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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: 7-KLCA; Dietary supplement: Maltodextrin

Detailed Description

Bile acids are small, naturally occurring molecules that play a vital role in the metabolism of glucose and lipids. Bile acids are classified as primary or secondary. Primary bile acids are made from cholesterol in the liver, where they form bile salts and are transported into the gall bladder before finally being secreted into the stomach, as part of the digestive process. ~95% of bile acids are recycled back to the liver, but a small proportion enters the colon and interacts with our gut microbiome. In the gut, these primary bile acids are converted to secondary bile acids (by our gut bacteria), and act as secondary signalling molecules that can affect health. Recent discoveries show that bile acids directly affect the gut microbiome. In fact, ursodeoxycholic acid (UDCA), a secondary bile acid, has a long history in medicine. Though currently used to treat liver diseases, treatment with UDCA has been found to increase the beneficial bacteria Faecalibacterium prausnitzii and reduce levels of hydrogen- and methane-producing bacteria in the gut. Therefore, there is potential to use UDCA (and UDCA-like molecules) as a prebiotic-like molecule that can be used by our gut microorganisms to promote beneficial bacteria in the gut and lead to a health benefit.

The bile acid 7-keto lithocholic acid (7-KLCA) is metabolised in the gut to produce UDCA. Using our in vitro fermentation models, UDCA and 7-KLCA were evaluated and found to increase the incidence of the beneficial microorganisms: Lactobacillus, Eubacterium rectale and Bifidobacterium spp. Changes in downstream bacterial metabolites and increases in short chain fatty acids also were observed. Our in vitro fermentation results, coupled with our in vitro cell culture studies, suggest there may be additional mechanisms by which UDCA and UDCA-like molecules exert their beneficial effects.

This study aims to assess in vivo, via a human intervention study, the prebiotic potential of 7-KLCA, as a bile acid supplement, and how microbial changes in the gut can improve biomarkers, indicative of beneficial metabolic and microbiome function and reduce risk factors of disease. In preparation for this study, 7-KLCA has undergone toxicology, absorption, and bioavailability studies to ensure it is safe for human consumption. Blood faecal and urine samples will be obtained at key points in the study, to assess microbial changes (bacterial count and composition, as well as metabolite profiling analysis; fatty acid, bile acid and lipids) and monitor key biomarkers (blood glucose and cholesterol, and indicators of inflammation and immune response), to address our primary and secondary research questions.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail Basson, PhD; Phone Number: +44(0)7756872508; Email: biomet-7@reading.ac.uk
• Study Contact Backup: Name: Kimberly Watson, DPhil; Phone Number: +44(0)1183786640; Email: biomet-7@reading.ac.uk

Study Locations

• United Kingdom
  • Reading, United Kingdom
    • Recruiting
    • Hugh Sinclair Unit, Harry Nursten Building, University of Reading, Whiteknights Campus, RG6 6UR
    • Contact: Abigail Basson, PhD; Phone Number: +44(0)7756872508; Email: biomet-7@reading.ac.uk
    • Contact: Kimberly Watson, DPhil; Phone Number: +44(0)1183786640; Email: biomet-7@reading.ac.uk
    • Principal Investigator: Kimberly Watson, DPhil
    • Sub-Investigator: Abigail Basson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 7-KLCA; 7-KLCA intervention (400mg, taken once daily, in tablet form)	Dietary supplement: 7-KLCA; This study will be conducted as a 16 week duration parallel study. The trial will last for 112 days (16 weeks, includes a 1 month washout period and a follow up study visit to assess lasting effects) maximum, with participants assigned the intervention (400mg, taken once daily, 7-KLCA in tablet form) or maltodextrin placebo (also in matched tablet form) for 84 days.
Placebo Comparator: Maltodextrin; Maltodextrin placebo (also in tablet form, taken once daily)	Dietary supplement: Maltodextrin; This study will be conducted as a 16 week duration parallel study. The trial will last for 112 days (16 weeks, includes a 1 month washout period and a follow up study visit to assess lasting effects) maximum, with participants assigned the intervention (400mg, taken once daily, 7-KLCA in tablet form) or maltodextrin placebo (also in matched tablet form) for 84 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiome Composition	Changes in microbial composition in stool will be measured by Flow-FISH to directly assess the benefits of 7-KLCA on modulating the gut microbiome (baseline, Weeks 4, 12, 16). 16s sequencing will be used to assess response to 7-KLCA before and after intervention (baseline and Week 12).	Baseline, Weeks 4, 12 and 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in production of SCFA by the gut microbiota	Gas chromatography will be used to analyse changes in SCFA content in stool to assess the activity of the gut microbiota as a result of 7-KLCA intervention.	Baseline, Weeks 4, 12 and 16
Blood markers of health	Fasting blood glucose, Hb1Ac (baseline and Week 12), blood lipids (total cholesterol, HDL, LDL, triglycerides), liver function (ALT, AST), kidney function (eGFR, creatnine), inflammatory markers (CRP, ESR) and immune markers (TNF-alpha, IL-6) will be measured to assess the benefits of 7-KLCA, which may help reduce the risk of developing disease.	Baseline, Weeks 4, 12 and 16

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: ABC Farmaceutici S.p.A.

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2026
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: gut microbiome; metabolic health; bile acid; 7-KLCA
• Additional Relevant MeSH Terms: maltodextrin
• Other Study ID Numbers: BioMet-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No