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Trial record 3 of 7 for:    oleuropein

Dietary Supplement for Joint: the OLE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072108
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Artialis
Information provided by (Responsible Party):
Nestlé

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : June 24, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]
    KOOS (Knee injury and Osteoarthritis Outcome Score)

  2. 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 Outcome Measures :
  1. Evaluation of the effect of investigational product [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From the date of inclusion until end of study, on a monthly basis, up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072108


Locations
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Belgium
Centre Hospitalier Universitaire de Liège
Liege, Belgium, 4000
Sponsors and Collaborators
Nestlé
Artialis

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03072108     History of Changes
Other Study ID Numbers: 15.16.CLI
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No