Clinical trial NCT06047847: Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
Official title: Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
MASLD
Mild Inflammatory Context
Keywords: ex vivo
lipid metabolism
inflammation
hepatocytes
oxidative stress
plant extract
polyphenols
dietary/food supplement
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
Collaborators: name: Clinic'n'Cell
name: University Hospital, Clermont-Ferrand
First posted: 2023-09-21
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An ex vivo clinical approach.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
measure: 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.
timeFrame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
measure: 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.
timeFrame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
measure: 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.
timeFrame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
measure: 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.
timeFrame: At phenolic compounds t-max obtained during kinetic phase. Note: According to previous studies, t-max is expected around 60 minutes.
Secondary outcomes:
measure: Time to reach the maximum concentration in serum of detectable polyphenol metabolite concentrations by UPLC-MS/MS.
timeFrame: From timepoint 0 minute to timepoint 240 minutes.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle Pickering, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.