Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00005905

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005905
  •   2015/01/22
  •   2014/01/07
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02039128  (ClinicalTrials.gov)
  •   BTS743/13 // AKBM109H  (Aker Biomarine Antarctic AS)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Healthy
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Dietary Supplement: Krill oil or Fish oil
  •   Dietary Supplement: Placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Active control
  •   [---]*
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Change in relative amount of EPA and DHA in erythrocytes; time frame: Baseline to Week 12

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Number of participants with Adverse Events as a Measure of Safety and Tolerability; time frame: Baseline to Week 12
- Change in relative amount of EPA and DHA in erythrocytes; time frame: Baseline to Week 6
- Blood lipid status; time frame: Baseline to Week 12
- Quality of Life; time frame: Baseline to week 12
- Mood Scores by a Likert Scale; time frame: Baseline to week 12

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2014/01/31
  •   240
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   50   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Aker Biomarine Antarctic AS
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Aker Biomarine Antarctic AS
    • Trygve Bergeland, PhD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Christiane Schön, MSc 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.