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The purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FishOil + placebo | Active Comparator | Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule |
|
| FishOil + CBE75 | Experimental | Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day) |
|
| FishOil + CBE150 | Experimental | Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FishOil | Dietary Supplement |
| ||
| CBE75 |
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol | Change in LDL cholesterol level at the end of 8 weeks | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Triglyceride | Change in triglyceride level at the end of 8 weeks. | Baseline, 8 weeks |
| oxLDL | Change in oxidized LDL level at the end of 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J Lamb, MD | MetaProteomics / Metagenics / FMRC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Functional Medicine Research Center | Gig Harbor | Washington | 98332 | United States |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary Supplement |
|
| CBE150 | Dietary Supplement |
|
| placebo | Dietary Supplement |
|
| Baseline, 8 weeks |
| Total cholesterol | Change in total cholesterol level at the end of 8 weeks. | Baseline, 8 weeks |
| HDL cholesterol | Change in HDL cholesterol level at the end of 8 weeks. | Baseline, 8 weeks |