NCT02318875

Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Vivatech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Joints and muscles disorders are common symptoms in the population. They are characterized by swelling, pain, functional impairment and morning stiffness. These disorders can be really disabling and painful, affecting the person's quality life. The purpose of this clinical trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154 subjects complaining functional discomfort associated to joints and muscles disorders.

Detailed description

Epidemiological studies on prevalence and incidence of joints and muscles disorders are scares. Two epidemiological French studies recorded patients consulting their GP for widespread pain, whatever the cause. The most often cited pain localization was the musculoskeletal system (36-59% of the cases). In Europe the situation is similar, with arthritis and osteoarthritis representing the 42% of pains. According to the WHO (World Health Organization) the musculoskeletal system's disorders are the first cause of handicap in the worldwide population. Krill oil is low in both saturated fatty acids and monounsaturated fatty acid and high in polyunsaturated fatty acid including a high proportion of (n-3) fatty acids and particularly EPA and DHA. There are strong evidences that krill oil may improve the comfort of sensitive joints thank to its n-3 fatty acids and phospholipids content. Particularly, after a supplementation with a dietary product containing pure krill oil, a reduction of systemic inflammation, trough reduction of CRP, was concomitantly accompanied by improvement of various clinical scores associated with joint flexibility, comfort and function. Despite this, there are no studies yet on healthy volunteers complaining the symptoms of rheumatologic pathologies, without being ill. Here we performed a clinical trial on 154 subjects complaining functional discomfort associated to joints and muscles disorders. The principal objective was to test Kritech efficacy in reducing these symptoms. Subjects were split in two groups, with one receiving Kritech and the second one the placebo for 12 weeks.

Conditions

• Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Kritech administration	300mg/day (1 capsule) during 12 weeks; oral ingestion
OTHER	Placebo adminstration	1 placebo capsule per day during 12 weeks; oral ingestion

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2014-12-17
• Last updated: 2014-12-17

Locations

1 site across 1 country: France