Dietary Supplement for Joint: the OLE Study

Nestlé

Status

Completed

Conditions

Knee Discomfort

Knee Pain

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Bonolive

Study type

Interventional

Funder types

Industry

Identifiers

NCT03072108

15.16.CLI

Details and patient eligibility

About

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

Enrollment

124 patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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.