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| Name | Class |
|---|---|
| Archer Daniels Midland Co. | INDUSTRY |
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Purpose: To demonstrate the efficacy of Beneflaxâ„¢ flaxseed lignan (SDG) concentrate to lower serum cholesterol levels.
Background: Flaxseed has been studied for various health benefits in humans, including prostate health, glucose control, and cardiovascular health. Cholesterol levels and high blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has had variable effects on serum lipid levels, perhaps a consequence of variations in the amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making the study of this bioactive compound difficult.
Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo pill, diet counseling to comply with NCEP Step I diet |
|
| 150 mg/day Beneflax | Experimental | 2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks |
|
| 300 mg/day Beneflax | Experimental | 2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| secoisolariciresinol diglucoside-containing extract of flaxseed | Dietary Supplement | 0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum total cholesterol from baseline to 12 weeks after intervention treatments | 12 weeks | |
| Change in serum glucose from baseline to 12 weeks after intervention treatments | 12 weeks | |
| Change in blood pressure from baseline to end of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum clinical chemistry from baseline to end of treatment | serum uric acid, BUN, Na, K, Cl, Ca, P, LDH, AST, ALT, bilirubin, carbon dioxide | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Hendrich, PhD | Iowa State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition & Wellness Research Center | Ames | Iowa | 50011 | United States |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| D009750 |
| Nutritional and Metabolic Diseases |