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

NAFLD Clinical Trial

— CnC-TOTUM448  

Official title:

Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047847
• Other study ID #: 2023-A00579-36
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Valbiotis
• Contact: Annie Bouchard-Mercier, PhD
• Phone: +1 (418) 656-2131
• Email: annie.bouchard[@]valbiotis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Main Inclusion Criteria:

• Lipid profile within reference values
• Glycemia < 100mg/dL
• Normal hepatic function
• Normal blood formulation
• Normal renal function
• BMI between 20 and 28kg/m2
• Non smoker or occasional smoker

Main Exclusion Criteria:

• All types of vaccination within one month
• Alcohol intakes superior to World Health Organization recommendations
• Ongoing pharmacological, dietary supplement and/or probiotic treatment
• Consumption of enriched functional foods or dietary supplements within two weeks of inclusion
• Any known disease
• Allergy to ingredients of the study product
• With dietary habits incompatible with the study conduct

Related Conditions & MeSH terms

• NAFLD

Intervention

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 bioactives 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.

Locations

Country	Name	City	State
France	University Hospital Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
Valbiotis	Clinic'n'Cell, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (1)

Wauquier F, Boutin-Wittrant L, Krisa S, Valls J, Langhi C, Otero YF, Sirvent P, Peltier S, Bargetto M, Cazaubiel M, Sapone V, Bouchard-Mercier A, Roux V, Macian N, Pickering G, Wittrant Y. Circulating Human Metabolites Resulting from TOTUM-070 Absorption (a Plant-Based, Polyphenol-Rich Ingredient) Improve Lipid Metabolism in Human Hepatocytes: Lessons from an Original Ex Vivo Clinical Trial. Nutrients. 2023 Apr 14;15(8):1903. doi: 10.3390/nu15081903. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the influence of circulating bioactives' metabolites in blood stream resulting from the intake of TOTUM-448 on viability of human hepatocytes in a hyperlipidic pro-inflammatory context.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Primary	Evaluate the influence of circulating bioactives' metabolites in blood stream resulting from the intake of TOTUM-448 on cholesterol storage of human hepatocytes in a hyperlipidic pro-inflammatory context.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Primary	Evaluate the influence of circulating bioactives' metabolites in blood stream resulting from the intake of TOTUM-448 on triglyceride storage of human hepatocytes in a hyperlipidic pro-inflammatory context.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Primary	Evaluate the influence of circulating bioactives' metabolites in blood stream resulting from the intake of TOTUM-448 on oxidative stress status of human hepatocytes in a hyperlipidic pro-inflammatory context.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Primary	Evaluate the influence of circulating bioactives' metabolites in blood stream resulting from the intake of TOTUM-448 on pro-inflammatory cytokine expression of human hepatocytes in a hyperlipidic pro-inflammatory context.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Secondary	Time to reach the maximum concentration in serum of detectable polyphenol metabolite concentrations by UPLC-MS/MS.	After ingestion of TOTUM-448 the concentration in serum of detectable polyphenol metabolites will be assessed every 20 minutes during 240 minutes.	From timepoint 0 minute to timepoint 240 minutes.