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

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Reading

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • 7-KLCA
  • Maltodextrin

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Reading

Lead sponsor

ABC Farmaceutici S.p.A.

Collaborator