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 Background Krill 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....
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| Format: | Article |
| Language: | English |
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BMC
2018-12-01
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| Series: | Lipids in Health and Disease |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12944-018-0935-x |
| _version_ | 1819112941741408256 |
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| author | Essi S. Sarkkinen Markku J. Savolainen Jyrki Taurio Tuuli Marvola Inge Bruheim |
| author_facet | Essi S. Sarkkinen Markku J. Savolainen Jyrki Taurio Tuuli Marvola Inge Bruheim |
| author_sort | Essi S. Sarkkinen |
| collection | DOAJ |
| description | Abstract Background Krill 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. Methods The 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. Results There 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. Conclusions The 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 registration ClinicalTrials.gov, NCT03112083, retrospectively registered. |
| first_indexed | 2024-12-22T04:21:31Z |
| format | Article |
| id | doaj.art-77c86312b19941adb8258b4a8a72326b |
| institution | Directory Open Access Journal |
| issn | 1476-511X |
| language | English |
| last_indexed | 2024-12-22T04:21:31Z |
| publishDate | 2018-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Lipids in Health and Disease |
| spelling | doaj.art-77c86312b19941adb8258b4a8a72326b2022-12-21T18:39:15ZengBMCLipids in Health and Disease1476-511X2018-12-011711910.1186/s12944-018-0935-xProspective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressureEssi S. Sarkkinen0Markku J. Savolainen1Jyrki Taurio2Tuuli Marvola3Inge Bruheim4Food and Nutrition, Oy Medfiles Ltd (CRO)Research Unit of Internal Medicine, Medical Research Center Oulu, Oulu University Hospital and University of OuluDepartment of Internal Medicine, University of Tampere and FinnMedi OyOy Medfiles Ltd (CRO)Rimfrost ASAbstract Background Krill 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. Methods The 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. Results There 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. Conclusions The 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 registration ClinicalTrials.gov, NCT03112083, retrospectively registered.http://link.springer.com/article/10.1186/s12944-018-0935-xKrill powderKrill oilSafetyTolerabilityAdverse eventOmega-3 fatty acids |
| spellingShingle | Essi S. Sarkkinen Markku J. Savolainen Jyrki Taurio Tuuli Marvola Inge Bruheim Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure Lipids in Health and Disease Krill powder Krill oil Safety Tolerability Adverse event Omega-3 fatty acids |
| title | Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure |
| title_full | Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure |
| title_fullStr | Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure |
| title_full_unstemmed | Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure |
| title_short | Prospective, randomized, double-blinded, placebo-controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure |
| title_sort | prospective randomized double blinded placebo controlled study on safety and tolerability of the krill powder product in overweight subjects with moderately elevated blood pressure |
| topic | Krill powder Krill oil Safety Tolerability Adverse event Omega-3 fatty acids |
| url | http://link.springer.com/article/10.1186/s12944-018-0935-x |
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