UNIQUE CHEMISTRY GIVES OTHER BIOMEDICAL EFFECTS
The oil is rich in the omega-3 fatty acids EPA, DHA and SDA bound as wax esters (>85%), and has as such a different composition than edible oils derived from e.g. fish and krill. The unique composition of Calanus® Oil implies that it is digested differently from other omega-3 products, which may explain its very pronounced effects on important metabolic parameters. Further elucidation of the biomedical mechanisms by which Calanus® Oil provides its effects is a key subject of the continuing research and development efforts of Calanus AS. During the past few years, several PhD students have studied the biomedical impact of Calanus® Oil, using a mouse model of obesity, showing local adipose tissue inflammation and insulin resistance.. The model is developed by feeding mice a high fat diet (HFD) to induce metabolic disturbances typically found among humans with life style disorders. Surprising and compelling results show that a small inclusion of Calanus® Oil in the HFD reduces HFD-induced abdominal fat deposition, adipose tissue inflammation and hepatic steatosis, along with increased glucose tolerance and increased aerobic capacity (Höper et al. 2013). In a follw-up publicationthese authors confirmed the above results, and demonstrated that the bioactive substances in Calanus® Oil was connected to its wax ester components (Höper et al. 2014). EPA and DHA from fish oil affected these parameters to a lesser extent. The beneficial effects of Calanus® Oil were obtained regardless of whether the supplementation was started before or after the onset of obesity and glucose intolerance.
PRECLINICAL STUDIES SHOWS CARDIOVASCULAR BENEFITS
Studies focusing on the cardiovascular system demonstrated that dietary supplementation with Calanus® Oil lowered plaque-formation in the aorta and aortic arch by 35% (Eilertsen et al. 2012). Furthermore, Calanus® Oil supplementation significantly attenuated angiotensin-induced hypertension in obese mice (Salma et al. 2016). Finally, in a more recent study on obese mice it was shown that dietary supplementation with Calanus® Oil prevented the impairment in myocardial glucose oxidation capacity, which is otherwise seen in obesity. Of note, the improvement in glucose oxidation capacity in response to Calanus® Oil supplementation was equal to that obtained by administration of the glucagon-like peptide-1 (GLP-1) analogue, exenatide, which is approved as adjunctive therapy to improve glycemic control in Type 2 diabetic (T2DM) patients (Jansen & Larsen, 2017).
HUMAN CLINICAL TRIALS
Human clinical studies using Calanus® Oil as a dietary supplement have been conducted, with the objective to confirm safety and bioavailability . A randomized, double-blinded, placebo-controlled clinical trial was conducted whereby 64 subjects consumed 2 g Calanus® Oil in capsule form daily for one year. The results confirmed that there were no effects on Calanus® Oil treatment on any of the safety parameters measured, meaning that the oil could be consumed with no adverse effects in the dose tested over one year (Tande et al. 2016). In a randomized, two-period crossover study 18 healthy adults consumed either Calanus® Oil or Lovaza® with equal doses of EPA and DHA. There were no differences in the blood plasma content of EPA+ DHA in response to treatment (Cook et al. 2016). The data demonstrated that Calanus® Oil, a novel wax ester rich marine oil, is a very suitable alternative source for EPA and DHA for human consumption.
R&D IS ESSENTIAL FOR REGULATORY APPROVALS
The research carried out with Calanus® Oil so far forms, together with other documentation, the basis for dossiers necessary for regulatory approval. This documentation is available to our B2B-customers. The product is currently sold to business customers in Norway and the USA, where large and rapidly growing consumer customer bases are already established. As Calanus® Oil is about the be approved in several countries including the EU, Calanus AS will be launching the product to new business customers and countries going forward, in concert with the Company’ planned increase in supply capability.
PILOT STUDIES, ONGOING AND FUTURE CLINICAL TRIALS
Several human clinical trials with Calanus® Oil are ongoing. These trials are partly due to requests from medical research groups to clinically test the product based on its proven safety and very interesting biomedical results, and partly due to the ambition of Calanus AS to elucidate how the company shall invest in more comprehensive clinical documentation with the objective to apply for approval of health claims in the future. Recently, a large clinical trial in children diagnosed with cognitive stress was initiated (“ADHD and Nutrition: The influence of Omega-3 on ADHD related symptoms.”(ClinicalTrials.gov Identifier: NCT02986672) at the University Hospital North-Norway, UNN). Promising results have already been obtained in clinical pilot studies that have been conducted or are ongoing, e.g. in groups of persons with IBS and impaired glucose metabolism. Possible new clinical trials, in parallel with further mechanistic studies, are being discussed with collaborative partners in Norway and internationally. An obvious area that we currently explore further is metabolic syndrome, a collective term for a cluster of risk factors for type 2 diabetes and heart disease, caused by visceral/abdominal obesity (e.g. glucose intolerance, dyslipidemia, fatty liver and hypertension). Download the full list of publications here.
Calanus As wish to thank all its scientific collaboration partners, pivotal to the company’s R&D-activities, including but not limited to research groups at UiT The Arctic University of Norway and the University Hospital North-Norway (UNN). The Research Council of Norway, Innovation Norway and MABIT are acknowledged for their financial support to our continuing research efforts.