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COVID-19 pandemic & expiration of grant funds
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The purpose of this study is to determine how eating fish raised to have different levels of omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated cardiovascular risk.
Consumption of fish high in long chain omega-3 fatty acids (LCn3) is associated with reduction of cardiovascular disease (CVD) risk. CVD is a major cause of death in the United States. The current obesity epidemic contributes significantly to elevated CVD risk by increasing inflammation and platelet dysfunction. Prevention of CVD is a public health goal and comprises several avenues of action, of which inclusion of LCn3-rich fish in the diet may be one of the most effective.
Obese participants will participate in a double blind, randomized, cross-over designed trial in which they will consume twice-weekly a prepared meal containing diploid (2N) farmed rainbow trout, triploid (3N) farmed rainbow trout containing higher levels of LCn3, or tilapia, a low LCn3 fish.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diploid Trout entrees | Experimental | Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal. |
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| Triploid Trout entrees | Experimental | Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal. |
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| Tilapia entrees | Experimental | Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2N Trout | Other | Diploid/2N trout source |
| |
| 3N Trout |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in platelet activation at week 6 of each treatment | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment | Baseline, Week 6 | |
| Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment | Baseline, Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Picklo, PhD | USDA Grand Forks Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA Grand Forks Human Nutrition Research Center | Grand Forks | North Dakota | 58203 | United States |
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| Label | URL |
|---|---|
| Grand Forks Human Nutrition Research Center Current Nutrition Studies | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2020 | Jan 18, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C097980 | melanin-concentrating hormone gene-related peptide, tilapia |
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| Other |
Triploid/3N trout source |
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| Tilapia | Other | Tilapia/control fish source |
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| Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment | Baseline, Week 6 |
| Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment | Baseline, Week 6 |
| Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment | Baseline, Week 6 |
| Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment | Baseline, Week 6 |
| Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment | Baseline, Week 6 |
| Change from baseline in platelet fatty acids at week 6 of each treatment | Baseline, Week 6 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |