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Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier:
NCT00051415
First received: January 9, 2003
Last updated: August 17, 2006
Last verified: July 2006
History of Changes

January 9, 2003
August 17, 2006
January 2003
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Complete list of historical versions of study NCT00051415 on ClinicalTrials.gov 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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypercholesterolemia
Behavioral: Flaxseed-supplemented diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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
Both
45 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051415
R21AT001291-01
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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