M17.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Men and women >18 years - diagnosed gonarthrosis - WOMAC subscore pain >/=15 points, >/=150 mm, respectively
Exclusion criteria
Exclusion criteria: allergy or intolerance to any component of the test product - severe chronic diseases (tumors etc) - severe cardiovascular disease, renal failure, liver disease - chronic inflammatory joint diseases, infectious diseases of the joints - classification of Kellgren stage IV - BMI >40 kg/m² - chronic diseases of the gastrointestinal tract - taking additional glucosamine, chondroitin and hyaluronic acid-containing products before or during the study - intra-articular injections - intra-articular and systemic corticosteroid therapy - pain relief or ointments during the study - pregnancy and lactation - alcohol, drug addiction - incapacitated subjects - refusal or withdrawal of consent by the subjects - simultaneous participation in another clinical study or participation within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Score (Questionnaire), Measurement of changes after 24 weeks compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| generel health (questionnaire): at baseline and after 6, 12, 18 and 24 weeks - blood parameters (blood count, liver enzymes, glucose, HbA1c, blood lipids, hsCRP, vitamin C, vitamin D, selenium, glutathione peroxidase) (blood samples): at baseline and after 6, 12, 18 and 24 weeks- documentation of acute medication (questionnaire and diary): at baseline and after 6, 12, 18 and 24 weeks | — |
Countries
Germany
Contacts
Leibniz Universität Hannover Institut für Lebensmittelwissenschaft und Humanernährung