InflammationNCT02670356
Study Comparing Fish Oil and Krill Oil
A study testing Fish oil and Krill oil in people with Inflammation and Dyslipidemia, run by Tufts University at 1 site in United States.
Trial summary
Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Dyslipidemia
- What is being tested?
- Fish oil and Krill oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jul 2016
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fasting plasma triglyceride levels between 150 and 500 mg/dL
- C-reactive protein (CRP) levels ≥2 µg/mL
- at least one of the following criteria for the definition of metabolic syndrome: abdominal obesity (waist circumference >40 inches in men and >35 inches in women), hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and fasting glucose ≥110 mg/dL.
Who cannot join
- high-fish diets (>2 fish meals/week)
- taking fish oil supplements or supplements containing EPA or DHA
- regular use of anti-inflammatory medications
- Above normal coagulation time or use of anticoagulant medications
- allergy to fish, fish oil, or shellfish
- uncontrolled thyroid dysfunction
Show all 11Show fewer
- insulin-dependent type 2 diabetes mellitus
- kidney or liver disease
- smoking
- drinking more than 7 alcoholic drinks/week
- use of lipid-lowering medications or medications known to alter lipoprotein metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300 mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.
Read the detailed description
Inflammation plays a pivotal role in the pathogenesis of several chronic diseases including cardiovascular disease and diabetes mellitus. There has been some evidence that fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), reduces the risk or severity of these diseases, leading several government and health organizations to advocate an increased consumption of fish or fish oil. Fish oil contains EPA and DHA either as triglycerides or as ethyl esters. Recently, krill oil has gained popularity as an EPA and DHA supplement. Krill oil contains EPA and DHA in phospholipid, triglyceride, and free fatty acid form.
Some studies have shown that the bioavailability of EPA and DHA in krill oil is higher than in fish oil and that smaller doses of krill oil are therefore sufficient to observe a significant effect on the desired outcome (inflammation, plasma lipid levels).
The central hypothesis of this proposal is that the dose of the EPA and DHA omega-3 fatty acids is more important than their bioavailability in effecting changes in systemic inflammation and lipid metabolism.
- Conditions
- Inflammation, Dyslipidemia
- Being tested
- Fish oil, Krill oil
- Keywords
- fish oil, EPA, DHA, krill oil, Metabolic Syndrome
- Medical subject headings
- Inflammation, Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDietary supplement
two 750 mg/capsules/day
Krill oilDietary supplement
one 300 mg capsule/day
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | fish oil, 1500 mg/day, EPA:DHA ratio of 4:1, each capsule containing 750 mg total EPA+DHA, 2 capsules/day for 10 weeks Receives: Dietary Supplement: Fish oil |
| krill oil | Experimental | krill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks Receives: Dietary Supplement: Krill oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega-3 index
red blood cell membrane levels of EPA and DHA, as percent of total fatty acids
Measured: 10 weeks
Secondary outcomes (7)
interleukin-6 (IL-6)
plasma levels as pg/mL
Measured: 10 weeks
Tumor necrosis factor alpha (TNF-alpha)
plasma levels as pg/mL
Measured: 10 weeks
Monocyte chemoattractant protein 1 (MCP-1)
plasma levels as pg/mL
Measured: 10 weeks
Total cholesterol
plasma levels as mg/dL
Measured: 10 weeks
LDL cholesterol
plasma levels as mg/dL
Measured: 10 weeks
HDL cholesterol
plasma levels as mg/dL
Measured: 10 weeks
TG
plasma levels as mg/dL
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Study stopped by the company funding the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Prevention Pharmaceuticals
- Responsible party
- Principal investigator, Stefania lamon-Fava, Tufts University
- Investigators
- Stefania Lamon-Fava, Ph.D., Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670356
- Sponsor's protocol ID
- 11787
- Status last verified
- Apr 2017
- First submitted
- 23 Dec 2015
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Fish Oil and Krill Oil
- ClinicalTrials.gov ID
- NCT02670356
- Acronym / sponsor ID
- 11787
- Conditions
- Inflammation, Dyslipidemia
- Keywords
- fish oil, EPA, DHA, krill oil, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped by the company funding the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Prevention Pharmaceuticals
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Feb 2016 (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.
Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300 mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.
Detailed description
Inflammation plays a pivotal role in the pathogenesis of several chronic diseases including cardiovascular disease and diabetes mellitus. There has been some evidence that fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), reduces the risk or severity of these diseases, leading several government and health organizations to advocate an increased consumption of fish or fish oil. Fish oil contains EPA and DHA either as triglycerides or as ethyl esters. Recently, krill oil has gained popularity as an EPA and DHA supplement. Krill oil contains EPA and DHA in phospholipid, triglyceride, and free fatty acid form.
Some studies have shown that the bioavailability of EPA and DHA in krill oil is higher than in fish oil and that smaller doses of krill oil are therefore sufficient to observe a significant effect on the desired outcome (inflammation, plasma lipid levels).
The central hypothesis of this proposal is that the dose of the EPA and DHA omega-3 fatty acids is more important than their bioavailability in effecting changes in systemic inflammation and lipid metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Dietary Supplement: Fish oilfish oil, 1500 mg/day, EPA:DHA ratio of 4:1, each capsule containing 750 mg total EPA+DHA, 2 capsules/day for 10 weeks |
| krill oil | Experimental | Dietary Supplement: Krill oilkrill oil, 300 mg/day, each capsule containing 74 mg total EPA+DHA , 1 capsule/day for 10 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fasting plasma triglyceride levels between 150 and 500 mg/dL
- C-reactive protein (CRP) levels ≥2 µg/mL
- at least one of the following criteria for the definition of metabolic syndrome: abdominal obesity (waist circumference >40 inches in men and >35 inches in women), hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and fasting glucose ≥110 mg/dL.
Key exclusion criteria (11 listed)
- high-fish diets (>2 fish meals/week)
- taking fish oil supplements or supplements containing EPA or DHA
- regular use of anti-inflammatory medications
- Above normal coagulation time or use of anticoagulant medications
- allergy to fish, fish oil, or shellfish
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 |
|---|---|---|
| Fish oiltwo 750 mg/capsules/day | Dietary supplement | Fish oil |
| Krill oilone 300 mg capsule/day | Dietary supplement | krill oil |
Primary outcome
Omega-3 index
Time frame: 10 weeks
red blood cell membrane levels of EPA and DHA, as percent of total fatty acids
7 secondary outcomes
interleukin-6 (IL-6)
Time frame: 10 weeks
Tumor necrosis factor alpha (TNF-alpha)
Time frame: 10 weeks
Monocyte chemoattractant protein 1 (MCP-1)
Time frame: 10 weeks
Total cholesterol
Time frame: 10 weeks
LDL cholesterol
Time frame: 10 weeks
HDL cholesterol
Time frame: 10 weeks
TG
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: Study stopped by the company funding the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Stefania Lamon-Fava, Ph.D. principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil and Krill oil in people with Inflammation and Dyslipidemia, run by Tufts University at 1 site 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 26 Apr 2017. 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 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 was stopped early (reason given: Study stopped by the company funding the study). Results are not available in the source record.
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?
Omega-3 index (time frame: 10 weeks). 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 26 Apr 2017.