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 - BTS1289/18

InterHealth– A Lonza Group Company0 个研究点目标入组 96 人开始时间: 2019年9月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•* 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

发起方

InterHealth– A Lonza Group Company