Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 27, 2023

Primary Completion Date

January 8, 2024

Study Completion Date

April 11, 2024

Conditions
NAFLDMASLDMild Inflammatory Context
Interventions
DIETARY_SUPPLEMENT

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.

Trial Locations (1)

63003

University Hospital Clermont-Ferrand, Clermont-Ferrand

All Listed Sponsors
collaborator

Clinic'n'Cell

OTHER

collaborator

University Hospital, Clermont-Ferrand

OTHER

lead

Valbiotis

INDUSTRY

NCT06047847 - Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption | Biotech Hunter | Biotech Hunter