Heart DiseaseNCT00536185
Heart & Health Study
A study testing Fish Oil in people with Heart Disease, run by USDA, Western Human Nutrition Research Center at 3 sites in United States.
Trial summary
We hope to learn more about why certain people have higher levels of the 5-LO protein and whether taking fish oil supplements gives such individuals greater protection than others against cardiovascular disease. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2006to Jul 2008
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- African-American, Black, or persons of African Descent
- Generally Healthy
- 20 - 59 years of age
Who cannot join
- Chronic Diseases (Heart disease, cancer, diabetes, etc.)
- Smoke > 14 cigarettes per week
- Consume > 14 alcoholic drinks per week
- Pregnant Women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UC Davis, Western Human Nutrition Research Center
Davis, California, 95616
Ethnich Health Institute
Oakland, California, 94609
UC Davis (TICON-1)
Sacramento, California, 95820
About this study
Official title: Variation in the ALOX5 Gene and Response to Omega-3 Fatty Acid Supplements
We hope to learn more about why certain people have higher levels of the 5-LO protein and whether taking fish oil supplements gives such individuals greater protection than others against cardiovascular disease. The 5-LO protein is important in the development of heart disease because it converts a type of oil from meat into a compound that can cause inflammation in blood vessels. This inflammation is a major cause of heart disease.
Researchers think that people with higher levels of a protein called 5-LO in their white blood cells may have a healthier response to using fish oil supplements than do people with lower levels of this protein.
Read the detailed description
Fish oil supplements will be given to subjects with different variants in the promoter region of the arachidonate 5-lipoxygenase (ALOX5) gene and outcome measures will be evaluated after 6 wk of supplementation. These outcomes include ALOX5 protein levels (also called 5-lipoxygenase, or 5-LO), leukotriene levels, markers of inflammation, and blood lipids. The 5-LO enzyme converts arachidonic acid (AA) to leukotrienes that promote inflammation. Subjects with different promoter variants are hypothesized to have different basal or stimulated levels of 5-LO expression. Preliminary data suggests that subjects with a promoter variant that causes increased 5-LO expression also may have a "better" anti-inflammatory or lipid-lowering response to fish oil supplements. The homozygous variant genotype is much more common in African Americans than other groups thus we propose to conduct the study in African Americans. The fish oil eicosapentaenoic acid (EPA) competitively inhibits conversion of AA to pro-inflammatory 4-series leukotrienes.
The grant proposes to conduct a community-based, double-masked, randomized, placebo-controlled trial; n = 15/group, total = 166 (genotypes 44 will have n = 8). The intervention group will receive 5.0 g/d fish oil concentrate (3.0 g/d EPA + DHA) for 6 wk. The study will be conducted in Oakland, Davis, and Sacramento, California where African Americans 20 - 59 y of age without serious chronic disease will be recruited.
A recent observational study indicates that subjects with a variant allele for ALOX5 may be at greater risk for cardiovascular disease and, at the same time, may derive a greater benefit from omega-3 fatty acid supplements than do subjects homozygous for the common allele. The variant alleles are less common in the white population (18%) than in the black population (52%). Since African Americans have a higher prevalence of cardiovascular disease and of the ALOX5 variant alleles, as shown in epidemiologic studies, they may have a greater benefit from omega-3 supplementation in the reduction of inflammation and cardiovascular risk factors. Recruitment will be conducted through the community service, Ethnic Health Institute (EHI), of Alta Bates Summit Medical Center in conjunction with UCD, and outreach efforts from the USDA, ARS, Western Human Nutrition Research Center (WHNRC) at UC Davis. We will determine if subjects with one or two variant ALOX5 alleles have higher ALOX5 gene expression, higher production of AA-derived leukotrienes, and a better response to omega-3 supplements than do subjects homozygous for the common allele.
- Conditions
- Heart Disease
- Being tested
- Fish Oil, Placebo
- Keywords
- ALOX5, 5-lipoxygenase, Heart Disease, Blacks
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
capsules, 5.0 g/d fish oil concentrate (3.0 g/d EPA + DHA), 6 weeks
PlaceboDietary supplement
capsule, 5.0 g/d corn/soybean oil (50/50 mixture), 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Fish Oil |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(a) ALOX5 mRNA and protein in resting and stimulated cultures of purified monocytes and purified granulocytes (b) Arachidonic acid-derived leukotrienes in resting and stimulated cultures of whole blood, purified monocytes and purified granulocytes
Measured: 6 weeks
Secondary outcomes (1)
Proinflammatory cytokines, C-reactive protein, triglycerides, glucose and insulin in plasma, and resting heart rate and blood pressure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startDec 2006
- Primary completionJul 2008
- Study completionJul 2008
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 Heart DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS), University of California, Davis, USDA Beltsville Human Nutrition Research Center, Alta Bates Summit Medical Center, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Charles B Stephensen, PhD, Principal investigator, UC Davis & U.S. Department of Agriculture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536185
- Sponsor's protocol ID
- R21AT003411-01A1
- Other IDs
- R21AT003411-01A1
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2007
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Vikman S, Brena RM, Armstrong P, Hartiala J, Stephensen CB, Allayee H. Functional analysis of 5-lipoxygenase promoter repeat variants. Hum Mol Genet. 2009 Dec 1;18(23):4521-9. doi: 10.1093/hmg/ddp414. Epub 2009 Aug 28.
