Determination of Biological Activity of Human-enriched Serum Following Chondractiv™ Plus Ingredient Ingestion

Determination of Biological Activity of Human-enriched Serum Following Chondractiv™ Plus Ingredient Ingestion : Result From an Exploratory Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Chondractiv™ Plus (Hydrolyzed chicken cartilage)

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Centre d'Investigation Clinique (PIC/CIC), Bâtiment 3C - 58, rue Montalembert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Chondractiv™ Plus; Phase 1: One dose of 1,5g or 4,5g or 15g Phase 2: One dose of 15g	Dietary supplement: Chondractiv™ Plus (Hydrolyzed chicken cartilage); One oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Symrise Group
• Collaborators: Clinic'n'Cell
• Investigators: Principal Investigator: Gisèle PICKERING, PhD, CIC Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Collagen hydrolysate
• Other Study ID Numbers: CnC2024 - ChondractivPlus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No