Safety and Tolerability of Krill Powder Supplement in Slightly Overweight People With Moderately Elevated Blood Pressure

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03112083
• Date of registration: 27/03/2017
• Prospective Registration: No
• Primary sponsor: Olympic Seafood AS
• Public title: Safety and Tolerability of Krill Powder Supplement in Slightly Overweight People With Moderately Elevated Blood Pressure
• Scientific 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
• Date of first enrolment: October 6, 2015
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03112083
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Finland

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adverse Drug Event

Side Effects of Drugs

Intervention(s)

Dietary Supplement: Nutritional counseling A

Dietary Supplement: Nutritional counselling B

Primary Outcome(s)

Change in Adverse events [Time Frame: Screening, baseline, day 28, day 56]

Secondary Outcome(s)

Change in Diastolic blood pressure [Time Frame: Screening, baseline, day 28, day 56]

Type of adverse event [Time Frame: Screening, baseline, day 28, day 56]

Change in Aspartate transaminase (AST) [Time Frame: Screening, baseline, day 28, day 56]

Change in gamma glutamyl transferase [Time Frame: Screening, baseline, day 28, day 56]

Change in Alanine transaminase (ALT) [Time Frame: Screening, baseline, day 28, day 56]

Change in creatinine [Time Frame: Screening, baseline, day 28, day 56]

Change in blood count [Time Frame: Screening, baseline, day 28, day 56]

Change in High density lipoproteine (HDL)-cholesterol [Time Frame: Screening, baseline, day 28, day 56]

Change in Low density lipoproteine (LDL)-cholesterol [Time Frame: Screening, baseline, day 28, day 56]

Change in Thyroid stimulating hormone (TSH) [Time Frame: Screening, baseline, day 28, day 56]

Change in thyrotropin [Time Frame: Screening, baseline, day 28, day 56]

Change in blood glucose [Time Frame: Screening, baseline, day 28, day 56]

Change in Systolic blood pressure [Time Frame: Screening, baseline, day 28, day 56]

Change in total cholesterol [Time Frame: Screening, baseline, day 28, day 56]

Change in Triglycerides [Time Frame: Screening, baseline, day 28, day 56]

Secondary ID(s)

OP001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors