Omega-3 Fatty AcidsNCT01183520
Effect of High Omega-3 Fish Intake on Lipid Peroxidation
A study testing Omega-3 fish oil provided by salmon in people with Omega-3 Fatty Acids and Lipid Peroxidation, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The overall goal of this project is to identify an appropriate level of high omega-3 fish (salmon) consumption that will promote optimal omega 3 nutritional status without increasing the level of lipid oxidation in the body. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Omega-3 Fatty Acids, Lipid Peroxidation
- What is being tested?
- Omega-3 fish oil provided by salmon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-34.9
- Non-smoker
- Free of major medical conditions
- Willing to comply with protocol requirements
Who cannot join
- Use of lipid modifying drugs or supplements
- Taking fish oil or flax supplements
- Regular fish consumer
- Planning to gain to lose weight
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA ARS Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202
About this study
The overall goal of this project is to identify an appropriate level of high omega-3 fish (salmon) consumption that will promote optimal omega 3 nutritional status without increasing the level of lipid oxidation in the body.
Read the detailed description
Studies have demonstrated that the intakes of fatty fish and fish oils are associated with decreases in cardiovascular disease and other chronic disease states. This is related to the long chain omega-3 fatty acid (n-3) content of fish and fish oil, specifically eicosapentaenoic acid and docosahexaenoic acid. Although the consumption of high n-3 fish is recommended in the 2005 US Dietary Guidelines for Americans, no specific consumption levels are made for the fatty acid eicosapentaenoic acid (EPA) and/or the fatty acid docosahexaenoic acid (DHA) or total fish intake.
Consumption of high n-3 fish or dietary supplementation of fish oil will lead to increased levels of these fatty acids in plasma lipoproteins, cell and tissue lipid. This change in membrane lipid is thought to be responsible for the anti-inflammatory effects of n-3. Because highly unsaturated fatty acid are subject to peroxidation, the level of fish intake that is sufficient to modify membrane n-3 content and the exact level that enhances peroxidation is unknown.
We will perform a dose-response feeling study in which varied levels of fish (salmon) will be provided in random order separated by 4 or more week washout periods. We will assess the level of cell membrane enrichment with n-3 and the effect on lipid peroxidation outcomes.
- Conditions
- Omega-3 Fatty Acids, Lipid Peroxidation
- Being tested
- Omega-3 fish oil provided by salmon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fish oil provided by salmonDietary supplement
Eating 3 different amounts of provided salmon twice a week for four weeks
| Study group | Role | What they receive |
|---|---|---|
| 90 grams of Salmon | Active comparator | Subjects will consume 90 grams of salmon twice a week for 4 weeks Receives: Dietary Supplement: Omega-3 fish oil provided by salmon |
| 180 grams of salmon | Active comparator | Subjects will consume 180 grams of salmon twice a week for 4 weeks Receives: Dietary Supplement: Omega-3 fish oil provided by salmon |
| 270 Grams of Salmon | Active comparator | Subjects will consume 270 grams of salmon twice a week for 4 weeks Receives: Dietary Supplement: Omega-3 fish oil provided by salmon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long chain omega-3 fatty acid (n-3)
Effect of different levels of n-3 intake on n-3 fatty acids in plasma lipoproteins, cell and tissue lipids (cell enrichment)
Measured: 6 months
Secondary outcomes (1)
lipid peroxidation
Effect of different levels of n-3 intake on lipid peroxidation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Omega-3 Fatty AcidsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Agriculture (USDA), University of North Dakota
- Responsible party
- Sponsor
- Investigators
- Matthew Picklo, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183520
- Sponsor's protocol ID
- GFHNRC017
- Status last verified
- Jan 2022
- First submitted
- 16 Aug 2010
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Holman RT. Control of polyunsaturated acids in tissue lipids. J Am Coll Nutr. 1986;5(2):183-211. doi: 10.1080/07315724.1986.10720125.
PubMed 2873160Raatz SK, Bibus D, Thomas W, Kris-Etherton P. Total fat intake modifies plasma fatty acid composition in humans. J Nutr. 2001 Feb;131(2):231-4. doi: 10.1093/jn/131.2.231.
PubMed 11160538Roberts LJ 2nd, Montine TJ, Markesbery WR, Tapper AR, Hardy P, Chemtob S, Dettbarn WD, Morrow JD. Formation of isoprostane-like compounds (neuroprostanes) in vivo from docosahexaenoic acid. J Biol Chem. 1998 May 29;273(22):13605-12. doi: 10.1074/jbc.273.22.13605.
PubMed 9593698Song WL, Paschos G, Fries S, Reilly MP, Yu Y, Rokach J, Chang CT, Patel P, Lawson JA, Fitzgerald GA. Novel eicosapentaenoic acid-derived F3-isoprostanes as biomarkers of lipid peroxidation. J Biol Chem. 2009 Aug 28;284(35):23636-43. doi: 10.1074/jbc.M109.024075. Epub 2009 Jun 11.
PubMed 19520854Roberts LJ 2nd, Fessel JP. The biochemistry of the isoprostane, neuroprostane, and isofuran pathways of lipid peroxidation. Chem Phys Lipids. 2004 Mar;128(1-2):173-86. doi: 10.1016/j.chemphyslip.2003.09.016.
PubMed 15037162Raatz SK, Scheett AJ, Johnson LK, Jahns L. Validity of electronic diet recording nutrient estimates compared to dietitian analysis of diet records: randomized controlled trial. J Med Internet Res. 2015 Jan 20;17(1):e21. doi: 10.2196/jmir.3744.
