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Completed

NCT Number: NCT06800820

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chondractiv™ Plus (Hydrolyzed chicken cartilage)

Dietary Supplement

One oral dose

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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).

  2. 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

    Characterize changes in plasma proteome after consumption of the ingredient Chondractiv™ Plus (phase 1).

Sponsors and collaborators

Lead sponsor

Symrise Group

Industry

Collaborators

  • Clinic'n'Cell

Registry information

Official study title

Determination of Biological Activity of Human-enriched Serum Following Chondractiv™ Plus Ingredient Ingestion : Result From an Exploratory Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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