Clinical trial NCT02318875: Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders
Official title: Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Inflammation
swell
pain
functional impairment
stiffness
Lead sponsor: Vivatech
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: SMFA score
timeFrame: 12 weeks
Secondary outcomes:
measure: SMFA " dysfunction index " and " bother index " subscores
timeFrame: 12 weeks
measure: MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire
timeFrame: 12 weeks
measure: Pain evaluated by EVA (Échelle Visuelle Analogique)
timeFrame: 12 weeks
measure: Clinical Global Impression (CGI scale)
timeFrame: 12 weeks
measure: Analgesics consumption
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN
Study officials:
affiliation: University Hospital Bordeaux, France
name: Nicholas Moore, Professor
role: PRINCIPAL_INVESTIGATOR
References: