Clinical trial NCT03072108: Dietary Supplement for Joint: the OLE Study
Official title: Effect of Oleuropein-based Dietary Supplement (Bonolive™) Versus Placebo on Knee Joint Functionality and Cartilage Catabolism in Ageing Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Discomfort
Knee Pain
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Artialis
First posted: 2017-03-07
Enrollment: 124
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the effect of investigational product after 6 months of supplementation
timeFrame: From Baseline to 6 months of product administration and compared to Placebo
measure: Evaluation of the effect of investigational product after 6 months of supplementation
timeFrame: From Baseline to 6 months of product administration and compared to Placebo
Secondary outcomes:
measure: Evaluation of the effect of investigational product
timeFrame: From Baseline to 6 months of product administration and compared to Placebo
measure: Evaluation of the effect of investigational product
timeFrame: From Baseline to 6 months of product administration and compared to Placebo
Other outcomes:
measure: Evaluation of food habits and frequency using patient-reported questionnaire
timeFrame: From the date of inclusion until end of study, on a monthly basis, up to 6 months
Locations:
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
Study officials:
References: