NCT04767230 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO
Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008 Feb;27(1):65-74.
Edel AL, Rodriguez-Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, Guzman R, Aliani M, Pierce GN
Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. J Nutr. 2015 Apr;145(4):749-57. doi: 10.3945/jn.114.204594. Epub 2015 Feb 18.
Khandouzi N, Zahedmehr A, Mohammadzadeh A, Sanati HR, Nasrollahzadeh J
Effect of flaxseed consumption on flow-mediated dilation and inflammatory biomarkers in patients with coronary artery disease: a randomized controlled trial. Eur J Clin Nutr. 2019 Feb;73(2):258-265. doi: 10.1038/s41430-018-0268-x. Epub 2018 Aug 20.
Mandasescu S, Mocanu V, Dascalita AM, Haliga R, Nestian I, Stitt PA, Luca V
Flaxseed supplementation in hyperlipidemic patients. Rev Med Chir Soc Med Nat Iasi. 2005 Jul-Sep;109(3):502-6.

The Effect of a Healthy Diet Containing Flaxseed and Olive Oil Compared With Healthy Dietary Advice on Cardiovascular Disease Risk Markers in Patients With Coronary Artery Disease

Details for clinical trial NCT04767230

Clinical trial NCT04767230 - References