A placebo-controlled trial of a proprietary lipid-lowering nutraceutical supplement in the management of dyslipidemia. 2016

M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
Hypertension Institute of Nashville, Saint Thomas Hospital, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.

There is an ever growing emergence in the popularity of patient-driven care. As this health and wellness model grows, inquiries into diet, lifestyle, and supplemental approaches will continue to become a focal point for the healthcare consumer. Because of this, the aim of this study is to determine the tolerability, and overall effectiveness of a proprietary multi-ingredient lipid-lowering supplement in subjects with dyslipidemia. Forty participants were recruited for a single-center, double-blind randomized, placebocontrolled trial. Study participants were recruited between December 2014 and March 2015. Initial screening included a physical examination, renal and hepatic function, serum lipid, serum electrolytes, complete blood counts, and urine analysis. The 40 participants were randomly assigned to receive either the proprietary multi-ingredient lipid-lowering supplement (PMILLS) n= 20 or placebo n= 20. The trial consisted of a screening visit, a two-week run-in, and a four-month treatment period. Samples were taken at baseline, one month and four months of treatment. Results from the trial showed that the PMILLS significantly reduced total cholesterol (TC), low density lipoprotein (LDL-C), very low density lipoprotein (VLDL-C), oxidized LDL (oxLDL), Apo-lipoprotein B, triglycerides (TG), LDL particle number (LDL-P), heart rate, and diastolic blood pressure compared to placebo at one month and four months. The PMILLS significantly increased high density lipoprotein (HDL) particle number (HDL-P), and low density lipoprotein (LDL) particle size from dense type III and IV to larger type I and II LDL particle, compared to placebo at one month and four months. In addition, the PMILLS significantly reduced high sensitivity C-reactive protein (hs-CRP), tumor necrosis alpha (TNF-α), and interleukin 6 (IL-6) within the treatment group from baseline. There were no adverse effects noted in the treatment group after four months of supplementation. The present study demonstrates this PMILLS improves all relevant lipid parameters, such as particle numbers and particles sizes, as well as showing a significant reduction in inflammatory markers linked to cardiovascular health. With such combined changes in lipids, lipid sub-fractions, and inflammation, which are considered among the most effective means of reducing coronary heart disease (CHD), this PMILLS represents a new addition to safe and effective lipid-modifying strategies.

UI MeSH Term Description Entries
D008076 Cholesterol, HDL Cholesterol which is contained in or bound to high-density lipoproteins (HDL), including CHOLESTEROL ESTERS and free cholesterol. High Density Lipoprotein Cholesterol,Cholesterol, HDL2,Cholesterol, HDL3,HDL Cholesterol,HDL(2) Cholesterol,HDL(3) Cholesterol,HDL2 Cholesterol,HDL3 Cholesterol,alpha-Lipoprotein Cholesterol,Cholesterol, alpha-Lipoprotein,alpha Lipoprotein Cholesterol
D008078 Cholesterol, LDL Cholesterol which is contained in or bound to low density lipoproteins (LDL), including CHOLESTEROL ESTERS and free cholesterol. LDL Cholesterol,Cholesteryl Linoleate, LDL,LDL Cholesteryl Linoleate,Low Density Lipoprotein Cholesterol,beta-Lipoprotein Cholesterol,Cholesterol, beta-Lipoprotein,beta Lipoprotein Cholesterol
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D014280 Triglycerides An ester formed from GLYCEROL and three fatty acid groups. Triacylglycerol,Triacylglycerols,Triglyceride

Related Publications

M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
October 2012, The Annals of pharmacotherapy,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
January 1976, Proceedings of the Royal Society of Medicine,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
August 2015, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
January 2024, Journal of integrative medicine,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
January 2015, The journal of headache and pain,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
August 2023, Heliyon,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
February 1999, The American journal of clinical nutrition,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
December 2016, Journal of pediatric gastroenterology and nutrition,
M Houston, and R Rountree, and J Lamb, and S Phipps, and S Meng, and B Zhang
November 2006, American heart journal,
Copied contents to your clipboard!