A Clinical Trial Evaluating the Influence of the Ingredients MyCondro™ and Bovine Chondroitin Sulfate on the Behavior of Cells in the Osteoarticular Sphere

NCT07727174 | Not Yet Recruiting

• 1 other identifier: CnC2025 - Gnosis
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the effect of chondroitin sulfate derived from fermentation (MyCondro™) and bovine chondroitin sulfate, on the health and function of the skeletal system ex vivo, including cartilage, joint capsule, and bone tissue. The primary aim of the study is to determine the influence of human sera enriched with metabolites resulting from the ingestion of the ingredients on the metabolism of human primary cells of cartilage (chondrocytes), joint capsule (synoviocytes) and bone tissue (osteoblasts). Furthermore, the absorption kinetics of MyCondro™ and Bovine CS will be described.

Conditions

Joint Health

Keywords

Joint mobility; Joint health; non-animal chondroitin sulfate; MyCondro™

Outcome Measures

Primary Outcomes (3)

• Cell proliferation properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion

  To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the behavior of cells in the osteoarticular sphere

  up to 5 hours after intervention ingestion

• Cell metabolism properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion

  To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the synthesis of molecules involved in cartilage metabolism by primary cells of the osteoarticular sphere

  up to 5 hours after intervention ingestion

• Anti-inflammatory properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion

  To determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and bovine chondroitin sulfate on the expression of inflammatory cytokines by primary cells of the osteoarticular sphere

  up to 5 hours after intervention ingestion

Secondary Outcomes (1)

• Pharmacokinetics and absorption profiles

  up to 5 hours after intervention ingestion

Other Outcomes (1)

• Influence of MyCondro on human primary dermal fibroblast ex vivo cell viability and proliferation

  up to 5 hours after intervention ingestion

Study Arms (2)

Non-animal chondroitin sulfate

EXPERIMENTAL

The 10 selected volunteers will go to the PIC/CIC in the morning on an empty stomach to determine the peak absorption (phase 1 - ingredient n°1) related to the ingestion of the MyCondro™ ingredient. Once the peak of absorption is known, the same 10 volunteers with the exception of study drop-out will be contacted for a second step of sampling (Phase 2) to collect both types of serum, a naive fraction (1) and a fraction enriched with metabolites of interest (2) at the time of peak absorption (blood samples (1) at t=0 before ingestion of the ingredient; (2) at t = peak absorption)

Dietary Supplement: MyCondro™

Animal-derived chondroitin sulfate

ACTIVE COMPARATOR

The 10 selected volunteers will go to the clinical site in the morning on an empty stomach to determine the peak absorption (phase 1 - ingredient n°2) related to the ingestion of the Bovine chondroitin ingredient. Once the peak of absorption is known, the 10 volunteers with the exception of study drop-out will be contacted for a second step of sampling (Phase 2) to collect both type of serum, a naive fraction (1) and a fraction enriched with metabolites of interest (2) at the time of peak absorption (blood samples (1) at t=0 before ingestion of the ingredient ; (2) at t = peak absorption)

Dietary Supplement: Bovine chondroitin sulfate

Interventions

MyCondro™ DIETARY_SUPPLEMENT

This is a non-animal chondroitin sulfate

Also known as: Ingredient n°1

Non-animal chondroitin sulfate

Bovine chondroitin sulfate DIETARY_SUPPLEMENT

This is animal-derived chondroitin of bovine origin

Also known as: Ingredient n°2

Animal-derived chondroitin sulfate

Eligibility Criteria

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

You may qualify if:

• Men.
• years old (terminals included).
• Liver test in the reference standards.
• Renal assessment in the reference standards.
• NFS in the reference standards.
• CRP in the reference standards.
• Blood pressure compatible with the conduct of the study.
• Non-smoker or occasional smoker (\<5 cigarettes/day or \< 10ml per week of electronic cigarette liquid dosed at 3 mg/ml of nicotine).
• \< to 5 hours of intense sport per week.
• Weight≥ to 60 kg.
• BMI between 20 and 28 kg/m² (terminals not included).
• Subjects able and willing to comply with the protocol and provide written informed consent.
• Subjects affiliated to social security

You may not qualify if:

• All types of vaccination under one month.
• Alcohol consumption above WHO standards (\>3 glasses of alcohol per day for men).
• Known pathology (including seasonal).
• Allergy to the study product (all types)
• People with a diet that is not suitable for the conduct of the study (e.g. vegetarian, vegan or vegan diet).
• Medical and/or surgical history judged by the investigator or his/her representative to be incompatible with the trial.
• Persons under guardianship, curatorship, deprivation of liberty, safeguard of justice.
• Refusal to sign the information sheet and consent.
• Refusal to be registered on the National Register of Volunteers who lend themselves to research involving the human person.
• Person who is excluded from another study on the national volunteer database, or who has received more than €6000 in the year following their participation in clinical studies.

Sponsors & Collaborators

• Lesaffre International: lead
• Clinic'n'Cell: collaborator
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (1)

Centre d'investigation clinique | CIC

Clermont-Ferrand, Cedex 1, 63003, France

Location

Study Officials

• Gisèle PICKERING

  Head of Department - Investigation Platform Clinical - CHU Clermont-Ferrand Clinical Investigation Center, Inserm CIC

  PRINCIPAL INVESTIGATOR

• Yohann Wittrant

  Scientific Coordinator Clinic'n'Cell - Faculty of Medicine and Pharmacy - Clermont-Ferrand - France

  STUDY DIRECTOR

Central Study Contacts

Clinical Project Manager

CONTACT

+4915163496903; v.oyedokun@gnosis.lesaffre.com

Director of Substantiation

CONTACT

y.fardini@gnosis.lesaffre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): August 26, 2026
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)