About this trial
The study evaluates the effect of chondroitin sulfate derived from fermentation (MyCondro™) and bovine chondroitin sulfate, on the health and function of the skeletal system ex vivo, including cartilage, joint capsule, and bone tissue. The primary aim of the study is to determine the influence of human sera enriched with metabolites resulting from the ingestion of the ingredients on the metabolism of human primary cells of cartilage (chondrocytes), joint capsule (synoviocytes) and bone tissue (osteoblasts). Furthermore, the absorption kinetics of MyCondro™ and Bovine CS will be described.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men.
18-35 years old (terminals included).
Liver test in the reference standards.
Renal assessment in the reference standards.
Disqualifiers
All types of vaccination under one month.
Alcohol consumption above WHO standards (>3 glasses of alcohol per day for men).
Ongoing treatment (medication, dietary supplement or probiotic) and within 4 weeks prior to inclusion.
Known pathology (including seasonal).
Trial design
Sequential
Treatments tested in this trial
MyCondro™
Dietary supplementThis is a non-animal chondroitin sulfate
Bovine chondroitin sulfate
Dietary supplementThis is animal-derived chondroitin of bovine origin
Treatment groups
Trial outcomes
Primary outcomes
Cell proliferation properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the behavior of cells in the osteoarticular sphere
Cell metabolism properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the synthesis of molecules involved in cartilage metabolism by primary cells of the osteoarticular sphere
Anti-inflammatory properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the expression of inflammatory cytokines by primary cells of the osteoarticular sphere
Secondary outcomes
Pharmacokinetics and absorption profiles
To characterize the absorption kinetics of by measuring the levels of ingredients MyCondro™ and bovine chondroitin sulfate circulating in the blood. The absorption kinetics of will be measured by the levels of chondroitin sulfate circulating in the blood using ELISA method.
Other outcomes
Influence of MyCondro on human primary dermal fibroblast ex vivo cell viability and proliferation
To determine the influence of Metabolism of primary dermal fibroblast cells measured by biological activitycell viability and proliferation of MyCondro contiaining SERA sera on ex vivo cell culture models
Sponsors and contacts
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Lesaffre International
Lead sponsor
Clinic'n'Cell
Collaborator
University Hospital, Clermont-Ferrand
Collaborator
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