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| Name | Class |
|---|---|
| Clinic'n'Cell | OTHER |
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The main objective of this study is, after collecting serum enriched with metabolites of interest resulting from the ingestion of the Chondractiv™ Plus food supplement (an hydrolyzed chicken collagen), to determine the influence of these sera enriched with circulating metabolites on the behavior of human joint cartilage cells placed in culture.
The clinical study will be conducted in two phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondractiv™ Plus | Other | Phase 1: One dose of 1,5g or 4,5g or 15g Phase 2: One dose of 15g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondractiv™ Plus (Hydrolyzed chicken cartilage) | Dietary Supplement | One oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biological activity of human-enriched serum following Chondractiv™ Plus ingredient ingestion | The main objective of this study is to determine the influence of human serum enriched with metabolites from ingestion of Chondractiv™ Plus on the behavior of human primary chondrocyte cultures (phase 2). | T0 and Tmax (within 180 minutes after Chondractiv™ Plus ingredient ingestion, time determined during phase 1 described in secondary outcome) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of circulating amino-acids including hydroxyproline in blood stream. The aim is to characterize the absorption kinetics profile of Chondractiv™ Plus according to the dose ingested (phase 1). | Characterize the absorption kinetics profile of Chondractiv™ Plus according to the dose ingested by measuring the circulating metabolites level and in particular amino acids such as hydroxyproline - present in the ingredient (phase 1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle PICKERING, PhD | CIC Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique (PIC/CIC), Bâtiment 3C - 58, rue Montalembert | Clermont-Ferrand | 63003 | France |
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Phase 1: 15 healthy volunteers divided in 3 groups
Phase 2: 10 volunteers taking 1 dose of Chondractiv™ Plus 15g.
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| From blood draw at different time points (T0, T30, T60, T90, T120, T180 minutes) over the 3 hours following the ingestion of the Chondractiv™ Plus |
| Proteomic | Characterize changes in plasma proteome after consumption of the ingredient Chondractiv™ Plus (phase 1). | From blood draw at different time points (T0, T30, T60, T90, T120, T180 minutes) over the 3 hours following the ingestion of the Chondractiv™ Plus |