An interventional study of Nutritional counseling A and Nutritional counselling B in Adverse Drug Event and Side Effects of Drugs, sponsored by Olympic Seafood AS. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by Olympic Seafood AS · Not applicable, Interventional, and Other
The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.
The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56.
As a primary endpoint of the study, the total number of reported adverse events were compared in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of placebo for the 8-week follow-up period.
Krill powder is a food supplement rich in active ingredients such as fatty acids, phospholipids, protein and antioxidants like astaxanthin. It is considered to be more effective in lowering triglyceride values than fish oils and it may have positive effect on cholesterol values as well. Krill proteins 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 values and having other positive health effects on cardiovascular system. However, there haven't been many clinical studies done with krill powder and thus systematic data on human safety is limited.
The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.
The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56.
A total of 6 study visits were included. At pre-screening visit the study subjects were requested to sign pre-screening visit informed consent form. A structured interview on demographics (age, sex, ethnicity), previous and current diseases, current medication, alcohol and tobacco consumption and use of dietary supplements (especially fish oil and other n-3 fatty acid (FA) supplements, plant sterols and cholesterol lowering fiber supplements (guar gum, glucomannan, oat fiber etc.) and use of fish foods was carried out at the screening visit and replicated at the day 56 visit. Study included one test product: krill powder derived from antarctic krill (Euphausia Superba) (Rimfrost Pristine®, Rimfrost AS, PO box 234, 6099 Fosnavaag, Norway) and placebo product and both were given in capsule form, 4 capsules in the morning and 4 in the evening.
Nutritional counselling regarding the consumption of fish, omega-3 and -6 fatty acids, food supplements and investigational product for the duration of the study were given for the study subjects at the screening visit by a study nurse or registered dietitian and compliance was followed throughout the study. The subjects were advised to keep their medication, lifestyle, background diet and body weight constant during the study and deviation were recorded into the diary.
As a primary endpoint of the study, the total number of reported adverse events were compared in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of placebo for the 8-week follow-up period. Any unfavourable and unintended sign, symptom or medical complaint and worsening of a pre-existing condition was regarded as adverse event (AE). Study subjects kept diary for the whole duration of the study and were requested to write down all unfavourable symptoms and medical complaints not existing at baseline or significantly worsened from baseline situation. Completeness of diaries was checked at each study visit. All reported adverse events were recorded, coded and analysed carefully to determine severity, possible relation to study products, onset and outcome of the event. In addition, safety laboratory values, cholesterol and triglyceride values and blood pressure was measured.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 35 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Olympic Seafood AS is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Krill powder capsules, 4 g
Dietary Supplement: Nutritional counseling A
Placebo capsules, maize strach, 4 g
Dietary Supplement: Nutritional counselling B
Krill powder capsules
Placebo capsules
Change in Adverse events
Total number of reported adverse events
Time frame: Screening, baseline, day 28, day 56
Type of adverse event
Coding by MedDRA and reported with System organ class (SOC) and Prefered term (PT) levels, seriousness, severity, onset and causality of the reported adverse events
Time frame: Screening, baseline, day 28, day 56
Change in Systolic blood pressure
Mean and mean change (0 vs 8 wk) in systolic blood pressure recorded with 1 mmHg accuracy taken in the screening and during the intervention visits (three measurements are taken altogether and an average of last two measures is used in the analysis)
Time frame: Screening, baseline, day 28, day 56
Change in Diastolic blood pressure
Mean and mean change (0 vs 8 wk) in diastolic blood pressure recorded with 1 mmHg accuracy taken in the screening and during the intervention visits (three measurements are taken altogether and an average of last two measures is used in the analysis)
Time frame: Screening, baseline, day 28, day 56
Change in thyrotropin
Regular safety parameters from the blood including mean and median variables of blood thyrotropin
Time frame: Screening, baseline, day 28, day 56
Change in Alanine transaminase (ALT)
Regular safety parameters from the blood including mean and median variables of blood Alanine transaminase (ALAT)
Time frame: Screening, baseline, day 28, day 56
Change in Aspartate transaminase (AST)
Regular safety parameters from the blood including mean and median variables of blood Aspartate transaminase (ASAT)
Time frame: Screening, baseline, day 28, day 56
Change in blood glucose
Regular safety parameters from the blood including mean and median variables of blood glucose
Time frame: Screening, baseline, day 28, day 56
Change in gamma glutamyl transferase
Regular safety parameters from the blood including mean and median variables of gamma glutamyl transferase
Time frame: Screening, baseline, day 28, day 56
Change in creatinine
Regular safety parameters from the blood including mean and median variables of creatinine
Time frame: Screening, baseline, day 28, day 56
Change in blood count
Regular safety parameters from the blood including mean and median variables of blood count
Time frame: Screening, baseline, day 28, day 56
Change in Thyroid stimulating hormone (TSH)
Regular safety parameters from the blood including mean and median variables of Thyroid stimulating hormone (TSH)
Time frame: Screening, baseline, day 28, day 56
Change in Triglycerides
Mean concentration of serum total triglycerides and mean change (0 vs 8 wk) in serum total and lipoprotein lipids
Time frame: Screening, baseline, day 28, day 56
Change in total cholesterol
Mean concentration of total cholesterol during the 8-week intervention and mean change (0 vs 8 wk) in serum total and lipoprotein lipids
Time frame: Screening, baseline, day 28, day 56
Change in Low density lipoproteine (LDL)-cholesterol
Mean concentration of serum LDL-cholesterol during the 8-week intervention and mean change (0 vs 8 wk) in serum total and lipoprotein lipids
Time frame: Screening, baseline, day 28, day 56
Change in High density lipoproteine (HDL)-cholesterol
Mean concentration of serum HDL-cholesterol during the 8-week intervention and mean change (0 vs 8 wk) in serum total and lipoprotein lipids
Time frame: Screening, baseline, day 28, day 56
Plan to share: No
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Olympic Seafood AS