Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

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ClinicalTrials.gov Identifier: NCT00051415

Recruitment Status : Completed

First Posted : January 15, 2003

Last Update Posted : August 18, 2006

Sponsor:

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

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

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

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 ^ICMJE

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 ^ICMJE

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

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

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 ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

45 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

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 ^ICMJE

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

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