Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

Tracking Information
First Submitted Date ICMJE	January 9, 2003
First Posted Date ICMJE	January 15, 2003
Last Update Posted Date	August 18, 2006
Study Start Date ICMJE	January 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00051415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Effectiveness of Flaxseed for Reducing High Cholesterol
Official Title ICMJE	A Double Blind, Randomized, Placebo Controlled Trial of Flaxseed in Patients With Hypercholesterolemia
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Hypercholesterolemia
Intervention ICMJE	Behavioral: Flaxseed-supplemented diet
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	60
Original Enrollment ICMJE	Same as current
Study Completion Date	January 2005
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria; Men over 45 and post-menopausal women; LDL cholesterol > 130 mg/dl Exclusion Criteria; Established heart, kidney, or liver disease; Diabetes; Cancer
Sex/Gender	Sexes Eligible for Study: All
Ages	45 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00051415
Other Study ID Numbers ICMJE	R21AT001291-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	National Center for Complementary and Integrative Health (NCCIH)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Philippe O Szapary, MD University of Pennsylvania
PRS Account	National Center for Complementary and Integrative Health (NCCIH)
Verification Date	July 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP