10
Participants
Start Date
September 27, 2023
Primary Completion Date
January 8, 2024
Study Completion Date
April 11, 2024
TOTUM-448
The study is divided in two phases. The first clinical phase of the project is aimed at determining TOTUM-448's metabolites absorption peak (two galenic forms will be tested: capsules and powder). Then, human circulating metabolites from polyphenols will be quantified and characterized by ultra-high performance liquid chromatography hyphenated with tandem mass spectrometry (UPLC-MS/MS). Once the absorption profile is characterized, volunteers will visit once again the clinical center for the collection of serum fractions either naïve (before ingestion) or enriched (containing circulating metabolites following TOTUM-448 ingestion). The enriched fraction (circulating bioactive collection) will be collected at t-max as characterized in the first phase (absorption profil's peak). Finally, biological activity of TOTUM-448 on human hepatocytes will be studied by comparing naïve serum and serum containing circulating metabolites according to an in vitro protocol.
University Hospital Clermont-Ferrand, Clermont-Ferrand
Clinic'n'Cell
OTHER
University Hospital, Clermont-Ferrand
OTHER
Valbiotis
INDUSTRY