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Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

A Double Blind, Randomized, Placebo Controlled Trial of Flaxseed in Patients With Hypercholesterolemia

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00051415
Enrollment
60
Registered
2003-01-15
Start date
2003-01-31
Completion date
2005-01-31
Last updated
2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Flaxseed, Cholesterol

Brief summary

Flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing diet. The purpose of this study is to evaluate the safety and effectiveness of flaxseed in reducing high cholesterol.

Detailed description

Hypercholesterolemia is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). The National Cholesterol Education Program estimates that 65 million Americans with hypercholesterolemia could be treated with diet and exercise alone. Flaxseed is a potential component of cholesterol-reducing diet regimens. Flaxseed contains significant amounts of soluble fiber and is a rich source of both alpha-linolenic acid and phytoestrogenic ligands, which have been implicated in the prevention of ASCVD. However, flaxseed's phytoestrogenic ligands may have undesirable hormonal effects. This study will systematically evaluate the safety and efficacy of ground flaxseed ingestion in both men and women with hypercholesterolemia. Participants will be randomized to receive flaxseed or a matching wheat bran control. The test dose of flaxseed will be 40 grams administered in baked products (muffins, bread, or bars). The first 6 study weeks are a diet stabilization phase, followed by a 10-week study phase in which participants are expected to eat two servings of the test food daily. Blood and urine are collected for analysis, which will include measurement of low density lipoprotein cholesterol (LDL-C), post-prandial triglycerides, and urinary isoprostane secretion.

Interventions

BEHAVIORALFlaxseed-supplemented diet

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Men over 45 and post-menopausal women * LDL cholesterol \> 130 mg/dl

Exclusion criteria

* Established heart, kidney, or liver disease * Diabetes * Cancer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026