A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoarthritis (OA) is the most common kind of arthritis and primarily affects the large,
      weight bearing joints (including the knees, lower back, hips, neck and the feet) and the
      joints in the hands. OA results from the breakdown of cartilage in joints, leading to joint
      pain and damage. It affects about 8 million people in the United Kingdom and nearly 27
      million people in the United States, most of whom are over the age of 45.

      This study aim to determine if Aquamin (as AquaCal and AquaPT) affects molecules of
      inflammation in the blood of osteoarthritis and healthy subjects.
    

Detailed description: 
      Aquamin is a seaweed-derived mineral source, which is rich in calcium, magnesium and 74 other
      trace minerals including zinc, iron and selenium. It is produced from the red algae,
      Lithothamnion Calcareum, which is found in just three locations in the world, including the
      south-west coast of Ireland and Iceland. During a five-year life span, these algae absorb
      essential minerals from the sea - this gives Aquamin its unique multimineral content. The
      algae then break down naturally and settle on the sea bed. These calcified skeletal remains
      are harvested, washed, dried and milled and provided in a capsule formulation. AquaCal is the
      capsule form of Aquamin. AquaPT contains green tea and pine bark extract.

      Osteoarthritis (OA) is the most common kind of arthritis. OA is called degenerative
      arthritis, is a disease that results from the breakdown of cartilage in joints, leading to
      joint pain and damage. OA is very variable and there are lots of different types affecting
      different joints. This degenerative disease primarily affects the large, weight bearing
      joints (including the knees, lower back, hips, neck and the feet) and the joints in the
      hands. In OA, the disease begins with the degeneration of the cushion of cartilage between
      the joints. As it degrades, the synovium and the ends of the bones thicken, resulting in the
      pain and stiffness associated with arthritis. The progressive cartilage deterioration is
      followed by "hardening of the joints" due to calcification and bone spur formation. Treatment
      generally involves a combination of exercise, lifestyle modification and analgesics. If pain
      becomes debilitating joint replacement surgery may be used to improve the quality of life.

      Symptoms of Osteoarthritis include early morning joint stiffness and pain, loss or
      restriction of joint mobility, pain that is worse after use, stiffness after periods of rest,
      creaking/cracking of joints after movement (also known as crepitus), tenderness and swelling
      in certain areas, restricted mobility, pain in the joint before or during changes in the
      weather and deformity of the joints.

      Osteoarthritis is the leading cause of chronic disability in the United States.[1] It affects
      about 8 million people in the United Kingdom and nearly 27 million people in the United
      States, most of whom are over the age of 45. A number of studies have shown that there is a
      greater prevalence of the disease between siblings and especially identical twins, indicating
      a hereditary basis [2]. Up to 60% of OA cases are thought to result from genetic factors.
      Other factors causing OA are congenital disorders of joints, diabetes, inflammatory diseases
      and all chronic forms of arthritis. In addition, injury to joints as a result of an accident,
      septic arthritis, Marfan syndrome, obesity, ligamentous deterioration or instability may also
      be factors.

      Current anti-inflammatory treatments for OA while providing some relief from symptoms are
      suboptimal and the side effects associated with these treatments; in particular the COX-2
      specific NSAID's are becoming increasingly recognized [3,4]. As a result of this, use of
      alternative treatments and complementary medicines are gaining popularity among OA sufferers.

      In a previous study, where osteoarthritis subjects were treated with Aquamin, there was a
      significant improvement in the WOMAC scores for pain, stiffness, activity and composite
      scores over the course of the 12-week treatment, in comparison to subjects in the Placebo
      group[5].

      Aquamin is composed of multiple minerals and the 'active ingredient' for the complex is
      difficult to determine. A number of the minerals in Aquamin may have anti-inflammatory and
      anti-oxidant properties which might directly and/or indirectly influence the efficacy of this
      unique complex [7,8,9]. While the prominent mineral present in Aquamin is calcium (dosage =
      80% Ca U.S RDA), its role in joint health is unclear. Magnesium however, was given at the
      daily dosage providing 14% (male) to 18% (female) U.S. RDA [6] and over the course of this
      study, this increased consumption of magnesium may have influenced OA symptoms by affecting
      the utilization of calcium or by potentially reducing inflammation around the affected joint.
      Both manganese and selenium were given at the daily dosage providing up to 16% and 4% of
      their RDA respectfully. Both of these trace minerals have been reported to reduce the
      appearance of osteoarthritic lesions and reduce the severity of symptoms in OA [8,9].
    

Intervention name(s): AquaCal; AquaPT
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.
The daily dose of 4 capsules of AquaCal provide 800mg calcium, (the EU RDA for calcium) and 74 mgs Magnesium (EU RDA 375mg).; AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.
The daily dose of 4 capsules of AquaPT provides 720mg calcium, 200mgs green tea (polyphenols) and 50 mgs pine bark extract.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Osteoarthritis