Not yet recruitingNAINTERVENTIONAL

Coffee Bioequivalence Trial

This research wants to find out if taking coffee in a tablet form has the same effects inside your body as drinking instant coffee. We'll also see how both coffee types compare to not having coffee at all when it comes to markers of your heart and liver health. This is an important step because coffee is thought to have benefits for diseases like heart conditions and liver problems. If coffee tablets work similarly to drinks, it could make it easier for people to take part in bigger studies in the future, helping us understand more about coffee's health effects and why they happen.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Reading

Enrolment target

Start

01 Jan 2025

Estimated completion

30 Dec 2025

Liver Functions Bioequivalence Cardiovascular Risk Cardiometabolic Risk Markers

What is this study about?

This study is a bit like a detective story, trying to understand how coffee affects our bodies. Researchers have noticed that people who drink a moderate amount of coffee (about 2-4 cups a day) seem to have a lower risk of certain diseases, especially those affecting the heart and liver. This sounds promising, but these observations don't fully prove that coffee is the direct cause of these benefits.

To find out more, scientists need to do more detailed studies. Imagine a big, important study coming in 2025 that will look closely at how coffee affects the risk of diseases like type 2 diabetes, heart disease, and liver problems. To make it easier for people to participate in that future study, the researchers are exploring if coffee can be given in a simple tablet form instead of always as a drink. This current study is designed to answer a key question for that future research: does coffee in a tablet act the same way in your body as coffee you drink?

So, this trial will carefully compare three things: instant coffee as a drink, coffee in a tablet, and a control (no coffee at all). By doing this, they hope to understand if the important parts of coffee get into your blood and urine in the same amounts whether you drink it or take a pill. They will also quietly check how each approach affects signs related to your heart and liver health. This information is crucial for planning the larger follow-up study and potentially making it much simpler for people to take part.

Key takeaways

This study compares coffee as a drink, a tablet, and no coffee at all.
It aims to see if coffee tablets have the same body effects as drinking coffee.
Researchers will also check short-term impacts on heart and liver health markers.
Participation involves three separate visits, each with an 8-hour and a 1-hour session.
You'll have blood tests, urine collection, and dietary recording.
The findings will help plan a larger study on coffee's long-term health benefits.

Who may be eligible?

To be considered for this study, you need to be a healthy man or a pre-menopausal woman with regular periods, aged between 18 and 45. Your Body Mass Index (BMI) should be between 18.5 and 30.

There are several reasons why you might not be able to join. For example, if you're sensitive to coffee or caffeine, or have allergies to common foods like gluten or lactose. You also can't be a current smoker or vaper, or have had certain health conditions in the past, including chronic diseases like cancer, high blood pressure, diabetes, heart disease, or liver or kidney problems. If you have anaemia or take any medications that affect blood pressure, inflammation, or blood thinning, you won't be eligible.

Other reasons for not being able to join include drinking more than 14 units of alcohol per week, taking any supplements (like vitamins or minerals), or having had significant weight loss recently (more than 3kg in the last 6 months). You also can't be pregnant, planning a pregnancy, breastfeeding, or participating in another medical study. Lastly, if you’ve donated blood in the last three months, you won't be able to take part.

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 45 years old?
Do you have a healthy weight (BMI 18.5-30)?
Are you generally healthy and don't have chronic conditions like diabetes or heart disease?
Are you free from coffee/caffeine sensitivity or food allergies to common foods?
Are you not currently smoking or vaping, and do you drink alcohol within recommended limits (no more than 14 units/week)?
Are you not pregnant, breastfeeding, or planning a pregnancy in the next 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic three separate times. Each visit is split into two parts: an eight-hour session on the first day and a short one-hour check-up the following morning.

During each of these three phases, you'll be given either coffee to drink, coffee in a tablet, or a coffee-free control. Which one you get will be decided randomly, but you'll get a different option each time. On the first day of each phase (the eight-hour visit), a small, thin tube (called a cannula) will be gently placed into a vein in your arm. This is so researchers can take regular blood samples without needing to prick you repeatedly. They will also do some basic health checks.

On the second day of each phase, you'll return for a quick visit. This will involve another blood sample, taken after you've fasted overnight, and more basic health checks. Additionally, you'll be asked to collect all your urine for 24 hours. Before each phase, you'll need to record everything you eat and drink for three days so they can understand your usual diet.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While this study won't offer a direct medical benefit to you personally, your participation is very valuable. The information gathered will help scientists better understand coffee's effects on health, which could lead to better health advice for many people in the future. As for risks, having blood samples taken can sometimes cause minor bruising or discomfort. The study is carefully designed to minimise risks, and you have the right to withdraw from 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.

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Verified postcode
Reading, United Kingdom

Common questions

What is 'bioequivalence'?

It means checking if two different ways of giving something (like coffee as a drink versus a tablet) have the same effect inside your body, reaching similar levels in your blood and urine.

Why are you looking at coffee in a tablet?

Scientists want to see if coffee in a pill is just as effective as a drink. If it is, it could make it much easier for people to take part in future large studies about coffee's health benefits.

Will I know if I'm getting coffee or the control?

No, this is a 'blinded' study, meaning you won't know which one you're receiving at each visit. This helps keep the results fair and unbiased.

How much blood will be taken?

On the initial 8-hour visit for each phase, blood samples will be taken regularly, totalling about 14 ml at the start, plus subsequent samples. For comparison, a typical blood donation is around 470 ml.

What are 'cardiometabolic risk markers'?

These are signs in your body, often measured in blood tests, that can show if you're at a higher risk of developing diseases like heart disease, stroke, or type 2 diabetes.

How to find out more

Charlotte E Mills, PhD

c.e.mills@reading.ac.uk 0118378 Official trial record

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