Elsevier

Nutrition

Volume 32, Issues 7–8, July–August 2016, Pages 767-776
Nutrition

Applied nutritional investigation
ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia

https://doi.org/10.1016/j.nut.2016.01.012Get rights and content
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open access

Highlights

  • Prolonged exposure to lower low-density lipoprotein cholesterol (LDL-C) is perhaps the most effective modifiable risk factor in reduction of cardiovascular (CV) events.

  • Although statins are highly effective, their usage remains poor, especially in low- to low-middle-income countries.

  • Nutritional supplements, being culturally more acceptable, are a potential solution but have not been systematically tested.

  • Our study, ESSENS, was the first randomized study evaluating efficacy and safety of a lipid-lowering nutritional supplement in India.

  • 191 statin-free subjects with newly-diagnosed hyperlipidemia and no evidence of CV disease were randomized to one capsule of a proprietary nutritional supplement containing red yeast rice, grape-seed, niacinamide, and folic acid or matched placebo twice daily.

  • 12 wk treatment with the supplement resulted in ∼30% reduction in LDL-C with no apparent safety issues.

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.

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.

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.

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.

Keywords

Primary prevention
Lipid-lowering
Nutritional intervention

Cited by (0)

The authors are grateful to I5 Clinical Research Pvt. Ltd., Chennai, India, for supervising the study and providing administrative, technical, and material support. This study was supported by a research grant from Preemptive Meds Inc, USA, and Abbott Established Pharmaceuticals Division, India. This was an investigator-initiated study. The funding agencies had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the manuscript for publication.