Flax Lignans and Heart Health

Iowa State University93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in serum total cholesterol from baseline to 12 weeks after intervention treatments

Time frame: 12 weeks

Change in serum glucose from baseline to 12 weeks after intervention treatments

Time frame: 12 weeks

Change in blood pressure from baseline to end of treatment

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

Flax Lignans and Heart Health

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes