Study design and selection of subjects of the exploratory clinical study
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This study was an exploratory, non-comparative, multi-centric trial in a minimum of 30 free-living healthy male and female subjects with moderate knee joint discomfort and loss of functionality. It included subjects from 2 centers in Belgium who were enrolled in the study from June 11th, 2020, to December 17th, 2020. The main inclusion criteria were age between 40 and 80 years with a body mass index (BMI) ≤ 35 kg/mAll subjects enrolled in the study were taking 2 capsules of FCH 500 mg each, once daily in the morning, preferably during a meal, with water, for 3 months. The FCH (Cartidyss® NG, Abyss Ingredients, Caudan, France) is a powder obtained from a standardized manufacturing process based on enzymatic hydrolysis of fish cartilage without preservatives or processing aids. Its natural composition contains collagen peptides (< 3000 Da), chondroitin sulfate and minerals, respectively 65%, 26%, and 9%, given as an indicative value. Written informed consent to participate in the study was obtained from all subjects before enrolment.