PubMed 19717473O'Sullivan A, Armstrong P, Schuster GU, Pedersen TL, Allayee H, Stephensen CB, Newman JW. Habitual diets rich in dark-green vegetables are associated with an increased response to omega-3 fatty acid supplementation in Americans of African ancestry. J Nutr. 2014 Feb;144(2):123-31. doi: 10.3945/jn.113.181875. Epub 2013 Nov 20.
PubMed 24259553Armstrong P, Kelley DS, Newman JW, Staggers FE Sr, Hartiala J, Allayee H, Stephensen CB. Arachidonate 5-lipoxygenase gene variants affect response to fish oil supplementation by healthy African Americans. J Nutr. 2012 Aug;142(8):1417-28. doi: 10.3945/jn.112.159814. Epub 2012 Jun 27.
PubMed 22739369Stephensen CB, Armstrong P, Newman JW, Pedersen TL, Legault J, Schuster GU, Kelley D, Vikman S, Hartiala J, Nassir R, Seldin MF, Allayee H. ALOX5 gene variants affect eicosanoid production and response to fish oil supplementation. J Lipid Res. 2011 May;52(5):991-1003. doi: 10.1194/jlr.P012864. Epub 2011 Feb 4.
PubMed 21296957Hartiala J, Li D, Conti DV, Vikman S, Patel Y, Tang WH, Brennan ML, Newman JW, Stephensen CB, Armstrong P, Hazen SL, Allayee H. Genetic contribution of the leukotriene pathway to coronary artery disease. Hum Genet. 2011 Jun;129(6):617-27. doi: 10.1007/s00439-011-0963-3. Epub 2011 Feb 4.
PubMed 21293878Snodgrass RG, Stephensen CB, Armstrong P, Allayee H, Snodgrass IF, Laugero KD, Newman JW. Cytokine and Oxylipin Production in Resting and LPS-Stimulated Monocytes From Americans of African Ancestry Are Influenced by ALOX5 Promoter Tandem Repeat Polymorphisms. Mediators Inflamm. 2026;2026(1):e8899139. doi: 10.1155/mi/8899139.
PubMed 42141771
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in the ALOX5 Gene and Response to Omega-3 Fatty Acid Supplements
- ClinicalTrials.gov ID
- NCT00536185
- Acronym / sponsor ID
- R21AT003411-01A1
- Conditions
- Heart Disease
- Keywords
- ALOX5, 5-lipoxygenase, Heart Disease, Blacks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS), University of California, Davis, USDA Beltsville Human Nutrition Research Center, Alta Bates Summit Medical Center, University of Southern California
- Study start
- Dec 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Sep 2007 (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.
We hope to learn more about why certain people have higher levels of the 5-LO protein and whether taking fish oil supplements gives such individuals greater protection than others against cardiovascular disease. The 5-LO protein is important in the development of heart disease because it converts a type of oil from meat into a compound that can cause inflammation in blood vessels. This inflammation is a major cause of heart disease.
Researchers think that people with higher levels of a protein called 5-LO in their white blood cells may have a healthier response to using fish oil supplements than do people with lower levels of this protein.
Detailed description
Fish oil supplements will be given to subjects with different variants in the promoter region of the arachidonate 5-lipoxygenase (ALOX5) gene and outcome measures will be evaluated after 6 wk of supplementation. These outcomes include ALOX5 protein levels (also called 5-lipoxygenase, or 5-LO), leukotriene levels, markers of inflammation, and blood lipids. The 5-LO enzyme converts arachidonic acid (AA) to leukotrienes that promote inflammation. Subjects with different promoter variants are hypothesized to have different basal or stimulated levels of 5-LO expression. Preliminary data suggests that subjects with a promoter variant that causes increased 5-LO expression also may have a "better" anti-inflammatory or lipid-lowering response to fish oil supplements. The homozygous variant genotype is much more common in African Americans than other groups thus we propose to conduct the study in African Americans. The fish oil eicosapentaenoic acid (EPA) competitively inhibits conversion of AA to pro-inflammatory 4-series leukotrienes.
The grant proposes to conduct a community-based, double-masked, randomized, placebo-controlled trial; n = 15/group, total = 166 (genotypes 44 will have n = 8). The intervention group will receive 5.0 g/d fish oil concentrate (3.0 g/d EPA + DHA) for 6 wk. The study will be conducted in Oakland, Davis, and Sacramento, California where African Americans 20 - 59 y of age without serious chronic disease will be recruited.
