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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Dietary supplement: Kritech administration; Other: Placebo adminstration

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects;
• >18 years old;
• Complaining functional discomfort associated to joints and/or muscles disorders, motility disorders and/or initial SMFA score higher or equal to 15 ;
• Able to give a written or verbal informed consent,
• Affiliated or beneficiary of social security

Exclusion Criteria:

• IMC>30kg/m
• Acute or chronic, progressive joint disorders (arthrosis, rheumatoid arthritis, acute articular rheumatism) of first or second degree and correlated treatments;
• Subjects refusing of giving their written or verbal informed consent
• Subjects deprived of freedom following an administrative or judicial decision
• Participation to another clinical trial in the last four weeks;
• People who already participated to another research that comprises an exclusion period still ongoing at the time of inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kritech group; Subjects take 1 Kritech capsule per day (dose of 300mg)	Dietary supplement: Kritech administration; 300mg/day (1 capsule) during 12 weeks; oral ingestion
Placebo Comparator: Placebo group; Subjects take 1 placebo capsule per day	Other: Placebo adminstration; 1 placebo capsule per day during 12 weeks; oral ingestion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SMFA score	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
SMFA " dysfunction index " and " bother index " subscores	12 weeks
MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire	12 weeks
Pain evaluated by EVA (Échelle Visuelle Analogique)	12 weeks
Clinical Global Impression (CGI scale)	12 weeks
Analgesics consumption	12 weeks

Collaborators and Investigators

• Sponsor: Vivatech
• Investigators: Principal Investigator: Nicholas Moore, Professor, University Hospital Bordeaux, France

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Inflammation; pain; stiffness; functional impairment; swell
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases
• Other Study ID Numbers: 2011-A00320-41/1