A multicenter study of nutraceutical drinks for cholesterol (evaluating effectiveness and tolerability)
Abstract
Background We hypothesized that a nutraceutical formulation containing small amounts of bioactive constituents that exert cholesterol-lowering effects by different mechanisms may exhibit synergistic efficacy with a clean tolerability profile. The purpose of this study was to evaluate nutraceutical fruit-flavored drinks with and without red yeast rice (RYR) for effects on low-density lipoprotein (LDL) and total cholesterol.Methods In double-blinded fashion, 79 subjects were randomized to one of three fruit-flavored drinks, ie, a placebo, and two active drinks containing niacin, phytosterol esters, L-carnitine, vitamin C, and Co-Q-10, one with and without RYR, twice daily. Primary end points were LDL and total cholesterol percent reductions from baseline. Secondary end points were high-density lipoprotein and C-reactive protein percent change from baseline. Physician contact and laboratory work were obtained at baseline, 4 weeks, and 8 weeks of subject participation.Results A total of 59 subjects completed the study. The placebo group and the group receiving the nutraceuticals without RYR showed no change in primary or secondary end points. The nutraceutical drink with RYR reduced total cholesterol at week 4 by 13% (-35 mg/dL) and week 8 by 14% (-46 mg/dL). LDL cholesterol decreased 17.1% at 4 weeks (-28 mg/dL) and 17.8% at week 8 (-30 mg/dL). In the effective drink arm containing nutraceuticals and RYR there were no biochemical or subjective intolerance, with the exception of one subject who experienced headache.Conclusions A nutraceutical drink with RYR can be a safe and effective natural alternative to pharmacologic therapies for people intolerant to or refusing statins but still in need of achieving and maintaining a healthy and low cholesterol level.
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For all previously mentioned studies, there were no safety concerns.
“For all previously mentioned studies, there were no safety concerns (80,126-130).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [127]
Red yeast rice has been used as an alternative to statin therapy in treating patients with mild to moderate hypercholesterolemia, particularly in those considered statin intolerant, and clinical studies suggest red yeast rice is well tolerated, safe, and effective for cardiovascular disease primary prevention.
“RYR has been used as an alternative to statin therapy in treating patients with mild to moderate hypercholesterolemia, particularly in those considered to be statin intolerant, and clinical studies suggest that RYR is well tolerated, safe, and effective for CVD primary prevention (126-128).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [127]
Some nutraceuticals can enhance or potentially replace statin action.
“some nutraceuticals are then able to enhance (126,127,135-137,145-147) or potentially replace the action of statins (63-66,50-52,58,168,169).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [127]
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- Authors
- Karl, M., Rubenstein, M., Rudnick, C., & Brejda, J.
- Affiliations
- Florida Atlantic University (US)
- Miami Children's Hospital (US)
- Lincoln University - California (US)
- Corresponding author
- Karl, Mitchell
- Venue
- Journal of clinical lipidology
- Publisher
- Elsevier BV
- Published
- 2012-03
- Volume
- 6
- Issue
- 2
- Pages
- 150-158
- ISSN
- 1876-4789 (ISSN-L)
- 1933-2874
- OpenAlex
- W2047499561
- Cited by
- 21
- References
- 35
- Citations by year
- 2026: 1 · 2023: 3 · 2022: 3 · 2020: 1 · 2019: 2 · 2018: 3 · 2017: 1 · 2016: 1 · 2015: 2 · 2014: 1 · 2013: 3
- FWCI
- 1.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of clinical lipidology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Keywords
- red yeast rice, cholesterol lowering, LDL cholesterol, total cholesterol, nicotinic acid, phytosterol esters, L-carnitine, vitamin C, tolerability, statin intolerance, HDL cholesterol, C-reactive protein
- MeSH terms
- Adult, Aged, Aged, 80 and over, Anticholesteremic Agents, Beverages, Biological Products, Chemistry, Pharmaceutical, Cholesterol, Demography, Humans, Lipoproteins, LDL, Male, Middle Aged, Surveys and Questionnaires, Dietary Supplements, Endpoint Determination, Young Adult
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