A recent observational study indicates that subjects with a variant allele for ALOX5 may be at greater risk for cardiovascular disease and, at the same time, may derive a greater benefit from omega-3 fatty acid supplements than do subjects homozygous for the common allele. The variant alleles are less common in the white population (18%) than in the black population (52%). Since African Americans have a higher prevalence of cardiovascular disease and of the ALOX5 variant alleles, as shown in epidemiologic studies, they may have a greater benefit from omega-3 supplementation in the reduction of inflammation and cardiovascular risk factors. Recruitment will be conducted through the community service, Ethnic Health Institute (EHI), of Alta Bates Summit Medical Center in conjunction with UCD, and outreach efforts from the USDA, ARS, Western Human Nutrition Research Center (WHNRC) at UC Davis. We will determine if subjects with one or two variant ALOX5 alleles have higher ALOX5 gene expression, higher production of AA-derived leukotrienes, and a better response to omega-3 supplements than do subjects homozygous for the common allele.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Fish Oil |
| 2 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- African-American, Black, or persons of African Descent
- Generally Healthy
- 20 - 59 years of age
Key exclusion criteria (4 listed)
- Chronic Diseases (Heart disease, cancer, diabetes, etc.)
- Smoke > 14 cigarettes per week
- Consume > 14 alcoholic drinks per week
- Pregnant Women
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 Oilcapsules, 5.0 g/d fish oil concentrate (3.0 g/d EPA + DHA), 6 weeks | Dietary supplement | 1 |
| Placebocapsule, 5.0 g/d corn/soybean oil (50/50 mixture), 6 weeks | Dietary supplement | 2 |
Primary outcome
(a) ALOX5 mRNA and protein in resting and stimulated cultures of purified monocytes and purified granulocytes (b) Arachidonic acid-derived leukotrienes in resting and stimulated cultures of whole blood, purified monocytes and purified granulocytes
Time frame: 6 weeks
1 secondary outcome
Proinflammatory cytokines, C-reactive protein, triglycerides, glucose and insulin in plasma, and resting heart rate and blood pressure
Time frame: 6 weeks
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 25 Mar 2026.
- Results publication: PubMed 19717473Vikman S, Brena RM, Armstrong P, Hartiala J, Stephensen CB, Allayee H. Functional analysis of 5-lipoxygenase promoter repeat variants. Hum Mol Genet. 2009 Dec 1;18(23):4521-9. doi: 10.1093/hmg/ddp414. Epub 2009 Aug 28.
- Results publication: PubMed 24259553O'Sullivan A, Armstrong P, Schuster GU, Pedersen TL, Allayee H, Stephensen CB, Newman JW. Habitual diets rich in dark-green vegetables are associated with an increased response to omega-3 fatty acid supplementation in Americans of African ancestry. J Nutr. 2014 Feb;144(2):123-31. doi: 10.3945/jn.113.181875. Epub 2013 Nov 20.
- Results publication: PubMed 22739369Armstrong P, Kelley DS, Newman JW, Staggers FE Sr, Hartiala J, Allayee H, Stephensen CB. Arachidonate 5-lipoxygenase gene variants affect response to fish oil supplementation by healthy African Americans. J Nutr. 2012 Aug;142(8):1417-28. doi: 10.3945/jn.112.159814. Epub 2012 Jun 27.
- Results publication: PubMed 21296957Stephensen CB, Armstrong P, Newman JW, Pedersen TL, Legault J, Schuster GU, Kelley D, Vikman S, Hartiala J, Nassir R, Seldin MF, Allayee H. ALOX5 gene variants affect eicosanoid production and response to fish oil supplementation. J Lipid Res. 2011 May;52(5):991-1003. doi: 10.1194/jlr.P012864. Epub 2011 Feb 4.
- Results publication: PubMed 21293878Hartiala J, Li D, Conti DV, Vikman S, Patel Y, Tang WH, Brennan ML, Newman JW, Stephensen CB, Armstrong P, Hazen SL, Allayee H. Genetic contribution of the leukotriene pathway to coronary artery disease. Hum Genet. 2011 Jun;129(6):617-27. doi: 10.1007/s00439-011-0963-3. Epub 2011 Feb 4.
- Derived from this study: PubMed 42141771Snodgrass RG, Stephensen CB, Armstrong P, Allayee H, Snodgrass IF, Laugero KD, Newman JW. Cytokine and Oxylipin Production in Resting and LPS-Stimulated Monocytes From Americans of African Ancestry Are Influenced by ALOX5 Promoter Tandem Repeat Polymorphisms. Mediators Inflamm. 2026;2026(1):e8899139. doi: 10.1155/mi/8899139.
- Western Human Nutrition Research websiteLink 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.
Charles B Stephensen, PhD principal investigator
UC Davis & U.S. Department of Agriculture
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil in people with Heart Disease, run by USDA, Western Human Nutrition Research Center at 3 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 3 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
(a) ALOX5 mRNA and protein in resting and stimulated cultures of purified monocytes and purified granulocytes (b) Arachidonic acid-derived leukotrienes in resting and stimulated cultures of whole blood, purified monocytes and purified granulocytes (time frame: 6 weeks). 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 NCT00536185, 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 25 Mar 2026.