Hydrolyzed Fish Cartilage Effect on Knee Joint Functionality and Discomfort in Adult Population

NCT ID: NCT04420091

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2020-12-17

Brief Summary

This study is an exploratory, non-comparative, multi-centric trial in 30 free-living healthy male and female subjects with moderate knee joint discomfort and loss of functionality.

The objective of this trial is to determine whether oral administration of Cartidyss, a concentrated fish cartilage extract, can contribute to the improvement of knee joint functionality and discomfort in adult population

Detailed Description

30 patients will be enrolled during a 4-month period in 3 investigational sites and each patient will undergo 3 visits (V0: Inclusion visit at baseline, V1: Follow-Up Visit after 1 month ± 3 day and V2: End Visit after 3 months ± 5 days).

The primary objective of this trial is to determine whether oral administration of Cartidyss, a concentrated fish cartilage extract, can contribute to the improvement of knee joint functionality and discomfort in adult population, using a specific self-administered questionnaire. The secondary objectives of the study are to evaluate the effect of Cartidyss on knee function and pain at rest and while walking, with patient global assessment and quality of life at each time point. The tolerance, compliance, satisfaction, rate of responder to the supplementation and pain killer's consumption would be also evaluated as secondary endpoints.

Conditions

Knee Discomfort

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cartidyss

Group Type: EXPERIMENTAL

Cartidyss

Intervention Type: DIETARY_SUPPLEMENT

Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months

Interventions

Cartidyss

Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male or female
• Age limits (see above)
• Body Mass Index BMI ≤ 35 kg/m2
• Knee discomfort score at rest over the last 24 hours on the most painful knee evaluated on VAS (0-100) ≥ 40 at baseline
• Able to follow the instructions of the study
• Having signed an informed consent

Exclusion Criteria

• related to knee:

• Recent trauma (< 1 month) of the knee responsible of the symptomatic knee;
• Concurrent articular disease interfering with the evaluation of knee pain left to the Investigator's discretion
• Prosthesis in the target knee
• related to treatments:

• Analgesics to manage knee pain 24 hours before inclusion visit;
• Corticosteroids injection in the target knee in the last month;
• Hyaluronan injection in the target knee in the last 6 months;
• Arthroscopy in the last 6 months
• Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months;
• Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables int he last 3 months
• Contraindications to Cartidyss: hypersensitivity or allergy to the product components (fish)
• Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months
• related to associated diseases :

• Any severe, uncontrolled and limiting diseases left to the Investigator's discretion
• Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
• Anticipated need for any forbidden treatments during the trial
• Swallowing disorder
• Patient with widespread pain/depression (e.g. fibromyalgia)
• related to patients:

• Close collaborators to the investigational team, the study coordinator or to the Sponsor
• Currently participating or having participated in another therapeutic clinical trial in the last 3 months
• Under guardianship or judicial protection
• Pregnancy, breastfeeding, planned conception, or premenopausal women without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device), tubal ligation or hysterectomy

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Artialis

INDUSTRY

Sponsor Role: collaborator

Abyss Ingredients

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Chapelle, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Médical Chant d'Oiseau (WOLUWÉ-SAINT-PIERRE)

Locations

Centre medical Chant d'Oiseau

Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, Belgium

Hopital Princesse Paola, VIVALIA

Marche-en-Famenne, , Belgium

Countries

Belgium

References

Yves H, Herman J, Uebelhoer M, Wauquier F, Boutin-Wittrant L, Donneau AF, Monseur J, Fotso VM, Duquenne M, Wagner M, Bouvret E, Costes B, Wittrant Y. Oral supplementation with fish cartilage hydrolysate in an adult population suffering from knee pain and function discomfort: results from an innovative approach combining an exploratory clinical study and an ex vivo clinical investigation. BMC Musculoskelet Disord. 2023 Sep 21;24(1):748. doi: 10.1186/s12891-023-06800-4.

Reference Type: DERIVED

PMID: 37735385 (View on PubMed)

Other Identifiers

CARTIDYSS

Identifier Type: -

Identifier Source: org_study_id