Zein Nanoparticles for Glycemic Control

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Zein Nanoparticles for Glycemic Control

Conditions
-----------------
PreDiabetes, Overweight and Obesity, Adult ALL

Intervention / Treatment
-----------------
* Dietary Supplement: Zein nanocapsules
* Dietary Supplement: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight or obesity (BMI between 25 and 40 kg/m2 Presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dL) No weight variations considered relevant (+/- 5%) in the last 3 months Metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose). Good physical and psychological state. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomised, double blind crossover intervention
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zein nanocapsules<br>Subjects will consume daily a powder dissolved in water with nanoencapsulated zein | Dietary Supplement: Zein nanocapsules<br>* 1 g of Zein nanoencapsulated daily<br>|
| Placebo Comparator: control<br>Subjects will consume daily a powder dissolved in water with zein | Dietary Supplement: control<br>* 1 g of Zein non-encapsulated daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fructosamine | Change in the levels of Fructosamine From day 0 to day 28 | 28 days | 
| Change in GLP-1 AUC | Change in AUC of postprandial GLP-1 levels after OGTT | Baseline, 15, 30, 45 and 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma glucose | Change in Fasting Plasma glucose from day 0 to day 28 | 28 days | 
| Continuous glucose levels | Area under the curve of 28 days of plasma glucose levels | 28 days | 
| Insulin Levels | Change in Fasting insulin levels from day 0 to day 28 | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zein, Prediabetes, Glycemia and glucose metabolism, Glucose monitoring