Dietary Supplement for Joint: the OLE Study

Not Applicable

Completed

• Conditions: Knee Discomfort; Knee Pain

• Registration Number: NCT03072108
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-24
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of the effect of investigational product after 6 months of supplementation	From Baseline to 6 months of product administration and compared to Placebo	Biomarker of cartilage breakdown (Coll2.1-NO2)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effect of investigational product	From Baseline to 6 months of product administration and compared to Placebo	OARSI core set of performance-based tests

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liege, Belgium