Swisse eyes exclusive therapeutic knee health claims for krill oil product following positive RCT findings

The product, known as Swisse Ultiboost High Strength Deep Sea Krill Oil, was recently tested in a six-month double-blind, randomised, placebo-controlled, multicenter trial involving 235 adults between 40 and 65 years old and were suffering from mild to moderate knee osteoarthritis.

Findings of the study were published in The American Journal of Clinical Nutrition​, ​where it was shown that the supplementation of krill oil has improved knee pain, stiffness and physical function.

During the trial, the intervention group took in four capsules – equivalent to 0.88g of EPA (0.60g) and DHA (0.28g) and 0.45mg of astaxanthin per day.

Using the WOMAC index which measures knee pain and stiffness, it was found that at the sixth month of the study, the intervention group saw a reduction of 17.8 units, while the placebo group also had a reduction of 12.6 units.

Participants with the greatest level of inflammation at baseline also reported greater improvements in knee pain.

Following the positive findings, Swisse is intending to apply a new set of therapeutic claims on knee pain for the product under the assessed listed (AUST-L(A)) medicines pathway, Brad Sanderson, Translational Science & Human Studies at H&H Research told NutraIngredients-Asia. ​

Under the AUST-L(A) pathway, the products’ therapeutic claims are assessed for efficacy before they are approved to go on sale.

The pursuit of the AUST-L(A) status will allow the product to make stronger and specific claims around knee pain, Sanderson said. Currently, the product claims to support heart, brain, and eye health and is easily absorbed.

“Under the AUST-L listings, we tend to be able to make mild claims and statements about the products’ effects. ​

“Whereas for the AUST-L(A), given that we have tested this in mild to moderate osteoarthritis patients, we are able to talk about the impact on individuals who are suffering a level of progression of osteoarthritis.”​

Aside from stronger claims, the AUST-L(A) pathway also provides a five-year protection for new clinical trial information​ that a sponsor has submitted in support in an application, provided that the information was not previously available.

“We hope with this pathway, it will help to ensure that we can build exclusivity around the claim set for the product.​

“And what we hope that can then do is to represent a really solid return on the investment for the research conducted,”​ Sanderson said.

Approval timeline​

Asked the timeline in earning the AUST-L(A) status, Sanderson said it would require about six months for the submission to go through.

“We’re learning the process as we go through this. But we know it’s approximately about a six-month process from submission to go through. ​

“We definitely be expecting those that approval later in the year as part of this process.”​

A search on the Australian Register of Therapeutic Goods (ARTG) shows that there are currently two products approved as AUST-L(A).

They are Caruso’s Prostate Eze Max by Caruso’s Natural Health and Hydralyte Orange Flavoured Effervescent Electrolyte Tablets by Care Pharmaceuticals.

The former makes the claim “for the relief of nocturia (night-time urinary frequency) associated with medically diagnosed benign prostatic hypertrophy.”

The latter makes a number of claims, such as “for the management/prevention/alleviation of dehydration due to gastroenteritis, including traveller's diarrhoea.”

Krill oil mechanisms ​

It is suggested that krill oil has helped to reduce knee pain in mild to moderate knee osteoarthritis patients via anti-inflammatory mechanisms.

Krill oil contains EPA, DHA, and astaxanthin.

“It is worth mentioning it may not just be based on the anti-inflammatory pathways, and that krill oil contribute to pain reduction through non-inflammatory mechanisms as well.​

“So DHA, for example, has been shown to positively impact on cartilage degradation in animal arthritis models,” ​Sanderson said.

On the other hand, other commonly used joint health ingredients such as glucosamine and chondroitin typically focus more on slowing the progression of the cartilage destruction, he said.

In contrast to fish oil, which comes in the form of triglycerides, krill oil, with its phospholipid structure, is also said to remain in the blood circulation longer than triglycerides.​

This in turn allows it to be taken up by the body’s tissues and subsequently stored or metabolised.

Building evidence​

Swisse hopes to expand its own datasets to support the claims of its products, and this particular research is one such example.

The trial was commissioned by Swisse and conducted by Australia’s national science agency Commonwealth Scientific and Industrial Research Organisation (CSIRO). The krill oil used in the Swisse’s product was supplied by Aker BioMarine.

“Swiss has for a long time identified that growing need by the industry to grow the research around our products and that commitment to conduct research.​

“We obviously leverage existing research, but we also are committed to building our own datasets in order to support the evidence base for our products and that will definitely continue to be a critical part of our business as we move into the future.​

“The partnership with Aker to build the clinical dataset for Superba Boost provided a unique opportunity for Swiss and Aker to come to engage in high quality research with the intention that we could ultimately use that data to pursue the relatively unused AUST-L(A) regulatory pathway.”​

Innovation opportunities ​

Asked the opportunities for new product innovation in the knee osteoarthritis supplement space, Sanderson pointed out that the dosage format could be an area of interest.

While the main consumer group of such products are the older population who are more aligned with the idea of classic formats such as tablets and capsules, he noticed that novel formats are coming to the forefront.

“We know that other areas of the market are starting to engage with these other sensorial formats, whether they be gummies, powders, fast melts, all these sorts of exciting formats that are coming to the fore and offering a differentiated opportunity.​

“So certainly, format could be an interesting place in future into the future.”​

Nonetheless, he said that the company would focus more on the opportunities backed by new scientific findings instead of merely seeking to fill existing market gaps.

“I want to bring it back to the fact that we're probably less focused on the market gaps and more focused on the opportunity that the clinical trial represents,” ​he said.