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

NCT04420091 | Completed DMC

• 1 other identifier: CARTIDYSS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Conditions

Knee Discomfort

Keywords

knee discomfort; hydrolyzed fish cartilage; food supplement

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Evaluate the effect of Cartidyss on knee function after 3 months of supplementation

  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

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

• Evaluate the effect of Cartidyss on patient global assessment after 3 months of supplementation

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

• Evaluate the effect of Cartidyss on quality of life after 3 months of supplementation

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

• Evaluate the tolerance of Cartidyss after 3 months of supplementation

  Only Month 1 and Month 3

Study Arms (1)

Cartidyss

EXPERIMENTAL

Dietary Supplement: Cartidyss

Interventions

Cartidyss 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

Cartidyss

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Abyss Ingredients: lead
• Artialis: collaborator

Study Sites (2)

Centre medical Chant d'Oiseau

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

Location

Hopital Princesse Paola, VIVALIA

Marche-en-Famenne, 6900, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37735385 DERIVED

Study Officials

• Charles Chapelle, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 9, 2020
• Study Start: June 11, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

BE (2)