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Knee DiscomfortNCT04420091

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

A study testing Cartidyss in people with Knee Discomfort, run by Abyss Ingredients at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Knee Discomfort
What is being tested?
Cartidyss
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesBelgium
Study dates
11 Jun 2020to 17 Dec 2020
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 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 24Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Hopital Princesse Paola, VIVALIA

    Marche-en-Famenne, 6900

  • Centre medical Chant d'Oiseau

    Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, 1150

Other trials in Belgium

About this study

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

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

Read the 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
Being tested
Cartidyss
Keywords
knee discomfort, hydrolyzed fish cartilage, food supplement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CartidyssDietary supplement

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

Study groups in NCT04420091
Study groupRoleWhat they receive
CartidyssExperimentalNot described
Receives: Dietary Supplement: Cartidyss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months (Day 0, Month 1 and Month 3)

Secondary outcomes (9)

  1. 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.

    Measured: 3 months (Day 0, Month 1 and Month 3)

  2. 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.

    Measured: 3 months (Day 0, Month 1 and Month 3)

  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.

    Measured: 3 months (Day 0, Month 1 and Month 3)

  4. 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.

    Measured: 3 months (Day 0, Month 1 and Month 3)

  5. 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

    Measured: Only Month 1 and Month 3

  6. Evaluate the compliance of Cartidyss after 3 months of supplementation

    Count the capsules in investigation kits brought back by the patient.

    Measured: Only Month 1 and Month 3

  7. 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.

    Measured: Only Month 1 and Month 3

  8. Evaluate the pain killer's consumption during the 3 months of supplementation

    Changes after supplementation. Count the number of consumed pain killer

    Measured: Only Month 1 and Month 3

  9. 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.

    Measured: Only Month 1 and Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start11 Jun 2020
  3. Primary completion17 Dec 2020
  4. Study completion17 Dec 2020

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420091
Sponsor's protocol ID
CARTIDYSS
Status last verified
Jan 2021
First submitted
28 May 2020
Last updated
6 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37735385

Questions about this trial

What is this clinical trial studying?

A study testing Cartidyss in people with Knee Discomfort, run by Abyss Ingredients at 2 sites in Belgium.

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 6 inclusion and 24 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation (time frame: 3 months (Day 0, Month 1 and Month 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420091, which also lists 1 linked publication.

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 6 Jan 2021.

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