Joint HealthNCT07727174
A Clinical Trial Evaluating the Influence of the Ingredients MyCondro™ and Bovine Chondroitin Sulfate on the Behavior of Cells in the Osteoarticular Sphere
A study testing MyCondro™ and Bovine chondroitin sulfate in people with Joint Health, run by Lesaffre International at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Joint Health
- What is being tested?
- MyCondro™ and Bovine chondroitin sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men.
- 18-35 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.
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- 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
Who cannot join
- 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).
- 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).
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- Change in eating habits in the 4 weeks prior to inclusion.
- Medical and/or surgical history judged by the investigator or his/her representative to be incompatible with the trial.
- Blood donation made in the 3 months prior to the inclusion visit or intending to do so during the study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Director of Substantiation contact
France1 site, 1 recruiting
- Recruiting
Centre d'investigation clinique | CIC
Clermont-Ferrand, Cedex 1, 63003
Gisèle PICKERING Study Principal Investigator, +33 04 73 17 84 16, gisele.pickering@uca.fr
About this study
Official title: Determination of the Biological Activity of Enriched Sera From Healthy Volunteers After Consumption of Chondroitin Sulfate of Both Animal and Fermentative Origin
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.
Read the detailed description
The hypothesis of this study is that chondroitin sulfate promotes the maintenance and preservation of the functionality of the skeleton (cartilage, joint capsule and bone tissue) and that the effect could be different depending on the origin and the process of obtaining these chondroitins sulfate. However, the bioavailability of this type of ingredient and the mechanisms of action that could support and differentiate the benefits on the osteoarticular sphere remain to be defined. Thus, this study aims to determine the biological activity of a human serum enriched with metabolites of interest from the consumption of the ingredients MyCondro™ (chondroitin sulfate of fermentative origin) and Bovine CS (chondroitin sulfate of animal origin) on the metabolism and function of skeletal cells (cartilage, joint capsule and bone tissue).
The primary objective of the study is to determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and Bovine CS on the behavior of human primary cell cultures of cartilage, joint capsule and bone tissue. The secondary objective is to characterize the absorption kinetics of the ingredients MyCondro™ and Bovine CS. Furthermore, to extend the study to the metabolism of connective tissues that could be impacted, the influence of sera enriched with metabolites from the ingestion of the ingredient MyCondro™ will be explored on human primary dermal fibroblast cultures ex vivo.
The study consists of two distinct phases. The 1st phase will determine the peak absorption of each product of the study in kinetics over 5 hours, after product ingestion.
The 2nd phase will consist of a blood sample collected before the ingestion and at the peak of absorption after ingestion of each ingredient, to collect and compare two different serum fractions; naive and an enriched with metabolites and then culture the collected serum.
The single-center study will be carried out in an open-label setting, on a cohort of 10 healthy volunteers per phase and per product. The ingredient will be taken in one go for each phase. Since each volunteer is his own control, inter-individual variation is limited. This approach aims at identifying ex vivo, the biological activity of enriched sera allowing satisfactory statistical power with very few volunteers.
