Effects of 7-keto lithocholic acid (7-KLCA) on the gut microbiome and metabolic risk factors.
The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.
We will test whether taking the bile acid supplement 7-keto lithocholic acid (7-KLCA) changes the gut microbiome and metabolic risk markers in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Reading Academic / other |
| Locations | 1 site (Reading) |
| Trial ID | NCT07499414 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Healthy adults aged 18–65 without gastrointestinal disorders, not taking pro- or prebiotic supplements, following a non-restrictive diet, and meeting hemoglobin and consent requirements.
Not a fit: People with gastrointestinal disorders (such as IBS or IBD), those on restrictive diets (vegan, keto, or fasting), minors or adults over 65, or anyone currently using probiotic/prebiotic products are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, this supplement could increase beneficial gut bacteria and improve metabolic risk markers, suggesting a new preventive approach for metabolic health.
How similar studies have performed: Related bile acid treatments like UDCA have been used clinically and shown to shift gut bacterial populations, while 7-KLCA has supportive in vitro and preclinical evidence but remains relatively untested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Reading
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.