Dietary Supplement for Joint: the OLE Study

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03072108
• Collaborator: Artialis (Industry)
• Enrollment: 124
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Discomfort; Knee Pain	Dietary Supplement: Bonolive; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Oleuropein-based Dietary Supplement (Bonolive™) Versus Placebo on Knee Joint Functionality and Cartilage Catabolism in Ageing Population
• Actual Study Start Date: Jun 24, 2016
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Evaluation of the effect of investigational product after 6 months of supplementation [From Baseline to 6 months of product administration and compared to Placebo]

   KOOS (Knee injury and Osteoarthritis Outcome Score)

2. 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

1. Evaluation of the effect of investigational product [From Baseline to 6 months of product administration and compared to Placebo]

   Knee pain VAS score at rest and at walking

2. 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

Other Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: 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

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Liège	Liege		Belgium	4000

Sponsors and Collaborators

• Nestlé
• Artialis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT03072108
• Other Study ID Numbers: 15.16.CLI
• First Posted: Mar 7, 2017
• Last Update Posted: Oct 9, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 9, 2018