Trials / Completed
CompletedNCT06047847
Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Valbiotis · Industry
- Sex
- Male
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
Summary
Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. The hypothesis of this study is that TOTUM-448 promotes the normal function of hepatocytes in a mild inflammatory context. To determine the cellular and molecular effects of TOTUM-448, circulating bioactive molecules after TOTUM-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by Clinic'n'Cell.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-09-27
- Primary completion
- 2024-01-08
- Completion
- 2024-04-11
- First posted
- 2023-09-21
- Last updated
- 2024-05-31
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06047847. Inclusion in this directory is not an endorsement.