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

NCT07499414 | Recruiting

• 1 other identifier: BioMet-7
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

gut microbiome; metabolic health; 7-KLCA; bile acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in production of SCFA by the gut microbiota

  Baseline, Weeks 4, 12 and 16

• Blood markers of health

  Baseline, Weeks 4, 12 and 16

Study Arms (2)

7-KLCA

ACTIVE COMPARATOR

7-KLCA intervention (400mg, taken once daily, in tablet form)

Dietary Supplement: 7-KLCA

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin placebo (also in tablet form, taken once daily)

Dietary Supplement: Maltodextrin

Interventions

7-KLCA DIETARY_SUPPLEMENT

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.

7-KLCA

Maltodextrin DIETARY_SUPPLEMENT

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.

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Reading: lead
• ABC Farmaceutici S.p.A.: collaborator

Study Sites (1)

Hugh Sinclair Unit, Harry Nursten Building, University of Reading, Whiteknights Campus, RG6 6UR

Reading, United Kingdom

RECRUITING

MeSH Terms

Interventions

maltodextrin

Central Study Contacts

Abigail Basson, PhD

CONTACT

+44(0)7756872508; biomet-7@reading.ac.uk

Kimberly Watson, DPhil

CONTACT

+44(0)1183786640; biomet-7@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 30, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)