Status:
COMPLETED
Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption
Lead Sponsor:
Valbiotis
Collaborating Sponsors:
Clinic'n'Cell
University Hospital, Clermont-Ferrand
Conditions:
NAFLD
MASLD
Eligibility:
MALE
18-35 years
Phase:
NA
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 lipi...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06047847
Start Date
September 27 2023
End Date
April 11 2024
Last Update
May 31 2024
Active Locations (1)
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1
University Hospital Clermont-Ferrand
Clermont-Ferrand, France, 63003