The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed. Target sample size is 60.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
69
1 g of Zein nanoencapsulated daily
1 g of Zein non-encapsulated daily
Centro de Investigacion en Nutricion. Universidad de Navarra
Pamplona, Navarre, Spain
Change in Fructosamine
Change in the levels of Fructosamine From day 0 to day 28
Time frame: 28 days
Change in GLP-1 AUC
Change in AUC of postprandial GLP-1 levels after OGTT
Time frame: Baseline, 15, 30, 45 and 60 minutes
Fasting Plasma glucose
Change in Fasting Plasma glucose from day 0 to day 28
Time frame: 28 days
Continuous glucose levels
Area under the curve of 28 days of plasma glucose levels
Time frame: 28 days
Insulin Levels
Change in Fasting insulin levels from day 0 to day 28
Time frame: 28 days
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