Nutraceutical Effects on Glucose and Lipid Metabolism in Patients with Impaired Fasting Glucose: A Pilot, Double-Blind, Placebo-Controlled, Randomized Clinical Trial on a Combined Product

Arrigo Francesco Giuseppe Cicero, Federica Fogacci, Martino Morbini, Alessandro Colletti, Marilisa Bove, Maddalena Veronesi, Marina Giovannini, Claudio Borghi, Arrigo Francesco Giuseppe Cicero, Federica Fogacci, Martino Morbini, Alessandro Colletti, Marilisa Bove, Maddalena Veronesi, Marina Giovannini, Claudio Borghi

Abstract

Introduction: A number of natural compounds have individually demonstrated to improve glucose and lipid levels in humans.

Aim: To evaluate the short-term glucose and lipid-lowering activity in subjects with impaired fasting glucose.

Methods: To assess the effects of a combination of nutraceuticals based on Lagerstroemia speciosa, Berberis aristata, Curcuma longa, Alpha-lipoic acid, Chrome picolinate and Folic acid, we performed a double-blind, parallel group, placebo-controlled, randomized clinical trial in 40 adults affected by impaired fasting glucose (FPG = 100-125 mg/dL) in primary prevention of cardiovascular disease. After a period of 2 weeks of dietary habits correction only, patients continued the diet and began a period of 8 weeks of treatment with nutraceutical or placebo. Data related to lipid pattern, insulin resistance, liver function and hsCRP were obtained at the baseline and at the end of the study.

Results: No side effects were detected in both groups of subjects. After the nutraceutical treatment, and compared to the placebo-treated group, the enrolled patients experienced a significant improvement in TG (-34.7%), HDL-C (+13.7), FPI (-13.4%), and HOMA-Index (-25%) versus the baseline values. No significant changes were observed in the other investigated parameters in both groups (Body Mass Index, LDL-C, hsCRP).

Conclusions: The tested combination of nutraceuticals showed clinical efficacy in the improvement of TG, HDL-C, FPI and HOMA-Index, with an optimal tolerability profile. Further confirmation is needed to verify these observations on the middle and long term with a larger number of subjects.

Keywords: Impaired fasting glucose; Insulin-sensitivity; Metabolic syndrome; Nutraceuticals.

Conflict of interest statement

Conflict of interest

No one of the authors has a direct conflict of interest in the publication of this paper.

Ethical approval

The trial was approved by the local Ethical Board.

Informed consent

All the enrolled patients signed and informed consent form.

Figures

Fig. 1
Fig. 1
Effect of the tested combined nutraceutical on fasting plasma glucose and HOMA index (*p < 0.05 vs. baseline)

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Source: PubMed

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