Hypercholesterolemia
Conditions
Keywords
hypercholesterolemia, postmenopause, secoisolariciresinol diglucoside, flaxseed, lignans, enterolactone, enterodiol, serum cholesterol, LDL cholesterol
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTsecoisolariciresinol diglucoside-containing extract of flaxseed
0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet
Sponsors
Archer Daniels Midland Co.
Iowa State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum clinical chemistry from baseline to end of treatment | 12 weeks | serum uric acid, BUN, Na, K, Cl, Ca, P, LDH, AST, ALT, bilirubin, carbon dioxide |
Countries
United States
Outcome results
None listed