Adverse Drug Event Clinical Trial
Official title:
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
Verified date | April 2017 |
Source | Olympic Seafood AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 17, 2016 |
Est. primary completion date | June 17, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18-65 years - Slightly obese female and male subjects (BMI between 25-30 kg/ m2) - Mildly or moderately elevated blood pressure (RR systolic 130-159/ diastolic under 99) - Signed written informed consent Exclusion Criteria: - Medication potential to affect serum lipids (lipid-lowering drugs) - Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome) - Any untreated medical condition affecting absorption of fat - Type 1 and 2 diabetes - Cancer or other malignant disease within the past five years - Periodical hormone replacement therapy - High intake of oily fish (>2 times per week as a principal meal) (i.e. salmon, herring, sardines, mackerel, vendace) - Smoking - Alcohol consumption >15 doses per week - Pregnant, lactating or wish to become pregnant - Hypersensitivity to fish or any of the components of the test products - Regular use (> 3 times per week) of n-3 or other fatty acid supplements, plant sterols or fiber supplements 4 weeks before randomization - Lack of suitability for participation in the trial, for any medical reason, as judged by the PI |
Country | Name | City | State |
---|---|---|---|
Finland | Oy Medfiles Ltd | Kuopio |
Lead Sponsor | Collaborator |
---|---|
Olympic Seafood AS |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Adverse events | Total number of reported adverse events | Screening, baseline, day 28, day 56 | |
Secondary | 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 | Screening, baseline, day 28, day 56 | |
Secondary | 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) | Screening, baseline, day 28, day 56 | |
Secondary | 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) | Screening, baseline, day 28, day 56 | |
Secondary | Change in thyrotropin | Regular safety parameters from the blood including mean and median variables of blood thyrotropin | Screening, baseline, day 28, day 56 | |
Secondary | Change in Alanine transaminase (ALT) | Regular safety parameters from the blood including mean and median variables of blood Alanine transaminase (ALAT) | Screening, baseline, day 28, day 56 | |
Secondary | Change in Aspartate transaminase (AST) | Regular safety parameters from the blood including mean and median variables of blood Aspartate transaminase (ASAT) | Screening, baseline, day 28, day 56 | |
Secondary | Change in blood glucose | Regular safety parameters from the blood including mean and median variables of blood glucose | Screening, baseline, day 28, day 56 | |
Secondary | Change in gamma glutamyl transferase | Regular safety parameters from the blood including mean and median variables of gamma glutamyl transferase | Screening, baseline, day 28, day 56 | |
Secondary | Change in creatinine | Regular safety parameters from the blood including mean and median variables of creatinine | Screening, baseline, day 28, day 56 | |
Secondary | Change in blood count | Regular safety parameters from the blood including mean and median variables of blood count | Screening, baseline, day 28, day 56 | |
Secondary | Change in Thyroid stimulating hormone (TSH) | Regular safety parameters from the blood including mean and median variables of Thyroid stimulating hormone (TSH) | Screening, baseline, day 28, day 56 | |
Secondary | Change in Triglycerides | Mean concentration of serum total triglycerides and mean change (0 vs 8 wk) in serum total and lipoprotein lipids | Screening, baseline, day 28, day 56 | |
Secondary | 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 | Screening, baseline, day 28, day 56 | |
Secondary | 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 | Screening, baseline, day 28, day 56 | |
Secondary | 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 | Screening, baseline, day 28, day 56 |
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