HealthyNCT06800820
Determination of Biological Activity of Human-enriched Serum Following Chondractiv™ Plus Ingredient Ingestion
A study testing Chondractiv™ Plus (Hydrolyzed chicken cartilage) in people with Healthy, run by Symrise Group at 1 site in France.
Trial 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… 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
- Healthy
- What is being tested?
- Chondractiv™ Plus (Hydrolyzed chicken cartilage)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2025to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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).
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique (PIC/CIC), Bâtiment 3C - 58, rue Montalembert
Clermont-Ferrand, 63003
About this study
Official title: Determination of Biological Activity of Human-enriched Serum Following Chondractiv™ Plus Ingredient Ingestion : Result From an Exploratory Clinical Trial
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.
Read the detailed description
The clinical study will be conducted in two phases.
- 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.
- 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
- Being tested
- Chondractiv™ Plus (Hydrolyzed chicken cartilage)
- Keywords
- Collagen hydrolysate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondractiv™ Plus (Hydrolyzed chicken cartilage)Dietary supplement
One oral dose
| Study group | Role | What they receive |
|---|---|---|
| Chondractiv™ Plus | Other | Phase 1: One dose of 1,5g or 4,5g or 15g
Phase 2: One dose of 15g Receives: Dietary Supplement: Chondractiv™ Plus (Hydrolyzed chicken cartilage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Characterize the absorption kinetics profile of Chondractiv™ Plus according to the dose ingested by measuring the circulating metabolites level and in particular amino acids such as hydroxyproline - present in the ingredient (phase 1).
Measured: 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
Characterize changes in plasma proteome after consumption of the ingredient Chondractiv™ Plus (phase 1).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start23 Jan 2025
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symrise Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, PhD, Principal investigator, CIC Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800820
- Sponsor's protocol ID
- CnC2024 - ChondractivPlus
- Status last verified
- May 2025
- First submitted
- 9 Jan 2025
- Last updated
- 16 May 2025
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Biological Activity of Human-enriched Serum Following Chondractiv™ Plus Ingredient Ingestion : Result From an Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06800820
- Acronym / sponsor ID
- CnC2024 - ChondractivPlus
- Conditions
- Healthy
- Keywords
- Collagen hydrolysate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Symrise GroupIndustry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 30 Jan 2025 (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 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.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chondractiv™ Plus | Other | Dietary Supplement: Chondractiv™ Plus (Hydrolyzed chicken cartilage)Phase 1: One dose of 1,5g or 4,5g or 15g Phase 2: One dose of 15g |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Chondractiv™ Plus (Hydrolyzed chicken cartilage)One oral dose | Dietary supplement | Chondractiv™ Plus |
Primary outcome
Biological activity of human-enriched serum following Chondractiv™ Plus ingredient ingestion
Time frame: T0 and Tmax (within 180 minutes after Chondractiv™ Plus ingredient ingestion, time determined during phase 1 described in secondary outcome)
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).
2 secondary outcomes
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).
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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. This study is not recruiting at the moment.
Gisèle PICKERING, PhD principal investigator
CIC Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chondractiv™ Plus (Hydrolyzed chicken cartilage) in people with Healthy, run by Symrise Group 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 16 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological activity of human-enriched serum following Chondractiv™ Plus ingredient ingestion (time frame: T0 and Tmax (within 180 minutes after Chondractiv™ Plus ingredient ingestion, time determined during phase 1 described in secondary outcome)). 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 16 May 2025.