Flax Lignans and Heart Health

Study Overview
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Brief Summary
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Purpose: To demonstrate the efficacy of Beneflax™ 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.

Official Title
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Iowa State Study on Flax Lignans and Heart Health

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men, 40-65 yrs/old, postmenopausal women 50-65 yrs/old not > 5 yrs post menopause. All subjects were hypercholesterolemic with either total cholesterol >240 mg/dl and < 320 mg/dL or LDL cholesterol >140 mg/dl and <190 mg/dl at the screening visit. Exclusion Criteria: Excluded subjects included diabetics, people being actively treated with niacins, fibrates, statins, insulin, ACE inhibitors or other cholesterol/ blood pressure pharmaceutical treatments, people who consumed large amounts of soy, flax, rye breads, pumpkin seeds, hydrolyzed milk products, sterols, and/or berries (strawberries/blueberries) or supplements aimed at cholesterol reduction such as spruce lignans, sytrinol (poly methoxylated flavanols), polycosinols, people consuming flaxseed on a regular basis.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo pill, diet counseling to comply with NCEP Step I diet | Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed<br>* 0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet<br>* Other names: Beneflax;|
| Experimental: 150 mg/day Beneflax<br>2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks | Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed<br>* 0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet<br>* Other names: Beneflax;|
| Experimental: 300 mg/day Beneflax<br>2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks | Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed<br>* 0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet<br>* Other names: Beneflax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercholesterolemia, postmenopause, secoisolariciresinol diglucoside, flaxseed, lignans, enterolactone, enterodiol, serum cholesterol, LDL cholesterol