KOmparison Study KOmparison Study

Aker Biomarine

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Krill oil or Fish oil

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02039128

BTS743/13 // AKBM109H

Details and patient eligibility

About

In this double blind, placebo controlled, parallel group study, the relative uptake of 1g/d krill oil in comparison to 1g/d fish oil in healthy female and male adults will be assessed.

Primary objective is to determine if a 12 week supplementation with krill oil increases tissue levels in erythrocytes (omega-3 index) significantly more than fish oil after dose adjustments to EPA and DHA levels.

Enrollment

240 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Provide written informed consent
Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator
Be in general good health with no existing co-morbidities
Be aged between 20 and 50 years
Both genders allowed (at least 40% of each gender to be recruited into the study)
Have a body mass index (BMI) between 19 and 30 kg/m² (extremes included)
Have a omega-3 index in erythrocytes of <6.2% at screening
Have clinically normal findings for haematology and clinical chemistry (or clinically insignificant, if value is outside of the normal range)
Be willing to maintain dietary habits and physical activity levels throughout the trial period (next 12 weeks)
Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less (a list of fish and seafood considered to be fatty is provided to volunteers)
Be willing to avoid all fish and seafood meals in the 3 days before each scheduled clinic visit
Be willing to avoid alcohol in the 24 hours before each scheduled clinic visit
Be willing to avoid sportive activity in the 24 hours before each scheduled clinic visit
Be willing to complete questionnaires, records and diaries associated with the study

Exclusion criteria

Smoking
Diseases or disorders that include: Rheumatoid arthritis, chronic serious illness, cardiovascular problems, liver and kidney disease, diabetes, endocrine or metabolic disease, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological or psychological disease, bleeding disorders, experiences platelet abnormalities, gastrointestinal disorders that could interfere with fat absorption, acute and history of cancer, HIV, hepatitis B or C, an intention to lose weight
Pregnant or nursing women or women of child-bearing potential whose urinary pregnancy test at screening is positive
Postmenopausal women
Known allergy to crustaceans (shellfish) or fish
Known alcohol or drug abuse within the previous year of screening
More than 20 alcohol Units per week
Clinically significant illness within 3 days prior to dosing (fever; inability to work etc.)
Donation of blood or similar blood loss within the previous 30 days before screening
Participation in a clinical trial with an investigational product within 90 days before screening
Present or recent use (within 3 months of screening) of any medication which is a known lipid modifying agent
Present or recent use (within 3 months of screening) of dietary supplements that affect the level of blood cholesterol and triglycerides, such as fish oil supplements, niacin, etc
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 (within 3 months of screening) of any long-chain omega-3 or omega-6 fatty acid supplement