Back to Search
Start Over
ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia.
- Source :
-
Nutrition (Burbank, Los Angeles County, Calif.) [Nutrition] 2016 Jul-Aug; Vol. 32 (7-8), pp. 767-76. Date of Electronic Publication: 2016 Jan 28. - Publication Year :
- 2016
-
Abstract
- Objective: Evidence suggests prolonged exposure to lower levels of low-density lipoprotein cholesterol (LDL-C), starting at a younger age, substantially lowers cardiovascular (CV) risk. Accordingly, the CV pandemic affecting younger population in low- to low-middle-income countries, where statin usage is poor even in secondary prevention, may benefit from lipid-lowering nutritional products, as nutritional intervention is generally preferred in these cultures. However, the safety and efficacy of such preparations have not been systematically tested.<br />Methods: In this multicenter, double-blind study, 191 statin-free subjects with newly-diagnosed hyperlipidemia (LDL-C >120 mg/dL, 3.11 mmol/L) and no evidence of CV disease were randomized to one capsule of a proprietary bioactive phytonutrient formulation containing red yeast rice, grape-seed, niacinamide, and folic acid (RYR-NS) or matched placebo twice daily, along with lifestyle modification, for 12 wk.<br />Results: Mean baseline LDL-C levels were 148.5 ± 24.0 mg/dL (3.85 ± 0.62 mmol/L) and 148.6 ± 21.9 mg/dL (3.85 ± 0.57 mmol/L) in the RYR-NS and placebo groups respectively. Compared with placebo, RYR-NS resulted in a significant reduction in LDL-C (-29.4% versus -3.5%, P < 0.0001) and non-high-density lipoprotein cholesterol (non-HDL-C; -29.8% versus -10.3%, P < 0.0001) at 12 wk. With RYR-NS, 43.4% individuals attained desirable LDL-C levels and 55.4% desirable non-HDL-C levels by week 12, compared to only 0% and 1.1%, respectively, at baseline. No safety issues were observed.<br />Conclusion: This study demonstrates the efficacy and safety of RYR-NS in lowering LDL-C and non-HDL-C after 12 wk, with magnitude of LDL-C reduction being comparable to that seen with moderate-intensity statin therapy. Further long-term studies are required to determine the impact of RYR-NS on treatment adherence and clinical outcomes.<br /> (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adolescent
Adult
Aged
Anticholesteremic Agents blood
Anticholesteremic Agents therapeutic use
Biological Products blood
Cardiovascular Diseases blood
Double-Blind Method
Female
Humans
Hyperlipidemias blood
Lipids blood
Male
Middle Aged
Treatment Outcome
Young Adult
Biological Products therapeutic use
Cardiovascular Diseases prevention & control
Dietary Supplements
Hyperlipidemias drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1873-1244
- Volume :
- 32
- Issue :
- 7-8
- Database :
- MEDLINE
- Journal :
- Nutrition (Burbank, Los Angeles County, Calif.)
- Publication Type :
- Academic Journal
- Accession number :
- 27143594
- Full Text :
- https://doi.org/10.1016/j.nut.2016.01.012