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.
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
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)
Parallel
7-KLCA
Dietary supplementThis 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
Dietary supplementThis 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.
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).
Change in production of SCFA by the gut microbiota
Gas chromatography will be used to analyse changes in SCFA content in stool to assess the activity of the gut microbiota as a result of 7-KLCA intervention.
Blood markers of health
Fasting blood glucose, Hb1Ac (baseline and Week 12), blood lipids (total cholesterol, HDL, LDL, triglycerides), liver function (ALT, AST), kidney function (eGFR, creatnine), inflammatory markers (CRP, ESR) and immune markers (TNF-alpha, IL-6) will be measured to assess the benefits of 7-KLCA, which may help reduce the risk of developing disease.
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University of Reading
Lead sponsor
ABC Farmaceutici S.p.A.
Collaborator
