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

A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Krill Oil

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Cetero Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Cetero Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in fasting serum triglycerides	Baseline (Day 1) and at Day 85

Secondary Outcome Measures

Outcome Measure	Time Frame
Omega-3 index	At Days 1, 42, and 85

Collaborators and Investigators

• Sponsor: Aker Biomarine Antarctic AS

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (ESTIMATE): August 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 21, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Maintenance of normal blood triglyceride levels
• Other Study ID Numbers: CHSI 1102-16