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Cholestin Clinical Study from PubMed

A study was published in this month's issue of the Journal Nutrition, titled "A Pilot Study of the Safety and Efficacy of Cholestin in Treating HIV-Related Dyslipidemia." The study was conducted by the Rush University College of Nursing in Chicago, Illinois. The researchers concluded that after eight weeks, Cholestin (with red yeast rice) significantly lowered total and low-density lipoprotein (LDL) cholesterol (12% and 23%, respectively) in patients with dyslipidemia related to human immunodeficiency virus (HIV).


Reference: Keithley JK, et al. Nutrition 2002;18(2):201-204.

A pilot study of the safety and efficacy of cholestin in treating HIV-related dyslipidemia.

Keithley JK, Swanson B, Sha BE, Zeller JM, Kessler HA, Smith KY.

Rush University College of Nursing, Chicago, Illinois, USA

OBJECTIVE: We collected preliminary safety and efficacy data on the effects of Cholestin, a statin-containing dietary supplement, in individuals with dsylipidemia related to human immunodeficiency virus.

METHODS: Fourteen adults with dsylipidemia related to human immunodeficiency virus characterized by hypercholesterolemia, hypertriacylglycerolemia, or both participated in a randomized, double-blind, placebo-controlled pilot study in an infectious disease clinic based in an academic medical center. Participants were randomly assigned to receive 1.2 g of Cholestin twice daily (n = 7) or placebo (n = 7) for 8 wk. The main outcome measures were safety (hepatic function tests, plasma human immunodeficiency virus-1 RNA levels, CD4(+) cell counts, adverse effects) and efficacy (fasting serum cholesterol: total, high- and low-density lipoproteins, and fasting serum triacylglycerols). Safety and efficacy outcomes were evaluated at 2- and 8-wk intervals.

RESULTS: Twelve participants (n = 6 per group) completed the 8-wk treatment protocol. After 8 wk of treatment with Cholestin, there were significant declines from baseline in mean ([plus minus] standard error of the mean) fasting total cholesterol ([minus sign]30.8 [plus minus] 8.8 versus 7.7 [plus minus] 5.6; P = 0.01) and low-density lipoprotein cholesterol ([minus sign]32.2 [plus minus] 7.2 versus 26.3 [plus minus] 14.2; P = 0.01) versus placebo. Moreover, the decline in fasting total cholesterol was significant ([minus sign]40.2 [plus minus] 4.8 versus 2.8 [plus minus] 11.9; P = 0.006) after 2 wk of therapy, at which time the low-density lipoprotein cholesterol approached significance ([minus sign]30.2 [plus minus] 7.4 versus 4.4 [plus minus] 15.2; P = 0.068). High-density lipoprotein cholesterol and triacylglycerol levels did not change at either time point. No adverse effects were seen with Cholestin.

CONCLUSIONS: Cholestin may safely lower total and low-density lipoprotein cholesterol in patients with dsylipidemia related to human immunodeficiency virus. Larger and longer-term trials of this approach are warranted.

PMID: 11844656 [PubMed - as supplied by publisher]

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