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

NCT01415388 | Completed DMC

• 1 other identifier: CHSI 1102-16
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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

Keywords

Maintenance of normal blood triglyceride levels

Outcome Measures

Primary Outcomes (1)

• Change in fasting serum triglycerides

  Baseline (Day 1) and at Day 85

Secondary Outcomes (1)

• Omega-3 index

  At Days 1, 42, and 85

Interventions

Krill Oil DIETARY_SUPPLEMENT

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

Also known as: Superba(TM) Krill Oil

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aker BioMarine Human Ingredients AS: lead

Study Sites (2)

Cetero Research

Saint Charles, Missouri, 63301, United States

Location

Cetero Research

Fargo, North Dakota, 58104, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

US (2)