Healthy subjects
Conditions
Interventions
Group 1: UC-II® (undenatured type II collagen), 40 mg/day (1 capsule) over 24 weeks
Group 2: Placebo (Microcristalline cellulose), 1 capsule / day, over 24 weeks
Sponsors
InterHealth– A Lonza Group Company
Eligibility
Sex/Gender
All
Age
20 Years to 55 Years
Inclusion criteria
Inclusion criteria: * 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
Exclusion criteria
Exclusion criteria: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repetitions to reach 5 on an 11-point Likert scale while performing the joint stress test via the single-leg-step-down (SLSD) test after the 6 months intervention phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of mobility/ joint function: * Repetitions to first onset of pain while performing the joint stress test via SLSD test (=2 on Likert scale) * Reach test (before performing the joint stress test via SLSD test) * Flexibility/ Range of motion knee joint (passive and active) Assessment of joint discomfort: * Joint discomfort while performing the SLSD test after the number of repetitions performed during the baseline (visit 1) SLSD test (if applicable) * Knee joint discomfort during regular sports * Retrospective joint discomfort (KOOS) * Global assessment * Responder analysis, defined as subjects not reaching pain level of 5 during 200 step downs * Reduction in teh occasional use of OTC pain medication Recovery Parameters: * Acute knee joint discomfort (at rest and after single-leg squat; pre, 0h, 30 min, 2 h post) * Acute knee joint discomfort (at rest) (12h and 24 h post) * Time to complete relief of pain post-completion of SLSD test * Average duration of pain during normal sporting activities. | — |
Countries
Germany
Contacts
Public ContactKatharina Knaub
BioTeSys GmbH
Outcome results
None listed