Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure

Abstract

BackgroundKrill powder is rich in bioactive ingredients such as eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), phospholipids, protein and astaxanthin. Containing dominantly EPA, it is considered to be effective in lowering lipids, foremost serum triglycerides and LDL cholesterol. Krill-derived protein hydrolysates/peptides may have positive effect on blood pressure and astaxanthin has anti-oxidative and anti-inflammatory properties. Thus, krill powder has a lot of potential in improving lipid and metabolic profile and reinforcing the activity of the antioxidant system. However, randomized clinical trials on krill powder are scarce and systematic data of krill meal on human safety is limited. Some of the earlier studies have reported several, non-serious adverse events, mostly related to gastrointestinal tract, but systematic sufficiently powered study on safety is lacking. The aim of this study was to collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.MethodsThe study was a randomised, double-blinded, placebo-controlled intervention study with 35 overweight subjects with mildly or moderately elevated blood pressure, who took 4 g krill oil powder or 4 g of placebo during an 8-week follow-up period. The study consisted of a pre-screening, screening, day 0 baseline (randomization visit) and three follow-up visits on days 14, 28 and 56. The reported adverse events in the groups were compared as primary endpoint and haematological safety parameters and changes in systolic and diastolic pressure and blood total and lipoprotein lipids were measured as secondary end points.ResultsThere were in total 80 reported adverse events during the follow-up; 50 in placebo and 30 in krill powder group. Gastrointestinal symptoms (flatulence, heartburn and diarrhea) were the most commonly reported among those probably related to the test products. No serious adverse events were reported. The mean value of all measured hematology variables remained within the reference values in all study subject and no significant changes were observed in blood pressure or lipid values.ConclusionsThe results seem to indicate that using krill powder as a source for EPA and DHA is safe in therapeutic dose and the risk of adverse events, let alone serious ones, is low.Trial registrationClinicalTrials.gov, NCT03112083, retrospectively registered.

Astaxanthin Influence on Health Outcomes of Adults at Risk of Metabolic Syndrome: A Systematic Review and Meta-Analysis

“…The included studies were published between 2009 and 2018. Two were conducted in Japan [ 26 , 27 ], and the rest were conducted in Iran [ 28 ], Finland [ 29 ], Korea [ 30 ], Australia [ 31 ], and Canada [ 32 ]. The included studies comprised 17 treatment arms with a total of 321 participants (185 participants in the AST arm and 136 participants in the control arm).…”

“…The sample sizes varied from 27 [ 30 ] to 63 [ 32 ]. The daily dosage of AST varied from 0.16 [ 29 ] to 20 mg [ 30 ]. Two studies reported outcomes in terms of different dosages of AST [ 26 , 27 ].…”

Krill Oil Combined with Bifidobacterium animalis subsp. lactis F1-7 Alleviates the Atherosclerosis of ApoE−/− Mice

“…It has been reported that its main components EPA and DHA play key roles in metabolic regulation [25]. In addition, KO also contains a dose of astaxanthin, which is believed to be responsible for the anti-inflammatory, antioxidant, analgesic, and lipid-lowering properties in vivo [26,27]. It has been found that KO improves intestinal flora structure and metabolites.…”

Krill Protein Hydrolysate Provides High Absorption Rate for All Essential Amino Acids—A Randomized Control Cross-Over Trial

“…Studies on krill protein for human consumption are very limited [30] and the AA profile after the ingestion of krill protein compared to other protein sources has not been studied previously in a human trial. The study revealed that all of the three protein sources significantly increased the total postprandial AA serum concentration at all timepoints between 20-120 min compared to CON.…”