Flax Lignans and Heart Health (ISULignan)

Iowa State University

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01314586

ADM Beneflax ISU-1

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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93 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo pill, diet counseling to comply with NCEP Step I diet

Treatment:

Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed

150 mg/day Beneflax

Experimental group

Description:

2 pills taken at breakfast and dinner containing a total of 150 mg secoisolariciresinol (SDG) per day for 12 weeks

Treatment:

Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed

300 mg/day Beneflax

Experimental group

Description:

2 pills taken at breakfast and dinner containing a total of 300 mg secoisolariciresinol (SDG) per day for 12 weeks

Treatment:

Dietary Supplement: secoisolariciresinol diglucoside-containing extract of flaxseed