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The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
This is a randomized, placebo-controlled, double-blind, crossover study of the effects of EPA and DHA on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. The study will characterize the effects of EPA alone and DHA alone, relative to each other and to placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene expression, and plasma lipid and lipoprotein levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA intervention | Experimental | Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks. |
|
| DHA intervention | Experimental | Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks. |
|
| Placebo | Placebo Comparator | 3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA | Dietary Supplement | 10 week supplementation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 (IL-6) | plasma levels in pg/mL | 10 weeks |
| Tumor Necrosis Factor Alpha (TNF-alpha) | plasma levels in pg/mL | 10 weeks |
| Low Density Lipoprotein Cholesterol (LDL-C) | plasma levels in mg/dL | 10 weeks |
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Inclusion criteria:
fasting plasma TG levels between 150 and 500 mg/dL
C-reactive protein (CRP) levels ≥2 µg/mL
at least one of the following criteria for the definition of metabolic syndrome:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefania Lamon-Fava, PhD | Tufts University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts | 02111 | United States |
The objective of this study is to provide critical information regarding both common and distinctive roles of the omega-3 fatty acids EPA and DHA in systemic inflammation and lipid metabolism.
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24 subjects met the inclusion criteria and were enrolled into the study. 3 subjects dropped off during the placebo lead-in phase of the study
405 subjects were screened for eligibility at the Metabolic Research Unit of the Human Nutrition Research Center on Aging at Tufts Unoversity
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then EPA, Then DHA | 3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure EPA for 10 weeks; then washout of 10 weeks; then pure DHA 3000 mg/day Placebo and EPA and DHA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening |
| FG001 | Placebo, Then DHA, and Then EPA | 3000 mg high oleic acid sunflower oil/day during 4-week lead-in phase; then participants received 3000 mg pure DHA for 10 weeks; then washout of 10 weeks; then pure EPA 3000 mg/day Placebo and DHA and EPA capsules provided as 750 mg/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo lead-in Phase |
|
| ||||||||||||||||||
| First Active Intervention |
| |||||||||||||||||||
| Second Active Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Baseline characteristic, defined as end of lead-in phase |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | years, continuous variable |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interleukin-6 (IL-6) | plasma levels in pg/mL | Posted | Mean | Standard Deviation | pg/mL | 10 weeks |
|
adeverse events were collected during the participation of study subjects, equivalent to 34 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EPA Intervention | Subjects randomized to receive 3000 mg EPA/day, provided as EPA 750 mg/capsule will be instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks. EPA: 10 week supplementation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gout | Metabolism and nutrition disorders | Non-systematic Assessment | subjects experienced left ankle swelling 4 days after starting placebo lead in phase |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stefania Lamon-Fava, Scientist I | Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | 617-556-3105 | stefania.lamon-fava@tufts.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2018 | Feb 11, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| DHA | Dietary Supplement | 10 week supplementation |
|
| sunflower oil | Dietary Supplement | 4-week lead-in |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| C reactive protein | Mean | Standard Deviation | microg/mL |
|
| Glucose | Mean | Standard Deviation | mg/dL |
|
| triglycerides | Mean | Standard Deviation | mg/dL |
|
| OG002 |
| DHA Intervention |
Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks. DHA: 10 week supplementation |
|
|
|
| Primary | Tumor Necrosis Factor Alpha (TNF-alpha) | plasma levels in pg/mL | Posted | Mean | Standard Deviation | pg/mL | 10 weeks |
|
|
|
|
| Primary | Low Density Lipoprotein Cholesterol (LDL-C) | plasma levels in mg/dL | Posted | Mean | Standard Deviation | mg/dL | 10 weeks |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | DHA Intervention | Subjects randomized to 3000 mg DHA/day provided as DHA 750 mg/capsule will instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals for 10 weeks. DHA: 10 week supplementation | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Placebo | 3000 mg high oleic acid sunflower oil/day; 750 mg high oleic acid sunflower oil/capsule; subjects instructed to take 2 capsules by mouth in the morning and 2 in the evening with meals during 4 week long lead-in phase. sunflower oil: 4-week lead-in | 0 | 21 | 0 | 21 | 1 | 21 |
|
| hypertension | Cardiac disorders | Non-systematic Assessment | subjects had blood pressure 177/80 at visit |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| mean difference, log transformed values |
| Superiority |
| Mixed Models Analysis | 0.83 | mean differences, log transformed values | Superiority |
| 0.005 |
| mean difference |
| Superiority |
| Mixed Models Analysis | 0.17 | Superiority |