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

NCT ID: NCT06800820

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-23
• Study Completion Date: 2025-04-03

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Chondractiv™ Plus

Phase 1: One dose of 1,5g or 4,5g or 15g

Phase 2: One dose of 15g

Group Type: OTHER

Chondractiv™ Plus (Hydrolyzed chicken cartilage)

Intervention Type: DIETARY_SUPPLEMENT

One oral dose

Interventions

Chondractiv™ Plus (Hydrolyzed chicken cartilage)

One oral dose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinic'n'Cell

OTHER

Sponsor Role: collaborator

Symrise Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle PICKERING, PhD

Role: PRINCIPAL_INVESTIGATOR

CIC Clermont-Ferrand

Locations

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

Clermont-Ferrand, , France

Countries

France

Other Identifiers

CnC2024 - ChondractivPlus

Identifier Type: -

Identifier Source: org_study_id