Effects of 7-keto lithocholic acid (7-KLCA) on the gut microbiome and metabolic risk factors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls healthy adults aged 18–65 who will receive oral 7-KLCA or a maltodextrin comparator and be followed over the treatment period. Stool samples and blood tests will be collected before and after the intervention to measure changes in gut microbial composition and markers of metabolic health such as lipids and glucose. Participants must avoid pro- or prebiotic supplements for at least four weeks prior and follow a non-restrictive diet during the study. The trial builds on in vitro and preclinical data showing 7-KLCA is metabolized to UDCA and can promote beneficial bacteria, testing whether those effects occur in humans.

Why it matters

Who can join: the full rules

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

Where it's running

• Hugh Sinclair Unit, Harry Nursten Building, University of Reading, Whiteknights Campus, RG6 6UR
  Reading, United Kingdom Recruiting

Study contacts

• Study coordinator: Abigail Basson, PhD
• Email: biomet-7@reading.ac.uk
• Phone: +44(0)7756872508

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.