Abstract

BackgroundOverweight subjects easily develop alterations of the glucose and lipid metabolism and are exposed to an increased cardiometabolic risk. This condition is potentially reversible through the improvement of dietary and behavioural habits. However, a well-assembled nutraceutical would be a useful tool to better improve the metabolic parameters associated to overweight and insulin resistance.MethodsTo evaluate the effect of a combined nutraceutical containing berberine, chlorogenic acid and tocotrienols, we performed a double blind, cross-over designed trial versus placebo, in 40 overweight subjects with mixed hyperlipidaemia. After the first 8 weeks of treatment (or placebo), patients were asked to observe a 2-week washout period, and they were then assigned to the alternative treatment for a further period of 8 weeks. Clinical and laboratory data associated to hyperlipidaemia and insulin resistance have been obtained at the baseline, at the end of the first treatment period, after the washout, and again after the second treatment period.ResultsBoth groups experienced a significant improvement of anthropometric and biochemical parameters versus baseline. However, total cholesterol, LDL cholesterol, triglycerides, non-HDL cholesterol, fasting insulin, HOMA-IR, GOT and Lipid Accumulation Product decreased more significantly in the nutraceutical group versus placebo.ConclusionsThis combination seems to improve a large number of metabolic and liver parameters on the short-term in overweight subjects. Further studies are needed to confirm these observations on the middle- and long-term.

Highlights

  • Overweight subjects develop alterations of the glucose and lipid metabolism and are exposed to an increased cardiometabolic risk

  • No change has been observed after both treatments as it regards Diastolic Blood Pressure (DBP), Pulse Pressure (PP), Heart Rate (HR), Glutamic oxaloacetic transaminase (GOT), Hepatic Steatosis Index (HSI), creatinine and Serum Uric Acid (SUA) level

  • Both groups experienced a significant decrease in body weight, Body Mass Index (BMI) and waist circumference (p < 0.001), without

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Summary

Introduction

Overweight subjects develop alterations of the glucose and lipid metabolism and are exposed to an increased cardiometabolic risk. The main limitation in the clinical use of these products are the need to assume large quantities (for instance, cinnamon and bitter gourd), the scarce availability of clinical data (for instance, banaba), the relatively small metabolic effect (for instance, fibres and chromium), the need to use low doses in order to avoid side effects (for instance, berberine), and the cost (for instance, high quality green tea) [9]. Scarce data are available as it regards the clinical efficacy of combination of these substances In this context, the aim of our study was to evaluate the short-term metabolic effects of a combined nutraceutical containing berberine and chlorogenic acid on overweight subjects with mixed hyperlipidemia

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