The study, conducted in conjunction with Aker BioMarine and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) at multiple study sites across Australia, will explore the supplement's impact on knee pain in adults with mild to moderate osteoarthritis of the knee.
Swisse is looking to recruit 234 more participants, both male and female, between the ages of 40 to 65 by the end of January next year, whereupon the trial will commence proper.
Each participant will take either a placebo or four 1,000mg capsules of Ultiboost High Strength Deep Sea Krill Oil (4g altogether) every day for about half a year, and the study will likely conclude by August 2019.
Krill concentration
Julie Romanin, Swisse's clinical trials manager, told NutraIngredients-Asia: "We obtain Superba BOOST from Aker BioMarine for our supplement, and we're using it in the trial because it has higher levels of EPA and DHA, compared to the earlier Superba product.
"It also contains astaxanthin, which acts as a natural preservative and anti-inflammatory ingredient. Together with the omega-3 fatty acids, it is meant to protect and improve joint and bone health. It comes in a soft capsule format, each containing 1,000mg of krill oil, so you would need to have no concerns about swallowing."
Aker BioMarine first launched Superba BOOST, its first krill concentrate, two years ago. Made with its own krill oil from Antarctica, the product was formulated with a higher concentration of phospholipids and omega-3 fatty acids than its previous iteration, simply called Superba2.
It also received Novel Foods Approval for extended use levels in April 2016, making it the only standard krill oil in the EU whose daily recommended dosage was permitted to exceed 250mg of EPA / DHA — and go up to 3,000mg.
The maximum allowable recommended daily dosage has since increased, with the each participant in the study's treatment group to ingest 4,000mg of Superba BOOST a day.
Clinical confidence
"Other studies have already been done on krill oil, and we want to provide more clinical evidence on its efficacy and usefulness for bone and joint health benefits. This is a large study, and we're very excited about it — we're confident it will further attest to the benefits of krill oil," Romanin added.
According to the Australian Bureau of Statistics 2014 — 2015 National Health Survey, osteoarthritis is the most common type of arthritis in Australia, afflicting 9% of the population (nearly 2.2 million people) and resulting in healthcare costs exceeding A$2.1bn in 2015.
This is the second clinical trial conducted under the strategic research agreement between CSIRO and Swisse, signed in 2016.
Romanin said, "We already have a trial in progress for our High Strength Cranberry Capsule for UTIs, which has been underway for 12 months. We are targeting women aged 18 to 65 with documented recurrent UTIs — at least two within the last six months or three within the last 12 months.
"The primary objective is to investigate the effectiveness of our capsule on the incidence of culture-confirmed UTIs in women with a history of recurrent UTIs over a six-month intervention period."