RecruitingNAINTERVENTIONAL

The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.

This research is investigating a natural supplement called 7-keto lithocholic acid (7-KLCA), which is inspired by the bile acids your body naturally produces. Bile acids help you digest fats and absorb important vitamins. We've recently learned they also play a big role in your gut health by affecting the types of bacteria living there. This study aims to find out if taking 7-KLCA can help increase beneficial gut bacteria, potentially improving your digestion and overall health. We're testing this in healthy volunteers to understand its effects on the gut's tiny inhabitants and chemical signals. If you're generally healthy, aged 18-65, and interested in contributing to our understanding of gut health, you might be able to take part.

At a glance

Status

Recruiting

Phase

Sponsor

University of Reading

Enrolment target

Start

06 Apr 2026

Estimated completion

31 Dec 2027

Healthy

What is this study about?

Your body naturally produces something called bile acids, which are crucial for breaking down fats in your diet and helping you absorb important vitamins and nutrients. Think of them as a natural detergent that helps mix oils and water in your gut. Recently, scientists have discovered that these bile acids also have a significant impact on the tiny organisms (bacteria and other microbes) that live in your gut, often called your gut microbiome. These gut microbes are incredibly important for your digestion and overall health.

When you eat, bile acids are released to help digest your food. Most of these bile acids are recycled, but a small amount travels to your colon where they interact with your gut bacteria. These bacteria then change the bile acids into new forms, which can have beneficial effects on your health. We are particularly interested in a specific bile acid called 7-keto lithocholic acid (7-KLCA) because early lab tests suggest it could help increase the growth of `'good'` bacteria in your gut, like Lactobacillus and Bifidobacterium, which are known to be helpful for health.

This study aims to give healthy volunteers a supplement (7-KLCA or a non-active powder) to see if taking it changes their gut bacteria in a positive way. By understanding how 7-KLCA affects the gut microbiome, we hope to learn more about how we might use such supplements in the future to improve digestion, support metabolism (how your body uses energy), and potentially even help prevent certain health problems. This research is about exploring the potential of natural compounds to boost your gut health.

Key takeaways

This study explores a natural supplement (7-KLCA) for gut health.
It aims to see if 7-KLCA can boost 'good' gut bacteria in healthy people.
Bile acids are essential for digestion and influence gut microbes.
Participation involves taking a supplement and providing samples (e.g., blood, stool).
The study seeks healthy volunteers aged 18-65, not on certain medications or diets.
Results could help us understand new ways to support gut health.

Who may be eligible?

To join this study, we're looking for healthy people generally between 18 and 65 years old. You should be in good physical and mental health and not have any known illnesses. It's important that you also haven't taken any probiotic or prebiotic supplements (like those found in certain yoghurts or health drinks) in the last month, and you shouldn't have any gut-related issues like irritable bowel syndrome (IBS) or food allergies.

There are some reasons why you wouldn't be able to take part. For example, if you're pregnant or breastfeeding, if you smoke, or if you're taking any daily prescribed medicines for a health condition. We also can't include people who follow very strict diets like vegan, keto, or Atkins diets, or those who have recently used antibiotics or laxatives. Basically, we need participants whose bodies are in a 'natural' and healthy state, without medical conditions or treatments that might interfere with the study's results.

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, without any ongoing medical conditions?
Are you between 18 and 65 years old?
Have you avoided probiotic or prebiotic supplements for the last 4 weeks?
Are you free from gut issues like IBS or food allergies?
Are you not taking any prescription medication for existing health conditions?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the 7-KLCA supplement or a non-active powder (called a placebo, like a sugar pill). You won't know which one you're taking, and neither will the researchers, to ensure the results are unbiased. During the study, you'll need to visit the study clinic for check-ups and to provide samples, such as stool or blood, so we can see how your gut bacteria and overall health are responding.

The study will involve regularly taking the supplement as instructed. You'll be asked to follow a normal, non-restrictive diet throughout the study, avoiding specific extreme diets. We'll provide detailed instructions for everything you need to do. The total duration of your involvement in the study will be explained to you in full before you agree to take part.

Potential risks and benefits

Taking part in this study could help us learn more about how certain supplements can affect gut health, which might lead to new ways to support wellbeing. While we don't expect major issues, as with any study, there could be some minor risks, like discomfort from giving samples. We'll tell you about any known risks before you decide to join. Your safety and wellbeing are our top priority. Remember, participating is entirely voluntary, 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, Harry Nursten Building, University of Reading, Whiteknights Campus, RG6 6UR
Verified postcode
Reading, United Kingdom· Recruiting

Common questions

What are bile acids, and why are they important?

Bile acids are natural substances in your body that help you digest fats and absorb nutrients from your food. They also play a role in your gut's health by interacting with the bacteria there.

What is the gut microbiome?

The gut microbiome is the collection of all the tiny living things, mostly bacteria, that live in your digestive system. They are very important for your digestion and overall health.

What is 7-keto lithocholic acid (7-KLCA)?

7-KLCA is a type of bile acid that we believe might encourage the growth of helpful bacteria in your gut. This study is testing to see if it works this way in people.

Will I know if I'm getting the active supplement or the non-active one?

No, you won't know if you're getting 7-KLCA or a non-active powder. This is done so that the results of the study are as fair and unbiased as possible.

Can I eat normally during the study?

Yes, you should continue with your usual, balanced diet. We'll let you know if there are any specific foods or drinks to avoid, but generally, extreme diets like vegan or keto are not allowed.

How to find out more

Abigail Basson, PhD

biomet-7@reading.ac.uk +44(0)7756872508 Official trial record

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