Impact of UC-II® on mobility and joint function in healthy subjects with activity-related joint discomfort (iMOVE) – a randomized, double-blind, placebo-controlled clinical study
- Conditions
- Healthy subjects
- Registration Number
- DRKS00018792
- Lead Sponsor
- InterHealth– A Lonza Group Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 96
* Body mass index (BMI) between 19 and 29.9 kg/m2
* Reversible knee-joint discomfort during or immediately after physical activity over a period of at least 3 months
* Performing joint bearing sports (at least 2 times per week with at least 20 min) and willing to maintain it during the whole study period
* Joint discomfort of at least 5 on an 11-point Likert scale while performing between 30 and 150 repetitions during the joint stress test via SLSD test
* Persons willing to abstain from regenerative actions or pain medication after the joint stress test via SLSD test until 24 hours after
* Smoker >5 cigarettes/ day
* Pregnant or nursing females
* History of hypersensitivity to eggs, chicken or any ingredients in the products
* Joint replacement of the knee or hip
* Diagnosed rheumatism, osteoarthritis or other inflammatory, infectious or metabolic joint disorders
* Planned surgical intervention of the knee and foot during the next 6 months
* Intra-articular therapy within the last 3 months
* Acute knee pain at rest or during light daily life activity
* Acute or history of musculoskeletal injury or previous severe joint injury at the knee joints (e.g. ligament rupture or sugical intervention of meniscus) if not more than 2 years ago
* 3 months prior to screening: chronic intake of supplements influencing joint health (e.g. glucosamine, chondroitin sulphate, collagen hydrolysate, curcumin, etc.)
* chronic intake of medication influencing joint health (e.g. corticoids)
* 30 days prior to screening: chronic use of pain relief medications (e.g. NSAIDs, analgesics, opioids, anti-depressants prescribed for painful conditions)
* history or presence of significant cardiovascular disease or co-morbidities (e.g. stroke, diabetes, etc.)
* elevated blood pressure measured during screening (>=140/90 mmHg) in subjects under hypertensive treatment or with diagnosed hypertension
* clinically significant disorders (e.g. Diabetes mellitus, neurological disorders, cancer, inflammatory bowel disease)
* vegan or vegetarian
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method