PubMed 25604640
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Omega-3 Fish Intake on Lipid Peroxidation
- ClinicalTrials.gov ID
- NCT01183520
- Acronym / sponsor ID
- GFHNRC017
- Conditions
- Omega-3 Fatty Acids, Lipid Peroxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Collaborators
- United States Department of Agriculture (USDA), University of North Dakota
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Aug 2010 (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 overall goal of this project is to identify an appropriate level of high omega-3 fish (salmon) consumption that will promote optimal omega 3 nutritional status without increasing the level of lipid oxidation in the body.
Detailed description
Studies have demonstrated that the intakes of fatty fish and fish oils are associated with decreases in cardiovascular disease and other chronic disease states. This is related to the long chain omega-3 fatty acid (n-3) content of fish and fish oil, specifically eicosapentaenoic acid and docosahexaenoic acid. Although the consumption of high n-3 fish is recommended in the 2005 US Dietary Guidelines for Americans, no specific consumption levels are made for the fatty acid eicosapentaenoic acid (EPA) and/or the fatty acid docosahexaenoic acid (DHA) or total fish intake.
Consumption of high n-3 fish or dietary supplementation of fish oil will lead to increased levels of these fatty acids in plasma lipoproteins, cell and tissue lipid. This change in membrane lipid is thought to be responsible for the anti-inflammatory effects of n-3. Because highly unsaturated fatty acid are subject to peroxidation, the level of fish intake that is sufficient to modify membrane n-3 content and the exact level that enhances peroxidation is unknown.
We will perform a dose-response feeling study in which varied levels of fish (salmon) will be provided in random order separated by 4 or more week washout periods. We will assess the level of cell membrane enrichment with n-3 and the effect on lipid peroxidation outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 90 grams of Salmon | Active comparator | Dietary Supplement: Omega-3 fish oil provided by salmonSubjects will consume 90 grams of salmon twice a week for 4 weeks |
| 180 grams of salmon | Active comparator | Dietary Supplement: Omega-3 fish oil provided by salmonSubjects will consume 180 grams of salmon twice a week for 4 weeks |
| 270 Grams of Salmon | Active comparator | Dietary Supplement: Omega-3 fish oil provided by salmonSubjects will consume 270 grams of salmon twice a week for 4 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI 25-34.9
- Non-smoker
- Free of major medical conditions
- Willing to comply with protocol requirements
Key exclusion criteria (5 listed)
- Use of lipid modifying drugs or supplements
- Taking fish oil or flax supplements
- Regular fish consumer
- Planning to gain to lose weight
- Pregnant or lactating
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 |
|---|---|---|
| Omega-3 fish oil provided by salmonEating 3 different amounts of provided salmon twice a week for four weeks | Dietary supplement | 180 grams of salmon, 270 Grams of Salmon, 90 grams of Salmon |
Primary outcome
Long chain omega-3 fatty acid (n-3)
Time frame: 6 months
Effect of different levels of n-3 intake on n-3 fatty acids in plasma lipoproteins, cell and tissue lipids (cell enrichment)
1 secondary outcome
lipid peroxidation
Time frame: 6 months
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 2 Feb 2022.
- Background: PubMed 2873160Holman RT. Control of polyunsaturated acids in tissue lipids. J Am Coll Nutr. 1986;5(2):183-211. doi: 10.1080/07315724.1986.10720125.
- Background: PubMed 11160538Raatz SK, Bibus D, Thomas W, Kris-Etherton P. Total fat intake modifies plasma fatty acid composition in humans. J Nutr. 2001 Feb;131(2):231-4. doi: 10.1093/jn/131.2.231.
- Background: PubMed 9593698Roberts LJ 2nd, Montine TJ, Markesbery WR, Tapper AR, Hardy P, Chemtob S, Dettbarn WD, Morrow JD. Formation of isoprostane-like compounds (neuroprostanes) in vivo from docosahexaenoic acid. J Biol Chem. 1998 May 29;273(22):13605-12. doi: 10.1074/jbc.273.22.13605.
- Background: PubMed 19520854Song WL, Paschos G, Fries S, Reilly MP, Yu Y, Rokach J, Chang CT, Patel P, Lawson JA, Fitzgerald GA. Novel eicosapentaenoic acid-derived F3-isoprostanes as biomarkers of lipid peroxidation. J Biol Chem. 2009 Aug 28;284(35):23636-43. doi: 10.1074/jbc.M109.024075. Epub 2009 Jun 11.
- Background: PubMed 15037162Roberts LJ 2nd, Fessel JP. The biochemistry of the isoprostane, neuroprostane, and isofuran pathways of lipid peroxidation. Chem Phys Lipids. 2004 Mar;128(1-2):173-86. doi: 10.1016/j.chemphyslip.2003.09.016.
- Derived from this study: PubMed 25604640Raatz SK, Scheett AJ, Johnson LK, Jahns L. Validity of electronic diet recording nutrient estimates compared to dietitian analysis of diet records: randomized controlled trial. J Med Internet Res. 2015 Jan 20;17(1):e21. doi: 10.2196/jmir.3744.
- USDA Grand Forks Human Nutrition Research CenterLink provided by the sponsor.
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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.
Matthew Picklo, PhD 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 Omega-3 fish oil provided by salmon in people with Omega-3 Fatty Acids and Lipid Peroxidation, 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 4 inclusion and 5 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 2 Feb 2022. 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?
Long chain omega-3 fatty acid (n-3) (time frame: 6 months). 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 NCT01183520, which also lists 6 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 2 Feb 2022.