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NCT Number: NCT06047847

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

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.

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Inflammation Liver Diseases MASLD Mild Inflammatory Context Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Clermont-Ferrand

Clermont-Ferrand, 63003, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TOTUM-448

Dietary Supplement

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.

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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.

  5. 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.

    Time frame: 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 outcomes

  1. Time to reach the maximum concentration in serum of detectable polyphenol metabolite concentrations by UPLC-MS/MS.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Valbiotis

Industry

Collaborators

  • Clinic'n'Cell
  • University Hospital, Clermont-Ferrand

Registry information

Official study title

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

Acronym: CnC-TOTUM448

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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