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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Cartidyss-based Dietary Supplement on Knee Joint Functionality and Discomfort in Adult Population

Conditions
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Knee Discomfort

Intervention / Treatment
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* Dietary Supplement: Cartidyss


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cartidyss<br> | Dietary Supplement: Cartidyss<br>* Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation | Changes from baseline to 3 months of Knee injury and Osteoarthritis Outcome Score (KOOS) global score using a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale. | 3 months (Day 0, Month 1 and Month 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effect of Cartidyss on knee function after 3 months of supplementation | Changes from baseline to each time points of knee function using the KOOS questionnaire, a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale. | 3 months (Day 0, Month 1 and Month 3) | 
| Evaluate the effect of Cartidyss on knee pain at rest and while walking after 3 months of supplementation | Changes from baseline to each time points. Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month The pain Visual Analogue scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by 2 verbal descriptors, one for each symptom extreme. | 3 months (Day 0, Month 1 and Month 3) | 
| Evaluate the effect of Cartidyss on patient global assessment after 3 months of supplementation | Changes from baseline to each time points. Variation of Visual Analogue Scale for patient global assessment of disease activity The Visual Analogue Scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by one verbal descriptors for Global Assessment of disease activity. | 3 months (Day 0, Month 1 and Month 3) | 
| Evaluate the effect of Cartidyss on quality of life after 3 months of supplementation | Changes from baseline to each time points. A global score will be calculated in function of the answers of a Self-administered questionnaire (SF-36). The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. | 3 months (Day 0, Month 1 and Month 3) | 
| Evaluate the tolerance of Cartidyss after 3 months of supplementation | Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of System Organ Class (SOC) and Low Level Terms (LLT) using the last version of MedDRA) and drop offs | Only Month 1 and Month 3 | 
| Evaluate the compliance of Cartidyss after 3 months of supplementation | Count the capsules in investigation kits brought back by the patient. | Only Month 1 and Month 3 | 
| Evaluate the satisfaction of Cartidyss after 3 months of supplementation | Changes after supplementation. Self-administered questionnaire using a 5-Likert scale (extremely unsatisfied- unsatisfied- nor unsatisfied nor satisfied- satisfied- extremely satisfied) to evaluate the product. | Only Month 1 and Month 3 | 
| Evaluate the pain killer's consumption during the 3 months of supplementation | Changes after supplementation. Count the number of consumed pain killer | Only Month 1 and Month 3 | 
| Evaluate the rate of responder to the 3 months supplementation of Cartidyss | Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to the Outcome Measures in Rheumatology (OMERACT) and the OsteoArthritis Research Society International (OARSI) criteria. Responder criteria for osteoarthritis clinical trials based on the questionnaires describe above. | Only Month 1 and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee discomfort, hydrolyzed fish cartilage, food supplement