- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02039128
KOmparison Study KOmparison Study
A Double-blind, Randomized, Placebo-controlled Study to Assess Changes in the Omega-3 Index in Erythrocytes After Twelve Weeks of Daily Intake of SuperbaTM Krill Oil or Fish Oil
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Esslingen, Germany, 73728
- BioTeSys GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Krill oil
1 gram per day in 12 weeks
|
|
ACTIVE_COMPARATOR: Fish oil
1 gram per day in 12 weeks
|
|
PLACEBO_COMPARATOR: Placebo
1 gram per day in 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in relative amount of EPA and DHA in erythrocytes
Time Frame: Baseline to Week 12
|
Baseline to Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Baseline to Week 12
|
Baseline to Week 12
|
Change in relative amount of EPA and DHA in erythrocytes
Time Frame: Baseline to Week 6
|
Baseline to Week 6
|
Blood lipid status
Time Frame: Baseline to Week 12
|
Baseline to Week 12
|
Quality of Life
Time Frame: Baseline to week 12
|
Baseline to week 12
|
Mood Scores by a Likert Scale
Time Frame: Baseline to week 12
|
Baseline to week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Trygve Bergeland, PhD, Aker Biomarine Antarctic AS
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BTS743/13 // AKBM109H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States