A Phase 2/3 interventional study of Flaxseed-supplemented diet in Hypercholesterolemia, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-08-18.
Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 2/3, Interventional, and Treatment
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 60 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.
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National Center for Complementary and Integrative Health (NCCIH)