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Elevated cholesterol, including triglyceride levels, can lead to the development of cardiovascular disease in adulthood. A diet that is rich in omega-3 fatty acids (O3FA) can improve triglyceride levels in a way that is safe and does not require medication.
This is a single-center, prospective, unblinded, randomized-controlled dietary intervention study to assess the impact of an omega-3 fatty acid diet compared to a standard lifestyle intervention on serum triglyceride in patients with hypertriglyceridemia. The study consists of an 8-week dietary treatment period followed by an 8-week observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard lifestyle intervention + omega-3 fatty acid enriched diet | Experimental | American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) + omega-3 fatty acid enriched foods |
|
| Standard lifestyle intervention | Active Comparator | American Heart Association Target Diet/Standard Lifestyle Intervention (SLI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet intervention | Other | The intervention group will receive diet counseling and information to implement a standard lifestyle intervention plus omega-3 fatty acid enriched foods Diet assessment and counseling provided throughout study. |
| Measure | Description | Time Frame |
|---|---|---|
| change in serum triglyceride level after an 8-week diet intervention compared to baseline | The study will test whether omega-3 fatty acid enriched diet is associated with a 20% or greater reduction in serum triglyceride levels. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline | Total levels of omega-3 fatty acids in red blood cell membrane phospholipids are measured. Percentages are reported as an index. The study will identify the index/total omega-3 fatty acid in red blood cells following initiation of an omega-3 fatty acid enriched diet. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carissa Baker-Smith, MD, MPH, MS | Nemours Cardiac Center, Nemours Children's Hospital Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Cardiac Center, Nemours Children's Hospital Delaware | Wilmington | Delaware | 19803 | United States |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group | Other | The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study. |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D008722 | Methods |