Flax Lignans and Heart Health (ISULignan)

I

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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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