Knee DiscomfortNCT03072108
Dietary Supplement for Joint: the OLE Study
A study testing Bonolive in people with Knee Discomfort and Knee Pain, run by Société des Produits Nestlé (SPN) at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Discomfort, Knee Pain
- What is being tested?
- Bonolive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jun 2016to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Knee Discomfort, Knee Pain
- Being tested
- Bonolive, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonoliveDietary supplement
2 caps per day of Bonolive
PlaceboDietary supplement
2 caps per day of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bonolive | Experimental | Not described Receives: Dietary Supplement: Bonolive |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of investigational product after 6 months of supplementation
KOOS (Knee injury and Osteoarthritis Outcome Score)
Measured: 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)
Measured: From Baseline to 6 months of product administration and compared to Placebo
Secondary outcomes (2)
Evaluation of the effect of investigational product
Knee pain VAS score at rest and at walking
Measured: 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
Measured: From Baseline to 6 months of product administration and compared to Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start24 Jun 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072108
- Sponsor's protocol ID
- 15.16.CLI
- Status last verified
- Oct 2018
- First submitted
- 31 Jan 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oleuropein-based Dietary Supplement (Bonolive™) Versus Placebo on Knee Joint Functionality and Cartilage Catabolism in Ageing Population
- ClinicalTrials.gov ID
- NCT03072108
- Acronym / sponsor ID
- 15.16.CLI
- Conditions
- Knee Discomfort, Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bonolive | Experimental | Dietary Supplement: Bonolive |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bonolive2 caps per day of Bonolive | Dietary supplement | Bonolive |
| Placebo2 caps per day of Placebo | Dietary supplement | Placebo |
Primary outcome
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)
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)
2 secondary outcomes
Evaluation of the effect of investigational product
Time frame: From Baseline to 6 months of product administration and compared to Placebo
Evaluation of the effect of investigational product
Time frame: From Baseline to 6 months of product administration and compared to Placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonolive in people with Knee Discomfort and Knee Pain, run by Société des Produits Nestlé (SPN) at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.