Healthy VolunteersKrillNCT01323036
Krill Oil Study Compared to Fish Oil
A study testing Krill oil and Fish Oil in people with Healthy Volunteers, run by University of Manitoba at 1 site in Canada.
Trial summary
The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Krill oil and Fish Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Nov 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and premenopausal not pregnant or nursing women between 18 and 49 years old.
Who cannot join
- smokers
- rheumatoid arthritis
- chronic illness
- cardiovascular problems
- dyslipidemia
- liver and kidney disease
Show all 29Show fewer
- diabetes
- endocrine or metabolic disease
- inflammatory bowel disease
- pancreatitis
- gallbladder or biliary disease
- neurological/psychological disease
- bleeding disorders
- experienced platelet abnormalities
- gastrointestinal disorders that could interfere with fat absorption
- hypertension
- history of cancer
- an intention to lose weight
- use of anticoagulant
- serum triglycerides (TG) >200 mg/dL, and/or total cholesterol (TC) >240 mg/dL, and/or LDL-cholesterol (LDL-C) >160 mg/dL
- hypertension or lipid lowering medications
- consumption of more than one alcoholic drinks/day
- Consumption of more than one fish or seafood serving
- one month prior to the start of the study
- omega-6 fatty acids in the past 6 months
- planned to consume seafood products or fish or to use any omega-3 or omega-6 fatty acids nutritional supplements at anytime in the duration of the study
- planned to to become pregnant during the study period
- BMI>28
- allergies to fish seafood or corn
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers
The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo.
Read the detailed description
The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. An additional purpose is to evaluate the lipid-lowering efficacy and safety of consumption of Krill Oil and Fish Oil to a placebo product. It has been shown that the ingestion of Krill Oil leads to better absorption of omega-3 fatty acids compared to ingestion of Fish Oil. It was also shown that consumption of krill oil and fish oil result in a favorable modification of lipid profiles. Therefore, it is anticipated that consumption of these krill oil and fish oil will improve lipid profile, as well as other health-related markers and will be safe and well tolerated.
- Conditions
- Healthy Volunteers
- Being tested
- Krill oil, Fish Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Krill oilDietary supplement
Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg
Fish OilDietary supplement
Fish oil: Total omega-3 fatty acids: 560-660 mg
| Study group | Role | What they receive |
|---|---|---|
| Krill Oil | Experimental | Not described Receives: Dietary Supplement: Krill oil |
| Fish Oil | Experimental | Not described Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Enzymotec
- Responsible party
- Principal investigator, Dr. Peter Jones, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323036
- Sponsor's protocol ID
- B2011:014
- Acronym
- Krill
- Status last verified
- Nov 2012
- First submitted
- 23 Mar 2011
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramprasath VR, Eyal I, Zchut S, Shafat I, Jones PJ. Supplementation of krill oil with high phospholipid content increases sum of EPA and DHA in erythrocytes compared with low phospholipid krill oil. Lipids Health Dis. 2015 Nov 4;14:142. doi: 10.1186/s12944-015-0142-y.
PubMed 26537218Ramprasath VR, Eyal I, Zchut S, Jones PJ. Enhanced increase of omega-3 index in healthy individuals with response to 4-week n-3 fatty acid supplementation from krill oil versus fish oil. Lipids Health Dis. 2013 Dec 5;12:178. doi: 10.1186/1476-511X-12-178.
PubMed 24304605
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01323036
- Acronym / sponsor ID
- Krill / B2011:014
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Enzymotec
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Mar 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 main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo.
Detailed description
The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. An additional purpose is to evaluate the lipid-lowering efficacy and safety of consumption of Krill Oil and Fish Oil to a placebo product. It has been shown that the ingestion of Krill Oil leads to better absorption of omega-3 fatty acids compared to ingestion of Fish Oil. It was also shown that consumption of krill oil and fish oil result in a favorable modification of lipid profiles. Therefore, it is anticipated that consumption of these krill oil and fish oil will improve lipid profile, as well as other health-related markers and will be safe and well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Krill Oil | Experimental | Dietary Supplement: Krill oil |
| Fish Oil | Experimental | Dietary Supplement: Fish Oil |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men and premenopausal not pregnant or nursing women between 18 and 49 years old.
Key exclusion criteria (29 listed)
- smokers
- rheumatoid arthritis
- chronic illness
- cardiovascular problems
- dyslipidemia
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 oilKrill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg | Dietary supplement | Krill Oil |
| Fish OilFish oil: Total omega-3 fatty acids: 560-660 mg | Dietary supplement | Fish Oil |
Primary outcome
Bioavailability
Time frame: 1 month
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 22 Nov 2012.
- Derived from this study: PubMed 26537218Ramprasath VR, Eyal I, Zchut S, Shafat I, Jones PJ. Supplementation of krill oil with high phospholipid content increases sum of EPA and DHA in erythrocytes compared with low phospholipid krill oil. Lipids Health Dis. 2015 Nov 4;14:142. doi: 10.1186/s12944-015-0142-y.
- Derived from this study: PubMed 24304605Ramprasath VR, Eyal I, Zchut S, Jones PJ. Enhanced increase of omega-3 index in healthy individuals with response to 4-week n-3 fatty acid supplementation from krill oil versus fish oil. Lipids Health Dis. 2013 Dec 5;12:178. doi: 10.1186/1476-511X-12-178.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Krill oil and Fish Oil in people with Healthy Volunteers, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 29 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 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Bioavailability (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01323036, which also lists 2 linked publications.
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 22 Nov 2012.