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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003465-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.
The primary aim of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose Flaxseed Oil | Experimental | 2.2 g ALA (alpha-linolenic acid) per day |
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| High-dose Flaxseed Oil | Experimental | 6.6 g ALA (alpha-linolenic acid) per day |
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| Low-dose Fish Oil | Experimental | 1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day |
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| High-dose Fish Oil | Experimental | 3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day |
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| Placebo | Placebo Comparator | 4 g or 6 g soybean oil per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | Fish oil capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks |
| Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks. |
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Inclusion Criteria:Gender:
Central obesity as measured by waist circumference:
Men: Greater than 40 inches
Women: Greater than 35 inches
Men: Less than 40 mg/dL
Women: Less than 50 mg/dL
Blood pressure greater than or equal to 130/85 mmHg
Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation
Ability and willingness to give written informed consent
No known active psychiatric illness.
Exclusion Criteria:Daily intake of dietary supplements containing omega-3 FAs within the past month.
Fasting blood glucose > 140 mg/dL
Significant liver enzyme abnormality
AST or ALT more than 2 times the upper limit of normal and/or
Bilirubin more than 50% the upper limit of normal
Renal disease as measured at baseline:
Serum creatinine > 1.30 mg/dL, or
Calculated creatinine clearance < 71 mL/min
Self reported personal history of:
Subjects currently receiving the following medications (self report):
Body Mass Index (BMI) greater than or equal to 40.
Pregnant or Lactating
Inability to communicate effectively with study personnel
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Gardner | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22031659 | Result | Dewell A, Marvasti FF, Harris WS, Tsao P, Gardner CD. Low- and high-dose plant and marine (n-3) fatty acids do not affect plasma inflammatory markers in adults with metabolic syndrome. J Nutr. 2011 Dec;141(12):2166-71. doi: 10.3945/jn.111.142240. Epub 2011 Oct 26. |
| Label | URL |
|---|---|
| Study description and summary of results | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015228 | Hypertriglyceridemia |
| D007333 | Insulin Resistance |
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D008043 | Linseed Oil |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D010938 |
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| Flaxseed Oil |
| Dietary Supplement |
Flaxseed oil capsule |
|
| Placebo | Dietary Supplement | Soybean oil capsule |
|
Change was calculated as the value at 8 weeks minus the value at baseline
| Baseline and 8 weeks |
| Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks |
| Change from baseline in triglycerides at 8 weeks. | Change was calculated as the value at 8 weeks minus the value at baseline | Baseline and 8 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |