A Clinical Trial Evaluating the Influence of the Ingredients MyCondro™ and Bovine Chondroitin Sulfate on the Behavior of Cells in the Osteoarticular Sphere

Overview

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.

The hypothesis of this study is that chondroitin sulfate promotes the maintenance and preservation of the functionality of the skeleton (cartilage, joint capsule and bone tissue) and that the effect could be different depending on the origin and the process of obtaining these chondroitins sulfate. However, the bioavailability of this type of ingredient and the mechanisms of action that could support and differentiate the benefits on the osteoarticular sphere remain to be defined. Thus, this study aims to determine the biological activity of a human serum enriched with metabolites of interest from the consumption of the ingredients MyCondro™ (chondroitin sulfate of fermentative origin) and Bovine CS (chondroitin sulfate of animal origin) on the metabolism and function of skeletal cells (cartilage, joint capsule and bone tissue). The primary objective of the study is to determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and Bovine CS on the behavior of human primary cell cultures of cartilage, joint capsule and bone tissue. The secondary objective is to characterize the absorption kinetics of the ingredients MyCondro™ and Bovine CS. Furthermore, to extend the study to the metabolism of connective tissues that could be impacted, the influence of sera enriched with metabolites from the ingestion of the ingredient MyCondro™ will be explored on human primary dermal fibroblast cultures ex vivo. The study consists of two distinct phases. The 1st phase will determine the peak absorption of each product of the study in kinetics over 5 hours, after product ingestion. The 2nd phase will consist of a blood sample collected before the ingestion and at the peak of absorption after ingestion of each ingredient, to collect and compare two different serum fractions; naive and an enriched with metabolites and then culture the collected serum. The single-center study will be carried out in an open-label setting, on a cohort of 10 healthy volunteers per phase and per product. The ingredient will be taken in one go for each phase. Since each volunteer is his own control, inter-individual variation is limited. This approach aims at identifying ex vivo, the biological activity of enriched sera allowing satisfactory statistical power with very few volunteers.