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The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease.
Sponsor: University of Reading
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-04-06
Completion Date
2027-12-31
Last Updated
2026-03-30
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (1)
Hugh Sinclair Unit, Harry Nursten Building, University of Reading, Whiteknights Campus, RG6 6UR
Reading, United Kingdom