Flax Lignans and Heart Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Once-Daily Oral Dose of BeneFlax to Healthy Older Adults

NCT01846117

Oxidative Stress Inflammation Aging +1 more

COMPLETED PHASE1/PHASE2

Exercise and Flax-Based Nutritional Supplementation for Lowering Cholesterol

NCT00204412

Metabolic Syndrome Osteoporosis

COMPLETED PHASE3

Single Oral Dose of BeneFlax to Healthy Young and Older Adults

NCT01531569

Diabetes Mellitus, Type 2 Hypercholesterolemia

COMPLETED PHASE2

The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans (CardioFlax Study).

NCT04179136

Healthy Volunteers

COMPLETED NA

Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease

NCT00781950

Peripheral Arterial Disease

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

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

Group Type PLACEBO_COMPARATOR

secoisolariciresinol diglucoside-containing extract of flaxseed

Intervention Type DIETARY_SUPPLEMENT

0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet

150 mg/day Beneflax

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

Group Type EXPERIMENTAL

secoisolariciresinol diglucoside-containing extract of flaxseed

Intervention Type DIETARY_SUPPLEMENT

0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet

300 mg/day Beneflax

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

Group Type EXPERIMENTAL

secoisolariciresinol diglucoside-containing extract of flaxseed

Intervention Type DIETARY_SUPPLEMENT

0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

secoisolariciresinol 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Beneflax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No