common questions

What kind of supplements are being tested?

The study is looking at two special food supplements designed to help with sleep, gut health, and stress. There's also a dummy pill (placebo) with no active ingredients.

Will I know if I'm getting the real supplement or the dummy pill?

No, neither you nor the research team will know if you're taking the active supplement or the dummy pill. This is called a 'double-blind' study.

How long will I be taking part in the study?

You'll be taking a supplement or dummy pill for 28 days, and the whole study, including initial checks and final tests, will take a bit over a month.

What will I have to do during the study?

You'll have phone calls, visit Northumbria University, track your sleep, provide a stool sample, and take a daily supplement. You'll also do some tests on your thinking skills and mood.

What if I get sick or change my mind?

You can leave the study at any time, for any reason, without needing to explain why, and it won't affect your regular medical care.

How to find out more

Pamela Alfonso-Miller, MD

pam.alfonso-miller@northumbria.ac.uk +44 01912274149 Official trial record

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