Safety and Effectiveness of Flaxseed for Reducing High Cholesterol

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051415
• Other study ID #: R21AT001291-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 9, 2003
• Last updated: August 17, 2006
• Start date: January 2003
• Est. completion date: January 2005

Study information

• Verified date: July 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria

• Men over 45 and post-menopausal women

• LDL cholesterol > 130 mg/dl

Exclusion Criteria

• Established heart, kidney, or liver disease

• Diabetes

• Cancer

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Behavioral:
• Flaxseed-supplemented diet

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,