Clinical trial NCT01415388: Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides
Official title: A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Maintenance of normal blood triglyceride levels
Lead sponsor: Aker BioMarine Human Ingredients AS
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effect of 12 weeks of daily supplementation with Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects whose habitual fatty fish and seafood intake is low and who have borderline high or high fasting serum triglyceride levels.


Eligibility criteria: Inclusion Criteria(not limited to):

* General good health with no existing co-morbidities
* Body mass index (BMI) less than 35 kg/m²
* Borderline high or high fasting serum triglycerides
* Clinically normal findings for hematology, clinical chemistry, and urinalysis
* Be willing to maintain dietary habits and physical activity levels throughout the trial period (next 4 months)
* Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less

Exclusion Criteria (not limited to):

* Familial hypercholesterolemia or severely high total cholesterol levels
* History or presence of significant cardiovascular disease or co-morbidities
* Known allergy to crustaceans (shellfish)
* Bleeding disorders
* Disturbed absorption due to changes in the gastrointestinal tract
* Participation in a clinical trial with an investigational product within 30 days before screening
* Present or recent use (within 3 months of screening or the first screening visit, if applicable) of any medication which is a known lipid modifying agent or any dietary supplements that affect the level of blood cholesterol and triglycerides
* Current or recent diet, which in the opinion of the Investigator, deviates from a normal diet (e.g., vegetarians may be acceptable, vegans are not acceptable)
* Female patients that are pregnant or nursing or females of childbearing potential who are not on a method of birth control acceptable to the Investigator during treatment
* Patients with known coagulopathy or receiving anticoagulant therapy or co-morbidity that would interfere with the study results
* Frequency of fatty fish and/or seafood consumption is greater than twice per month
* Present or recent use of any long-chain omega-3 fatty acid supplement
* Peri-menopausal women or post-menopausal women taking hormone replacement therapy
* Patients who test positive for human immunodeficiency virus (HIV) or hepatitis B or C
* Systolic blood pressure greater than 159 mmHg or diastolic blood pressure greater than 99 mmHg or use of anti-hypertensive medication
* Diabetic subjects
* Staff of Cetero Research

Primary outcomes:
measure: Change in fasting serum triglycerides
timeFrame: Baseline (Day 1) and at Day 85
Secondary outcomes:
measure: Omega-3 index
timeFrame: At Days 1, 42, and 85
Other outcomes:
Locations:
city: St. Charles
country: United States
facility: Cetero Research
state: Missouri
city: Fargo
country: United States
facility: Cetero Research
state: North Dakota
Study officials:
References: