NCT03072108
Completed
Not Applicable
Effect of Oleuropein-based Dietary Supplement (Bonolive™) Versus Placebo on Knee Joint Functionality and Cartilage Catabolism in Ageing Population
Société des Produits Nestlé (SPN)1 site in 1 country124 target enrollmentStarted: June 24, 2016Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Evaluation of the effect of investigational product after 6 months of supplementation
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- Evaluation of the effect of investigational product(From Baseline to 6 months of product administration and compared to Placebo)
Investigators
Study Sites (1)
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