Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051415
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-01-09
Brief Title:
Safety and Effectiveness of Flaxseed for Reducing High Cholesterol
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
A Double Blind Randomized Placebo Controlled Trial of Flaxseed in Patients With Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 flaxseeds 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None