HealthyNCT01415388
Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides
A study testing Krill Oil in people with Healthy, run by Aker BioMarine Human Ingredients AS at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Krill Oil
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Diabetic subjects
- Staff of Cetero Research
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cetero Research
Fargo, North Dakota, 58104
Cetero Research
Saint Charles, Missouri, 63301
About this study
Official title: A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides
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
- Being tested
- Krill Oil
- Keywords
- Maintenance of normal blood triglyceride levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill OilDietary supplement
Also called Superba(TM) Krill Oil
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting serum triglycerides
Measured: Baseline (Day 1) and at Day 85
Secondary outcomes (1)
Omega-3 index
Measured: At Days 1, 42, and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aker BioMarine Human Ingredients AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415388
- Sponsor's protocol ID
- CHSI 1102-16
- Status last verified
- Feb 2013
- First submitted
- 10 Aug 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides
- ClinicalTrials.gov ID
- NCT01415388
- Acronym / sponsor ID
- CHSI 1102-16
- Conditions
- Healthy
- Keywords
- Maintenance of normal blood triglyceride levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aker BioMarine Human Ingredients ASIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krill OilAlso: Superba(TM) Krill Oil4 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 | Dietary supplement | – |
Primary outcome
Change in fasting serum triglycerides
Time frame: Baseline (Day 1) and at Day 85
1 secondary outcome
Omega-3 index
Time frame: At Days 1, 42, and 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill Oil in people with Healthy, run by Aker BioMarine Human Ingredients AS at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting serum triglycerides (time frame: Baseline (Day 1) and at Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.