NCT06047847Completed
Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
Determination of Biological Activity of Enriched Serum Among Healthy Participants After Consumption of the Food Supplement TOTUM-448
Source: ClinicalTrials.gov · Last updated 31 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 5 Sept 2023
- Start date
- 27 Sept 2023
- Primary completion date
- 8 Jan 2024
- Lead sponsor
- Valbiotis
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06047847
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 27 Sept 2023 to the primary completion date, 8 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 35 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.