- Conditions
- Joint Health
- Being tested
- MyCondro™, Bovine chondroitin sulfate
- Keywords
- Joint mobility, Joint health, non-animal chondroitin sulfate, MyCondro™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyCondro™Dietary supplement
Also called Ingredient n°1
This is a non-animal chondroitin sulfate
Bovine chondroitin sulfateDietary supplement
Also called Ingredient n°2
This is animal-derived chondroitin of bovine origin
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Bovine chondroitin sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: up to 5 hours after intervention ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start26 Aug 2026
- Primary completion8 Dec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, Head of Department - Investigation Platform Clinical - CHU Clermont-Ferrand Clinical Investigation Center, Inserm CICYohann Wittrant, Study director, Scientific Coordinator Clinic'n'Cell - Faculty of Medicine and Pharmacy - Clermont-Ferrand - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727174
- Sponsor's protocol ID
- CnC2025 - Gnosis
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Biological Activity of Enriched Sera From Healthy Volunteers After Consumption of Chondroitin Sulfate of Both Animal and Fermentative Origin
- ClinicalTrials.gov ID
- NCT07727174
- Acronym / sponsor ID
- CnC2025 - Gnosis
- Conditions
- Joint Health
- Keywords
- Joint mobility, Joint health, non-animal chondroitin sulfate, MyCondro™
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell, University Hospital, Clermont-Ferrand
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 8 Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis of this study is that chondroitin sulfate promotes the maintenance and preservation of the functionality of the skeleton (cartilage, joint capsule and bone tissue) and that the effect could be different depending on the origin and the process of obtaining these chondroitins sulfate. However, the bioavailability of this type of ingredient and the mechanisms of action that could support and differentiate the benefits on the osteoarticular sphere remain to be defined. Thus, this study aims to determine the biological activity of a human serum enriched with metabolites of interest from the consumption of the ingredients MyCondro™ (chondroitin sulfate of fermentative origin) and Bovine CS (chondroitin sulfate of animal origin) on the metabolism and function of skeletal cells (cartilage, joint capsule and bone tissue).
The primary objective of the study is to determine the influence of human sera enriched with metabolites from the ingestion of the ingredients MyCondro™ and Bovine CS on the behavior of human primary cell cultures of cartilage, joint capsule and bone tissue. The secondary objective is to characterize the absorption kinetics of the ingredients MyCondro™ and Bovine CS. Furthermore, to extend the study to the metabolism of connective tissues that could be impacted, the influence of sera enriched with metabolites from the ingestion of the ingredient MyCondro™ will be explored on human primary dermal fibroblast cultures ex vivo.
The study consists of two distinct phases. The 1st phase will determine the peak absorption of each product of the study in kinetics over 5 hours, after product ingestion.
The 2nd phase will consist of a blood sample collected before the ingestion and at the peak of absorption after ingestion of each ingredient, to collect and compare two different serum fractions; naive and an enriched with metabolites and then culture the collected serum.
The single-center study will be carried out in an open-label setting, on a cohort of 10 healthy volunteers per phase and per product. The ingredient will be taken in one go for each phase. Since each volunteer is his own control, inter-individual variation is limited. This approach aims at identifying ex vivo, the biological activity of enriched sera allowing satisfactory statistical power with very few volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-animal chondroitin sulfate | Experimental | Dietary Supplement: MyCondro™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) |
| Animal-derived chondroitin sulfate | Active comparator | Dietary Supplement: Bovine chondroitin sulfateThe 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Men.
- 18-35 years old (terminals included).
- Liver test in the reference standards.
- Renal assessment in the reference standards.
- NFS in the reference standards.
Key exclusion criteria (13 listed)
- 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).
- Allergy to the study product (all types)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyCondro™Also: Ingredient n°1This is a non-animal chondroitin sulfate | Dietary supplement | Non-animal chondroitin sulfate |
| Bovine chondroitin sulfateAlso: Ingredient n°2This is animal-derived chondroitin of bovine origin | Dietary supplement | Animal-derived chondroitin sulfate |
Primary outcome
Cell proliferation properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
Time frame: up to 5 hours after intervention 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
Cell metabolism properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
Time frame: up to 5 hours after intervention 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
Anti-inflammatory properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion
Time frame: up to 5 hours after intervention 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
1 secondary outcome
Pharmacokinetics and absorption profiles
Time frame: up to 5 hours after intervention ingestion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Director of Substantiation contact
Gisèle PICKERING principal investigator
Head of Department - Investigation Platform Clinical - CHU Clermont-Ferrand Clinical Investigation Center, Inserm CIC
Yohann Wittrant study director
Scientific Coordinator Clinic'n'Cell - Faculty of Medicine and Pharmacy - Clermont-Ferrand - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyCondro™ and Bovine chondroitin sulfate in people with Joint Health, run by Lesaffre International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (+4915163496903, v.oyedokun@gnosis.lesaffre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell proliferation properties of human serum enriched with circulating metabolites after MyCondro's or bovine chondroitin sulfate ingestion (time frame: up to 5 hours after intervention ingestion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.