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Completed

NCT Number: NCT03072108

Dietary Supplement for Joint: the OLE Study

This clinical study evaluates if the oral administration of Bonolive can contribute to the improvement of functionnality in healthy elderly people with knee discomfort.

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Key information

Conditions

Knee Discomfort Knee Pain

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female ≥ 55 years of age
  • BMI between 18.5 and 29.9 kg/m2 (normo and overweight)
  • Moderate knee pain (the most painful knee is considered)
  • Able to follow the instructions of the study
  • Able to perform physical tests
  • Having signed an informed consent

Exclusion criteria

Related to knee

  • Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
  • Subject with knee/joint surgery/replacement and ACL (Cross Ligament) injury in the target knee
  • Concurrent articular disease interfering with the evaluation of pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis
  • Prosthesis in the target knee
  • Diagnosed arthrosis eligible to knee/joint surgery/replacement

Related to treatments

  • Analgesics to manage knee pain 24h before inclusion visit
  • Corticosteroids injection in the target knee in the month preceding inclusion
  • Hyaluronan injection in the target knee in the last 6 months
  • Oral corticotherapy ≥ 5mg/day in the last 3 months
  • Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
  • Other dietary supplements used for articular disorders in the last 3 months
  • An anticipated need for the duration of the trial of corticosteroids or hyaluronan injection, oral corticotherapy, arthroscopy, analgesics other than listed as rescue treatments, which are forbidden during the trial
  • Arthroscopy in the last 6 months
  • Allergy or contra-indication to Oleuropein, to maltodextrin or any ingredient present in the product, or intolerance to rescue treatment (Paracetamol and NSAIDs)
  • Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) during the year before inclusion

Related to associated diseases

  • Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, Parkinson, progressive malignant neoplasia or in remission for less than 5 years, HIV, etc.)
  • Lower or upper extremity surgery or fracture in the last 3 months
  • Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
  • Swallowing disorder

Related to patients

  • Close collaborators to the investigational team, the study coordinator (Artialis) or to the Sponsor (Nestlé)
  • Currently participating or having participated in another therapeutic clinical trial in the three previous months
  • Having made a blood donation in the past month
  • Under guardianship or judicial protection
  • Pregnancy, breastfeeding, planned conception
  • Premenopausal women or women without tubal ligation or contraception.

Treatment and study plan

Bonolive

Dietary Supplement

2 caps per day of Bonolive

Placebo

Dietary Supplement

2 caps per day of Placebo

Primary outcomes

  1. Evaluation of the effect of investigational product after 6 months of supplementation

    Time frame: From Baseline to 6 months of product administration and compared to Placebo

    KOOS (Knee injury and Osteoarthritis Outcome Score)

  2. Evaluation of the effect of investigational product after 6 months of supplementation

    Time frame: From Baseline to 6 months of product administration and compared to Placebo

    Biomarker of cartilage breakdown (Coll2.1-NO2)

Secondary outcomes

  1. Evaluation of the effect of investigational product

    Time frame: From Baseline to 6 months of product administration and compared to Placebo

    Knee pain VAS score at rest and at walking

  2. Evaluation of the effect of investigational product

    Time frame: From Baseline to 6 months of product administration and compared to Placebo

    OARSI core set of performance-based tests

Other outcomes

  1. Evaluation of food habits and frequency using patient-reported questionnaire

    Time frame: From the date of inclusion until end of study, on a monthly basis, up to 6 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Artialis

Registry information

Official study title

Effect of Oleuropein-based Dietary Supplement (Bonolive™) Versus Placebo on Knee Joint Functionality and Cartilage Catabolism in Ageing Population

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2017
Registry last updated
Oct 9, 2018

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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