CompletedNot Applicable

Dietary Supplement for Joint: the OLE Study

Belgium124 participantsStarted 2016-06-24

Plain-language 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.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of the effect of investigational product after 6 months of supplementation

Timeframe: From Baseline to 6 months of product administration and compared to Placebo

Evaluation of the effect of investigational product after 6 months of supplementation

Timeframe: From Baseline to 6 months of product administration and compared to Placebo

Trial details

NCT IDNCT03072108

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-04-30

View on ClinicalTrials.gov More Knee Discomfort trials

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Evaluation of the effect of investigational product after 6 months of supplementation

Timeframe: From Baseline to 6 months of product administration and compared to Placebo

Evaluation of the effect of investigational product after 6 months of supplementation

Timeframe: From Baseline to 6 months of product administration and compared to Placebo