Dietary Supplement for Joint: the OLE Study

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

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 Overview

• Status: Completed
• Conditions: Knee Pain; Knee Discomfort
• Intervention / Treatment: Dietary supplement: Bonolive; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 2 caps per day of Placebo
Experimental: Bonolive	Dietary supplement: Bonolive; 2 caps per day of Bonolive

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Evaluation of food habits and frequency using patient-reported questionnaire	From the date of inclusion until end of study, on a monthly basis, up to 6 months

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: Artialis

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 15.16.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No