Healthy
Conditions
Keywords
Collagen hydrolysate
Brief summary
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.
Detailed description
The clinical study will be conducted in two phases. 1. The first phase will aim at characterizing the metabolites present in human serum after consumption of the Chondractiv™ ingredient and at determining the overall absorption peak of the tested ingredient. 2. The second phase will involve collecting sera enriched with metabolites at the absorption peak, following the ingestion of the ingredient. Subsequently, the final objective will be to characterize the influence of these sera enriched with metabolites of interest on the behavior of human joint cartilage cell cultures.
Interventions
DIETARY_SUPPLEMENTChondractiv™ Plus (Hydrolyzed chicken cartilage)
One oral dose
Sponsors
Clinic'n'Cell
Symrise Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Phase 1: 15 healthy volunteers divided in 3 groups * Group 1: 5 volunteers taking 1 oral dose of Chondractiv™ Plus 1,5g * Group 2: 5 volunteers taking 1 oral dose of Chondractiv™ Plus 4,5g * Group 3: 5 volunteers taking 1 oral dose of Chondractiv™ Plus 15g Phase 2: 10 volunteers taking 1 dose of Chondractiv™ Plus 15g.
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Liver function tests within reference norms. * Kidney function tests within reference norms. * Complete blood count (CBC) within reference norms. * C-reactive protein (CRP) within reference norms. * Blood pressure compatible with study requirements. * Non-smoker or occasional smoker (max 5 cigarettes/day or max 10 ml per week of e-liquid with a nicotine concentration of 3 mg/ml). * Maximum 5 hours of intense sports per week. * Weight ≥ 60 kg. * Body Mass Index (BMI) between 20 and 28 kg/m² (exclusive). * Subjects who are able and willing to comply with the protocol and give their informed written consent. * Subjects affiliated with the social security.
Exclusion criteria
* Any type of vaccination within the past month. * Alcohol consumption exceeding WHO standards (Sup. 3 drinks per day for men). * Ongoing treatment (medication, dietary supplement, or probiotic) and within the four weeks prior to inclusion. * Known pathology (including seasonal). * Allergy to the study product * Individuals following a diet unsuitable for the study (e.g., vegetarian, vegan, or plant-based diets). * Change in eating habits within the 4 weeks prior to inclusion. * Medical and/or surgical history deemed incompatible with the trial by the investigator or their representative. * Persons under guardianship, curatorship, deprived of freedoms, safeguarding justice. * Refusal to sign the information sheet and consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological activity of human-enriched serum following Chondractiv™ Plus ingredient ingestion | T0 and Tmax (within 180 minutes after Chondractiv™ Plus ingredient ingestion, time determined during phase 1 described in secondary outcome) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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 | 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). |
| Proteomic | 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 | Characterize changes in plasma proteome after consumption of the ingredient Chondractiv™ Plus (phase 1). |
Countries
France
Outcome results
None listed