Evidence map›Paper›PMID 30572894›Full record

Trial reportLipids in health and disease2018

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

Essi S Sarkkinen, Markku J Savolainen, Jyrki Taurio, Tuuli Marvola, Inge Bruheim

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Lipids in health and disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03112083 (Prospective, Randomized, Single-center, Double-blinded, Placebo-controlled Study on Safety and Tolerability of the Krill Powder Product in Slightly Obese Study Subjects With Moderately Elevated Blood Pressure), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03112083 nacompletednot on this map

Prospective, Randomized, Single-center, Double-blinded, Placebo-controlled Study on Safety and Tolerability of the Krill Powder Product in Slightly Obese Study Subjects With Moderately Elevated Blood Pressure

TypeinterventionalSponsorOlympic Seafood ASRan2015 to 2016Enrolled35ConditionsAdverse Drug Event, Side Effects of DrugsArmsNutritional counseling A, Nutritional counselling B
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Krill Oil Combined withFoods (Basel, Switzerland) · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Essi S SarkkinenFood and Nutrition, Oy Medfiles Ltd (CRO), P.O.Box 1450, 70701, Kuopio, Finland. essi.sarkkinen@medfiles.eu.ORCID http://orcid.org/0000-0001-8348-6007
Markku J SavolainenResearch Unit of Internal Medicine, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, P.O.Box 5000, 90014, Oulu, Finland.
Jyrki TaurioDepartment of Internal Medicine, University of Tampere and FinnMedi Oy, 33014, Tampere, Finland.
Tuuli MarvolaOy Medfiles Ltd (CRO), P.O.Box 1450, 70701, Kuopio, Finland.
Inge BruheimRimfrost AS, Skansekaia 3 C, Ålesund, 6002, Norway.
Medfiles (Finland) · FIOulu University Hospital · FIRimfrost (Norway) · NOTampere University · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

HypertensionOverweightAdultAgedAnimalsDietary SupplementsDocosahexaenoic AcidsDouble-Blind MethodEicosapentaenoic AcidEuphausiaceaFemaleHumansMaleMiddle AgedProspective StudiesSeafoodDocosahexaenoic AcidsEicosapentaenoic AcidAdverse eventDocosahexaenoic acidEicosapentaenoic acidKrill oilKrill powderOmega-3 fatty acidsSafetyTolerability

Identifiers

PMID30572894
PMCPMC6302457
OpenAlexW2905655181

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.