Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides

NCT ID: NCT01415388

Last Updated: 2013-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Interventions

Krill Oil

4 Capsules twice daily providing 0 (placebo), 0.5, 1.0, 2.0, or 4.0 g krill oil/day for a period of 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Superba(TM) Krill Oil

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aker BioMarine Human Ingredients AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cetero Research

Saint Charles, Missouri, United States

Cetero Research

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

CHSI 1102-16

Identifier Type: -

Identifier Source: org_study_id