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

ConditionJoint Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-35
SponsorLesaffre International

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men.

18-35 years old (terminals included).

Liver test in the reference standards.

Renal assessment in the reference standards.

Disqualifiers

All types of vaccination under one month.

Alcohol consumption above WHO standards (>3 glasses of alcohol per day for men).

Ongoing treatment (medication, dietary supplement or probiotic) and within 4 weeks prior to inclusion.

Known pathology (including seasonal).

Trial design

Design model

Sequential

Treatments tested in this trial

  • MyCondro™

    Dietary supplement

    This is a non-animal chondroitin sulfate

  • Bovine chondroitin sulfate

    Dietary supplement

    This is animal-derived chondroitin of bovine origin

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Non-animal chondroitin sulfateExperimental treatment 1 intervention
Group B: Animal-derived chondroitin sulfateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 5 hours after intervention ingestion
2

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

Time frame
up to 5 hours after intervention ingestion
3

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

Time frame
up to 5 hours after intervention ingestion

Secondary outcomes

1

Pharmacokinetics and absorption profiles

To characterize the absorption kinetics of by measuring the levels of ingredients MyCondro™ and bovine chondroitin sulfate circulating in the blood. The absorption kinetics of will be measured by the levels of chondroitin sulfate circulating in the blood using ELISA method.

Time frame
up to 5 hours after intervention ingestion

Other outcomes

1

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

To determine the influence of Metabolism of primary dermal fibroblast cells measured by biological activitycell viability and proliferation of MyCondro contiaining SERA sera on ex vivo cell culture models

Time frame
up to 5 hours after intervention ingestion

Sponsors and contacts

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Lesaffre International

Lead sponsor

Clinic'n'Cell

Collaborator

University Hospital, Clermont-Ferrand

Collaborator

This trial is not recruiting at the moment. You can still explore other options: