Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides - Full Text View

Sponsor:	Aker Biomarine Antarctic AS
Information provided by:	Aker Biomarine Antarctic AS
ClinicalTrials.gov Identifier:	NCT01415388

Purpose

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.

Condition	Intervention
Healthy	Dietary Supplement: Krill Oil

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides

Further study details as provided by Aker Biomarine Antarctic AS:

Primary Outcome Measures:

Change in fasting serum triglycerides [ Time Frame: Baseline (Day 1) and at Day 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Omega-3 index [ Time Frame: At Days 1, 42, and 85 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2011
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: Superba(TM) Krill Oil

Eligibility

Ages Eligible for Study:	21 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415388

Contacts

Contact: Ellen Myers

636-757-7081

ellen.myers@cetero.com

Locations

United States, Missouri
Cetero Research	Recruiting
St. Charles, Missouri, United States, 63301
Principal Investigator: James C Freeman, MD, MT
United States, North Dakota
Cetero Research	Recruiting
Fargo, North Dakota, United States, 58104
Principal Investigator: Gregory M. Haugen, MD

Sponsors and Collaborators

Aker Biomarine Antarctic AS

More Information

No publications provided

Responsible Party:	Kjetil Berge, Ph.D., Aker BioMarine Antarctic AS
ClinicalTrials.gov Identifier:	NCT01415388 History of Changes
Other Study ID Numbers:	CHSI 1102-16
Study First Received:	August 10, 2011
Last Updated:	August 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Aker Biomarine Antarctic AS:

Maintenance of normal blood triglyceride levels

ClinicalTrials.gov processed this record on May 23, 2012