Effect of Dietary Supplementation with a Natural Extract of Sclerocarya birrea on Glycemic Metabolism in Subjects with Prediabetes: A Randomized Double-Blind Placebo-Controlled Study.

Desirée Victoria-Montesinos,Maravillas Sánchez-Macarro,Enrique Bernal-Morell,María Salud Abellán-Ruiz,Francisco Javier López-Román,José Antonio Gabaldón-Hernández,María Querol-Calderón,Vicente Ávila-Gandía,Antonio J Luque-Rubia

doi:10.3390/nu13061948

Abstract

A randomized, double-blind, placebo-controlled study was conducted with the primary objective of assessing the effect of a natural extract of Sclerocarya birrea on glucose metabolism in subjects with prediabetes. The duration of the study was 90 days. Thirty-three subjects assigned to the experimental group (daily ingestion of 100 mg of the nutraceutical product) and 34 assigned to the placebo group completed the study. There were 36 men and 31 women with a mean age of 32.3 ± 14.1 years. In the area under the curve (AUC) of the oral glucose tolerance test (OGTT), statistically significant decreases in the experimental group at 40 and 90 days as compared with baseline were found, whereas significant changes in the placebo group were not observed. Within-group differences were statistically significant in favor of the experimental group for glucose peak at OGTT, serum insulin, insulin resistance markers, and flow-mediated dilation. Changes in lipid and anthropometric parameters were not observed, although there was a trend for lower cholesterol levels and a decrease in body weight in the experimental group. Decreases in systolic blood pressure were also higher among subjects in the experimental group. This exploratory study confirms the antidiabetic activity of Sclerocarya birrea in prediabetes. Further studies using better measurements of beta-cell function are needed to clarify the underlying mechanisms of the hypoglycemic effect of this natural compound.

Highlights

The primary objective of this exploratory study was to assess the effect of a 90-day daily regimen with a dietary nutraceutical supplement based on a natural extract of Sclerocarya birrea on the control of glucose metabolism in subjects diagnosed with prediabetes
(35 to each group), but total The of 105 voluntary were excluded because the study inclusion criteria two subjects to the experimental group and one assigned to the placebo group were not met.assigned
The administration for 90 days of a nutraceutical product based on a natural extract of Sclerocarya birrea in subjects diagnosed with prediabetes was associated with an improvement of the area under the curve (AUC) during oral glucose tolerance test (OGTT), measured using either the basal glycemia or at 0 mg/dL

Summary

Introduction

Prediabetes is an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold. The specific parameters included in the criteria for the definition of prediabetes are not uniform, with impaired glucose tolerance (IGT) of. 140–199 mg/dL after ingestion of 75 g of oral glucose load, impaired fasting glucose (IFG). According to the American Diabetes Association (ADA), relying on one test may underestimate the prevalence of prediabetes [1]. Prediabetes is increasingly recognized as an important metabolic state, predisposing individuals to progression to overt type 2 diabetes (25% of subjects within 3–5 years and as many as 70% within their lifetime) [3] and diabetes-associated complications, such as diabetic retinopathy, neuropathy, nephropathy, and cardiovascular disease [4,5].

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