Flax Lignans and Heart Health

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed

• Registration Number: NCT01314586
• Lead Sponsor: Iowa State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-07
• Study Completion: 2009-11
• Status Verified: 2011-03
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-11
• Last Update Submitted: 2011-03-11
• Study First Posted: 2011-03-14
• Last Update Posted: 2011-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
150 mg/day Beneflax	secoisolariciresinol diglucoside-containing extract of flaxseed	2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks
300 mg/day Beneflax	secoisolariciresinol diglucoside-containing extract of flaxseed	2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks
placebo	secoisolariciresinol diglucoside-containing extract of flaxseed	placebo pill, diet counseling to comply with NCEP Step I diet

Primary Outcome Measures

Name	Time	Method
Change in serum total cholesterol from baseline to 12 weeks after intervention treatments	12 weeks
Change in blood pressure from baseline to end of treatment	12 weeks
Change in serum glucose from baseline to 12 weeks after intervention treatments	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nutrition & Wellness Research Center; 🇺🇸 Ames, Iowa, United States