“This is the biggest study ever done on omega 3s and triglycerides. For everybody who asks the question of why there is not enough science about krill, we can point to this study,” said Matts Johansen, CEO of AkerBiomarine. Aker, which is based in Oslo, Norway, is a vertically integrated krill supplier that brings in about 70% of the world’s harvest of krill via a dedicated fishing fleet that operates out of Montevideo, Uruguay. Aker processes its krill oil ingredients at a plant in Houston.
The new study Johansen is pointing to is a new statistical analysis of data from earlier studies done with a krill oil ingredient that was being developed as a drug. The earlier studies had shown good results but also an unexpectedly high placebo effect. The authors of this new study said the data of the phase 3 trials were pooled and analyzed via a statistical plan that had been finalized before the initial results of the trials came in.
The study was published recently in the journal Cardiology. It was the work of a team led by Dr Dariush Mozaffarian, MD, of Tufts University in Boston.
Studies done in patients with severe hyperlipidemia
The two earlier trials together had enrolled more that 500 patients and were conducted from early 2018 to early 2020. The researchers were looking at the effects of a novel krill oil formulation that included both omega-3s in phospholipid form as well as in free fatty acid form.
They recruited their study populations from patients whose fasting TG levels ranged from 500 to 1500 mg/dL, with or without stable treatment with statins, fibrates, or other agents to lower cholesterol levels. The main outcome was the reduction in blood trigylceride levels at 12 weeks, with persistence at 26 weeks as a secondary measure. The original studies randomized the subjects at a 2.5:1 ration in favor of the krill oil intervention.
The researchers concluded that the pooled results argued strongly in favor of the krill oil intervention, which was safe and well tolerated.
“The pooled results of 2 large trials among patients with severe hypertriglyceridemia show that ω-3–PL/FFA, a novel, krill oil–derived mixture of ω-3, reduced TG levels at 12 and 26 weeks and increased the proportion of patients with TG levels of less than 500 mg/dL,” they wrote.
Aker exec: Study adds to research for sector
Katrina Handeland, Research & Development Director for Human Health and Nutrition, Aker BioMarine, said this new study is a significant addition to the research that has already been done on krill oil as a dietary ingredient, studies which often featured smaller subject populations of different makeup.
“These results help strengthen what we already know about the effects of krill oil on heart health from over a decade of doing research. The fact that these two studies, which were pooled together into one big study, were conducted in a patient population that we hadn’t studied previously, and found comparable results to our previous research, is confirmation about krill oil’s effects on heart health,” she said.
“In 2014 we conducted a clinical trial in participants who only had borderline high and high fasting serum triglyceride levels. This also showed significantly reduced triglyceride levels after krill oil supplementation versus placebo, without any increases in LDL cholesterol or other CVD risk markers. Taken together, the totality of evidence suggests that using krill oil helps prevent later cardiovascular disease, although such a prevention trial has not been conducted as it would have to be extremely large, take many years, and be very expensive in order to be done right,” she added.
Bioavailability claims supported?
Krill oil as an ingredient has less EPA and DHA per gram than does fish oil, and that difference is even greater when comparing it to the more concentrated forms of fish oil in the market, which includes those that have been approved as drugs like Lovaza. The developers of krill oil ingredients claim this difference is ameliorated by the greater bioavailability provided by the phospholipid form in which the omega-3s are bound in krill oil (free fatty acid forms are sail to have greater uptake, too).
Noted omega-3s researcher William S. Harris, PhD, of the Fatty Acid Research Institute, said there might be some support for this notion within the data of this most recent study.
“To get a 15% reduction of triglycerides with only 1.2 grams of omega-3s in a 4-gram dosage is pretty impressive. It’s certainly not news that omega-3s lower triglycerides, but what may be the news here is that a fairly low dose in this form can have this effect,” he said.
JAMA Netw Open. 2022;5(1):e2141898. doi:10.1001/jamanetworkopen.2021.41898
Effectiveness of a Novel ω-3 Krill Oil Agent in Patients With Severe Hypertriglyceridemia: A Randomized Clinical Trial
Authors: Mozaffarian D, et al