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

NCT06800820 | Completed

• 1 other identifier: CnC2024 - ChondractivPlus
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Collagen hydrolysate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

Chondractiv™ Plus

OTHER

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)

Interventions

Chondractiv™ Plus (Hydrolyzed chicken cartilage) DIETARY_SUPPLEMENT

One oral dose

Chondractiv™ Plus

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any type of vaccination within the past month.
• Alcohol consumption exceeding WHO standards (Sup. 3 drinks per day for men).
• 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).
• 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

Sponsors & Collaborators

• Symrise Group: lead
• Clinic'n'Cell: collaborator

Study Sites (1)

Centre d'Investigation Clinique (PIC/CIC), Bâtiment 3C - 58, rue Montalembert

Clermont-Ferrand, 63003, France

Location

Study Officials

• Gisèle PICKERING, PhD

  CIC Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 30, 2025
• Study Start: January 23, 2025
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)