Francesco Rozza1,2, Valentina Trimarco1,3, Raffaele Izzo4,5, Davide Grassi6, Claudio Ferri6. 1. Hypertension Research Center (CIRIAPA), Federico II University, Naples, Italy. 2. Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy. 3. Department of Neurosciences, Federico II University, Naples, Italy. 4. Hypertension Research Center (CIRIAPA), Federico II University, Naples, Italy. raffaele.izzo@unina.it. 5. Department of Translational Medical Sciences, Federico II University, Via S. Pansini 5, Building 2, Naples, 80131, Italy. raffaele.izzo@unina.it. 6. Department of Medicine, Life and Environmental Sciences, L'Aquila University, Coppito, Italy.
Abstract
INTRODUCTION: Asymptomatic hyperuricemia is not a current indication for therapy as the definite role of serum uric acid elevation as a cardiovascular risk factor is extremely likely but still controversial. AIM: We designed a double blind, placebo-controlled, randomized study to assess the effects of a combination of nutraceuticals (ZinutriK®, containing a fixed combination of kampferol, baicalin, caffeine, and rutin) on serum uric acid levels, lipid variables and the global cardiovascular risk profile. METHODS:Sixteen individuals (mean age 59.0 ± 11.9 years, 4 women) with asymptomatic hyperuricemia completed the study. RESULTS: ZinutriK® treatment (4 weeks) reduced serum uric acid concentrations (from 7.9 + 0.9 to 7.0 + 0.7 mg/dL) when compared to both baseline and placebo (p < 0.006 and p < 0.001, respectively). Compared to both placebo and baseline, the same fixed combination of nutraceuticals also reduced circulating LDL cholesterol and increased HDL cholesterol concentrations within 4 weeks (p < 0.001 or less), thereby improving the Framingham risk score (p < 0.001 or less). Neither minor nor major side effects were observed. CONCLUSIONS: This study represents the first demonstration that a short-term therapy with a fixed combination of different natural substances can significantly reduce serum uric acid concentrations in asymptomatic hyperuricemic patients, with no side effects and a significant improvement in the lipid pattern and then in the global cardiovascular risk profile.
RCT Entities:
INTRODUCTION: Asymptomatic hyperuricemia is not a current indication for therapy as the definite role of serum uric acid elevation as a cardiovascular risk factor is extremely likely but still controversial. AIM: We designed a double blind, placebo-controlled, randomized study to assess the effects of a combination of nutraceuticals (ZinutriK®, containing a fixed combination of kampferol, baicalin, caffeine, and rutin) on serum uric acid levels, lipid variables and the global cardiovascular risk profile. METHODS: Sixteen individuals (mean age 59.0 ± 11.9 years, 4 women) with asymptomatic hyperuricemia completed the study. RESULTS: ZinutriK® treatment (4 weeks) reduced serum uric acid concentrations (from 7.9 + 0.9 to 7.0 + 0.7 mg/dL) when compared to both baseline and placebo (p < 0.006 and p < 0.001, respectively). Compared to both placebo and baseline, the same fixed combination of nutraceuticals also reduced circulating LDL cholesterol and increased HDL cholesterol concentrations within 4 weeks (p < 0.001 or less), thereby improving the Framingham risk score (p < 0.001 or less). Neither minor nor major side effects were observed. CONCLUSIONS: This study represents the first demonstration that a short-term therapy with a fixed combination of different natural substances can significantly reduce serum uric acid concentrations in asymptomatic hyperuricemicpatients, with no side effects and a significant improvement in the lipid pattern and then in the global cardiovascular risk profile.
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