Dietary Supplement for Joint: the OLE Study

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

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

Conditions
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Knee Discomfort, Knee Pain

Intervention / Treatment
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* Dietary Supplement: Bonolive
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bonolive<br> | Dietary Supplement: Bonolive<br>* 2 caps per day of Bonolive<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 2 caps per day of Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of investigational product after 6 months of supplementation | KOOS (Knee injury and Osteoarthritis Outcome Score) | From Baseline to 6 months of product administration and compared to Placebo | 
| Evaluation of the effect of investigational product after 6 months of supplementation | Biomarker of cartilage breakdown (Coll2.1-NO2) | From Baseline to 6 months of product administration and compared to Placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of investigational product | Knee pain VAS score at rest and at walking | From Baseline to 6 months of product administration and compared to Placebo | 
| Evaluation of the effect of investigational product | OARSI core set of performance-based tests | From Baseline to 6 months of product administration and compared to Placebo |