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

NCT ID: NCT02318875

Last Updated: 2014-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

Brief 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

Keywords

Inflammation; swell; pain; functional impairment; stiffness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Kritech group

Subjects take 1 Kritech capsule per day (dose of 300mg)

Group Type: EXPERIMENTAL

Kritech administration

Intervention Type: DIETARY_SUPPLEMENT

300mg/day (1 capsule) during 12 weeks; oral ingestion

Placebo group

Subjects take 1 placebo capsule per day

Group Type: PLACEBO_COMPARATOR

Placebo adminstration

Intervention Type: OTHER

1 placebo capsule per day during 12 weeks; oral ingestion

Interventions

Kritech administration

300mg/day (1 capsule) during 12 weeks; oral ingestion

Intervention Type: DIETARY_SUPPLEMENT

Placebo adminstration

1 placebo capsule per day during 12 weeks; oral ingestion

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vivatech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Moore, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN

Bordeaux, , France

Countries

France

Other Identifiers

2011-A00320-41/1

Identifier Type: -

Identifier Source: org_study_id