Healthy AdultsNCT01488747
Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride
A study testing Coromega Omega-3 Squeeze, Coromega Nectar and Barleans Swirl in people with Healthy Adults, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements versus an encapsulated triglyceride in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Coromega Omega-3 Squeeze, Coromega Nectar and Barleans Swirl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Apr 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults ages 18 to 60.
- Body mass index between 22 and 32 kg/m2.
- Medical history (interview) demonstrating good health.
- Nonsmoker.
- Consumption of a typical American diet with no unusual dietary habits.
- Willingness to comply with the study protocol.
- Low reported n-3 intake (<100 mg/d) on the Omega-3 Checklist
Who cannot join
- Any active, uncontrolled medical problem.
- Consumption of essential fatty acid supplements within the past 6 months.
- Use of lipid lowering drugs.
- Fish consumption greater than 1 fish meal per week
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride
The primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements versus an encapsulated triglyceride in defined plasma lipid pools.
The primary endpoints to be evaluated include the fatty acid composition of plasma lipids before and after consumption of a single dose of emulsified triglyceride based fish oil and triglyceride of similar n-3 compositions in capsule form. The investigators will measure changes in plasma phospholipid, and chylomicron fatty acids.
- Conditions
- Healthy Adults
- Being tested
- Coromega Omega-3 Squeeze, Coromega Nectar, Barleans Swirl, Nordic Omega-3 Softgel
- Keywords
- Omega-3 fatty acids, Phospholipid fatty acids, chymlomicron fatty acids, Bioavailability fo fish oil supplements in healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coromega Omega-3 SqueezeDietary supplement
660 mg EPA, 434 mg DHA
Coromega NectarDietary supplement
660 mg EPA, 436 mg DHA
Barleans SwirlDietary supplement
660 mg EPA, 660 mg DHA
Nordic Omega-3 SoftgelDietary supplement
660 mg EPA, 440 mg DHA
| Study group | Role | What they receive |
|---|---|---|
| Coromega Omega-3 Squeeze | Experimental | 5.03 g Receives: Dietary Supplement: Coromega Omega-3 Squeeze |
| Coromega Nectar | Experimental | 12.22 g Receives: Dietary Supplement: Coromega Nectar |
| Barleans Swirl | Experimental | 17.45 g Receives: Dietary Supplement: Barleans Swirl |
| Nordic Omega-3 Softgel | Active comparator | 4 softgels Receives: Dietary Supplement: Nordic Omega-3 Softgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for phospholipid fatty acids
Evaluation of the bioavailability of fatty acids from fish oil supplements
Measured: 48 hours
Secondary outcomes (1)
Area under the curve for chylomicron fatty acids
Evaluation of the bioavailability of fatty acids from fish oil supplements
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan Raatz, PhD, RD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488747
- Sponsor's protocol ID
- GFHNRC023
- Status last verified
- Aug 2018
- First submitted
- 6 Dec 2011
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Raatz SK, Redmon JB, Wimmergren N, Donadio JV, Bibus DM. Enhanced absorption of n-3 fatty acids from emulsified compared with encapsulated fish oil. J Am Diet Assoc. 2009 Jun;109(6):1076-81. doi: 10.1016/j.jada.2009.03.006.
PubMed 19465191
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Fish Oils: Emulsified vs. Capsular Triglyceride
- ClinicalTrials.gov ID
- NCT01488747
- Acronym / sponsor ID
- GFHNRC023
- Conditions
- Healthy Adults
- Keywords
- Omega-3 fatty acids, Phospholipid fatty acids, chymlomicron fatty acids, Bioavailability fo fish oil supplements in healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Dec 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 primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements versus an encapsulated triglyceride in defined plasma lipid pools.
The primary endpoints to be evaluated include the fatty acid composition of plasma lipids before and after consumption of a single dose of emulsified triglyceride based fish oil and triglyceride of similar n-3 compositions in capsule form. The investigators will measure changes in plasma phospholipid, and chylomicron fatty acids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coromega Omega-3 Squeeze | Experimental | Dietary Supplement: Coromega Omega-3 Squeeze5.03 g |
| Coromega Nectar | Experimental | Dietary Supplement: Coromega Nectar12.22 g |
| Barleans Swirl | Experimental | Dietary Supplement: Barleans Swirl17.45 g |
| Nordic Omega-3 Softgel | Active comparator | Dietary Supplement: Nordic Omega-3 Softgel4 softgels |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults ages 18 to 60.
- Body mass index between 22 and 32 kg/m2.
- Medical history (interview) demonstrating good health.
- Nonsmoker.
- Consumption of a typical American diet with no unusual dietary habits.
Key exclusion criteria (4 listed)
- Any active, uncontrolled medical problem.
- Consumption of essential fatty acid supplements within the past 6 months.
- Use of lipid lowering drugs.
- Fish consumption greater than 1 fish meal per week
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 |
|---|---|---|
| Coromega Omega-3 Squeeze660 mg EPA, 434 mg DHA | Dietary supplement | Coromega Omega-3 Squeeze |
| Coromega Nectar660 mg EPA, 436 mg DHA | Dietary supplement | Coromega Nectar |
| Barleans Swirl660 mg EPA, 660 mg DHA | Dietary supplement | Barleans Swirl |
| Nordic Omega-3 Softgel660 mg EPA, 440 mg DHA | Dietary supplement | Nordic Omega-3 Softgel |
Primary outcome
Area under the curve for phospholipid fatty acids
Time frame: 48 hours
Evaluation of the bioavailability of fatty acids from fish oil supplements
1 secondary outcome
Area under the curve for chylomicron fatty acids
Time frame: 48 hours
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 3 Aug 2018.
- Background: PubMed 19465191Raatz SK, Redmon JB, Wimmergren N, Donadio JV, Bibus DM. Enhanced absorption of n-3 fatty acids from emulsified compared with encapsulated fish oil. J Am Diet Assoc. 2009 Jun;109(6):1076-81. doi: 10.1016/j.jada.2009.03.006.
- USDA Grand Forks Human Nutrition Research CenterLink provided by the sponsor.
- 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.
Susan Raatz, PhD, RD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coromega Omega-3 Squeeze, Coromega Nectar and Barleans Swirl in people with Healthy Adults, run by USDA Grand Forks Human Nutrition Research Center 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 7 inclusion and 4 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 3 Aug 2018. 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 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?
Area under the curve for phospholipid fatty acids (time frame: 48 hours). 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 NCT01488747, which also lists 1 linked publication.
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 3 Aug 2018.