Not yet recruitingNAINTERVENTIONAL

Investigating the Acute and Chronic Effects of a Supplement Containing Caffeine, Vitamins, Minerals and Botanical Extracts on Cognition, Sleep and Wellbeing, in Healthy Volunteers

Researchers are studying a supplement containing caffeine, vitamins, minerals, and plant extracts. The aim is to understand its short-term and long-term effects on how people think and concentrate (cognitive function), their sleep, and their general mood and wellbeing. Healthy volunteers aged 18 to 75 will participate. Each person will try both the real supplement and a dummy pill (placebo) at different times, without knowing which one they are taking. We want to see if this supplement can safely improve mental sharpness, sleep patterns, and overall feelings of health.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Northumbria University

Enrolment target

Start

24 Feb 2025

Estimated completion

19 Dec 2025

Caffeine Sleep Cognitive Function Wellbeing Mood

What is this study about?

This research study is looking at whether a special supplement can help improve how your brain works, how well you sleep, and your general sense of wellbeing. This supplement contains a mix of caffeine (like in coffee, but a controlled amount), vitamins, minerals, and natural plant extracts. The researchers want to know if taking this supplement for a short time or over a longer period has any noticeable effects on healthy adults.

To make sure the results are fair and accurate, the study is designed very carefully. Participants won't know if they are taking the actual supplement or a 'dummy' pill (called a placebo) that looks the same but contains harmless ingredients. Also, the researchers won't know either. This helps prevent anyone's expectations from influencing the results. Each person will get to try both the real supplement and the dummy pill at different times during the study. This way, the researchers can compare the effects of the supplement against doing nothing special.

Understanding how different ingredients, especially natural ones, can affect our bodies is important. If this supplement proves to be helpful, it could offer a new way for healthy people to potentially support their brain function, get better sleep, and boost their overall mood. However, it's crucial to remember that this is a research study to find out more, not a recommendation for anyone to take this supplement.

Key takeaways

Study investigates a supplement's effects on brain, sleep, and mood.
Participants will try both the active supplement and a dummy pill.
Caffeine, vitamins, minerals, and plant extracts are in the supplement.
Aimed at healthy adults aged 18-75 in the UK.
Involves home use of the supplement and 5 visits to a research centre.

Who may be eligible?

This study is looking for healthy adults between 18 and 75 years old. You should feel that you are generally in good health and can speak English fluently.

There are some reasons why you might not be able to join. For example, if you already drink either very little or a lot of caffeine each day (outside specific limits), or if you have certain medical conditions or take particular prescription medicines. Conditions like uncontrolled high blood pressure, being pregnant or trying to get pregnant, or having certain brain conditions would also mean you can't take part. Your body mass index (BMI) also needs to be within a certain range.

Before you start, the research team will ask you some questions about your health and measure your blood pressure. If you have a long-term condition like a controlled thyroid issue, hay fever, high cholesterol, or reflux, you might still be able to join, so it's a good idea to discuss your specific situation with the research team.

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 generally healthy?
Are you between 18 and 75 years old?
Do you speak English fluently?
Do you consume a moderate amount of caffeine daily (not too little, not too much)?
Are you not pregnant, trying to get pregnant, or breastfeeding?
Do you not have uncontrolled high blood pressure or certain neurological conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a phone or video call to check if you're suitable. Then, you'll visit the research centre five times. The first visit will be for training on tasks and checking your measurements like height and weight. For the next four visits, you'll come to the centre, making sure you haven't had alcohol in the last 24 hours, or certain medications. You'll stick to your usual breakfast and caffeine routine before coming in. You'll complete computer tasks, online tests, and fill out questionnaires and a sleep diary.

During the study, you will take either the active supplement or a dummy pill each day for 29 days. After that, you'll switch to the other one for another 29 days. You'll get these to take home. Each day, you'll need to record when you take your treatment in a diary. You'll bring this diary, along with any unused supplements, to your follow-up visits at the research centre. The whole study will involve these regular doses, home diaries, and centre visits.

Potential risks and benefits

Taking part in this study could offer you a better understanding of how your body reacts to supplements, and you'll be contributing to scientific knowledge that might help others in the future. The potential benefits are that the supplement might improve your thinking skills, sleep, or mood, though this is what the study aims to find out. There are always potential risks with taking any new supplement, even if they contain common ingredients. These could include side effects from the caffeine or other components, though the dose is controlled. You will be monitored, and you are free to stop taking part at any time without giving a reason, which will not affect your usual medical care.

Locations (1)

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

Brain Performance and Nutrition Research Centre- Northumbria University
Verified postcode
Newcastle upon Tyne, United Kingdom

Common questions

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real supplement but doesn't contain any active ingredients. It helps researchers compare the effects of the actual supplement.

Will I know if I'm taking the real supplement or the placebo?

No, neither you nor the researchers will know whether you're taking the real supplement or the placebo. This is called 'double-blind' and makes the study results more reliable.

How much caffeine is in the supplement?

The active supplement contains 120mg of caffeine, which is about the same as a medium cup of instant coffee.

How long will I need to be in the study?

You will be in the study for two periods of 29 days each, taking one treatment then the other. This means about two months in total, plus initial screening and training visits.

Do I need to change my diet or lifestyle during the study?

You'll be asked to keep your normal routine regarding breakfast and caffeine before your testing visits. The main restrictions are avoiding alcohol, certain over-the-counter medications, and antihistamines before visits.

How to find out more

Emma L Wightman, PhD

emma.l.wightman@northumbria.ac.uk 0191 243 7253 Official trial record

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