Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
- Conditions
- Mild Inflammatory ContextNAFLDMASLD
- Interventions
- Dietary Supplement: TOTUM-448
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
- 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
- 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
- Arm && Interventions
Group Intervention Description TOTUM-448 TOTUM-448 10 healthy men will consume an acute intake of 4.284g of TOTUM-448 on three separate occasions. Phase 1: once per galenic form (capsule and powder). Phase 2: once (capsule only).
- 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