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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Healthy

In brief

In humans and most mammals, bile acids play a role in the metabolism of glucose and the transport and absorption of lipids (such as cholesterol and triglycerides), vitamins, and nutrients by allowing for emulsification (mixing) and absorption of fatty molecules that are consumed. More recently, bile acids have been discovered to influence the composition and quantity of the microorganisms in the gut microbiome. Bile acids also act as signalling molecules (like hormones) in the body, regulating important metabolic pathways and digestion. While the majority of bile acids are recycled back to the liver, a small proportion of these bile acids enter the colon and interact with the gut microbiota. Primary bile acids, synthesized in the liver, are essential for the absorption of fat- and fat-soluble vitamins, as part of the digestive process. These primary bile acids are converted to secondary bile acids by gut bacteria, which have been shown to have benefits to health. This provides the rationale for exploring the use of a bile acid, in this case 7-keto lithocholic acid (7-KLCA), as a beneficial modulator of the gut microbiome, to help regulate metabolic and potentially other disease pathways.

Key facts

Study ID

NCT07499414

Run by

University of Reading

People needed

40

Starts

2026-04-06

Expected to finish

2027-12-31

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Volunteer is healthy (good physical and mental condition, disease-free, with haemoglobin levels between 138 - 172 g/L for male and between 121 and 151 g/L for female) at the time of pre-examination
• Volunteer is aged ≥ 18 to ≤ 65 years for the duration of the study
• Volunteer is able and willing to comply with the study instructions
• Volunteer is suitable for participation in the study according to the investigator/study personnel
• Volunteer is able to give informed consent
• Volunteer must be following a non-restrictive diet according to the investigator/study personnel (no vegan, keto or fasting diets)
• Volunteer has not consumed pro- or prebiotic supplements or food products for a minimum of 4 weeks prior to starting the intervention.
• Volunteer has no gastrointestinal disorders

You may not qualify if…

• No command of any local language
• Gastrointestinal disorders including IBS, IBD or other conditions that might affect the gut environment
• Food allergies or intolerances
• Using drugs (e.g. antibiotics) influencing gastrointestinal function (12 weeks before intervention)
• Use of laxatives
• Clinically significant diabetes (plasma glucose test, fasting blood glucose > 6.5 mmol/l (120 mg/dL)
• Volunteers currently involved or will be involved in another clinical/ food study for the duration of this study
• History of drug (pharmaceutical or recreational) or alcohol abuse.
• If participants are pregnant or are lactating
• Regular intake of probiotic or prebiotic supplements
• Smoker
• Those who follow extreme diets (Keto-diet, Atkins diet, vegan)
• Those taking prescribed medication for existing health condition(s)
• Those with a pacemaker

Where it is running

• Hugh Sinclair Unit, Harry Nursten Building, University of Reading, Whiteknights Campus, RG6 6UR — Reading, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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