CClinicalTrials.gg
CompletedNCT02039128Updated Jul 29, 2014

KOmparison Study KOmparison Study

An interventional study of Krill oil or Fish oil and Placebo in Healthy, sponsored by Aker BioMarine Human Ingredients AS. Completed at 1 site in Germany. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-29.

Sponsored by Aker BioMarine Human Ingredients AS · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Aker BioMarine Human Ingredients AS is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Krill oil

    1 gram per day in 12 weeks

    Dietary Supplement: Krill oil or Fish oil

  • Active comparator
    Fish oil

    1 gram per day in 12 weeks

    Dietary Supplement: Krill oil or Fish oil

  • Placebo comparator
    Placebo

    1 gram per day in 12 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementKrill oil or Fish oil
  • Dietary supplementPlacebo
06

What researchers measure

Primary outcomes

  1. Change in relative amount of EPA and DHA in erythrocytes

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Number of participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: Baseline to Week 12

  2. Change in relative amount of EPA and DHA in erythrocytes

    Time frame: Baseline to Week 6

  3. Blood lipid status

    Time frame: Baseline to Week 12

  4. Quality of Life

    Time frame: Baseline to week 12

  5. Mood Scores by a Likert Scale

    Time frame: Baseline to week 12

07

Study locations

1 site
  • BioTeSys GmbH
    Esslingen, 73728, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02039128
Lead sponsor
Aker BioMarine Human Ingredients AS
Responsible party
Sponsor
First posted
Jan 17, 2014
Start date
Jan 2014
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jul 29, 2014

Study contacts

Trygve Bergeland, PhD
study director · Aker BioMarine Human Ingredients AS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion