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

Not Applicable

Completed

• Conditions: Mild Inflammatory Context; NAFLD; MASLD

• Registration Number: NCT06047847
• Lead Sponsor: Valbiotis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2023-09-27
• Primary Completion: 2024-01-08
• Study Completion: 2024-04-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on oxidative stress status of human hepatocytes in a hyperlipidic pro-inflammatory context.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive 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.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on triglyceride storage of human hepatocytes in a hyperlipidic pro-inflammatory context.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on cholesterol storage of human hepatocytes in a hyperlipidic pro-inflammatory context.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.
Evaluate the influence of circulating bioactive metabolites in blood stream resulting from the intake of TOTUM-448 on viability of human hepatocytes in a hyperlipidic pro-inflammatory context.	At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.	Naïve will be compared to enriched serum from the 10 healthy participants at the previously determined t-max.

Secondary Outcome Measures

Name	Time	Method
Time to reach the maximum concentration in serum of detectable polyphenol metabolite concentrations by UPLC-MS/MS.	From timepoint 0 minute to timepoint 240 minutes.	After ingestion of TOTUM-448 the concentration in serum of detectable polyphenol metabolites will be assessed every 20 minutes during 240 minutes.

Trial Locations

Locations (1)

University Hospital Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France