Investigating the Potential for Marigot's Nutrition Supplement to Improve Symptoms and Physical Function in Those With Mild to Moderate Knee Osteoarthritis (KOA) Versus the Current Market Leader (Glucosamine Sulphate)

This project will be a double blinded randomized cross-over control (pilot) trial that will investigate whether the combination of Aquamin (a calcium-rich marine multi-mineral) and a polyphenol-rich pine bark extract (Enzogenol), when taken as a food supplement for 3 months (12 weeks) has comparable or superior benefits to glucosamine sulphate in patients with painful knee osteoarthritis (KOA). From here on in we refer to Aquamin's combination product as Aquamin-plus. The main outcome measure is a reduction in pain (WOMAC index) and improve physical function (6MWD and TUG).

The hypothesis of the study is that the consumption of Aquamin-plus for a period of 3 months will have comparable or superior effects on to glucosamine sulphate in reducing pain and improving physical function in individuals with KOA.

According to the Food and Drug Administration et al. osteoarthritis (OA) can be defined as a serious disease or condition because, among other aspects, it is "...associated with morbidity that has substantial impact on day-to-day functioning..." . Furthermore, the current Osteoarthritis Research Society International (OARSI) definition of OA has been proposed as, "OA is a disorder involving movable joints characterized by cell stress and extracellular matrix degradation initiated by micro- and macro-injury that activates maladaptive repair responses including pro-inflammatory pathways of innate immunity. The disease manifests first as a molecular derangement (abnormal joint tissue metabolism) followed by anatomic, and/or physiologic derangements (characterized by cartilage degradation, bone remodeling, osteophyte formation, joint inflammation and loss of normal joint function), that can culminate in illness"

The condition can be characterized as a branch of rheumatic disease that is a progressive condition of synovial joints and is caused by the failure of a joint to repair following damage. This damage may have been caused by stresses due to an abnormality in the articular cartilage, subchondral bone, ligaments, menisci, periarticular muscles, peripheral nerves or synovium. Failure of these normal biological processes leads to breakdown of cartilage and bone and is characterized by symptoms of pain, stiffness, functional disability and can and lead to negative effects on fatigue, mood, sleep and overall quality of life. OA has the highest frequency of all rheumatic diseases and is one of the most prevalent chronic diseases in the modern day. According to the Global Burden of Disease (GBD) study, progressive ageing of the population could make OA the ninth cause of disability-adjusted life years (DALYs) in developed countries by the year 2020, with KOA accounting for 83% of the total OA burden.

Investigations into the heritability of OA have identified some interesting results. In a British twin cohort, the genetic contribution to radiographically defined hip and KOA was estimated to 39-65% in women with a Danish twin studies finding similar variance in hip arthroplasty due to OA (47%) but only 18% for knee arthroplasty due to OA. However, more recent data from a larger cohort (n = 9058) showed a heritability of 73% and 45% in hip and knee arthroplasty, respectively. Interestingly, identified that while hip OA associated arthroplasty remains highly heritable regardless of environmental factors, while the genetic component of KOA (for arthroplasty) was significantly modifiable with increasing BMI. These data show the requirement for clinical interventions to focus on symptomatic KOA, particularly considering the exponentially increasing BMI and obesity in the western world.