Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00051415
Recruitment Status : Completed
First Posted : January 15, 2003
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

January 9, 2003
January 15, 2003
August 18, 2006
January 2003
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Complete list of historical versions of study NCT00051415 on Archive Site
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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
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.

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.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Behavioral: Flaxseed-supplemented diet
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2005
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Inclusion Criteria

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

Exclusion Criteria

  • Established heart, kidney, or liver disease
  • Diabetes
  • Cancer
Sexes Eligible for Study: All
45 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R21AT001291-01( U.S. NIH Grant/Contract )
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National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Philippe O Szapary, MD University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP