Adult ALL, Overweight and Obesity, PreDiabetes
Conditions
Keywords
Prediabetes, Glycemia and glucose metabolism, Zein, Glucose monitoring
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.
Interventions
DIETARY_SUPPLEMENTZein nanocapsules
1 g of Zein nanoencapsulated daily
DIETARY_SUPPLEMENTcontrol
1 g of Zein non-encapsulated daily
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The products (experimental and Placebo), will be produced by an external producer, who will retain the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study.
Intervention model description
Randomised, double blind crossover intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fructosamine | 28 days | Change in the levels of Fructosamine From day 0 to day 28 |
| Change in GLP-1 AUC | Baseline, 15, 30, 45 and 60 minutes | Change in AUC of postprandial GLP-1 levels after OGTT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plasma glucose | 28 days | Change in Fasting Plasma glucose from day 0 to day 28 |
| Continuous glucose levels | 28 days | Area under the curve of 28 days of plasma glucose levels |
| Insulin Levels | 28 days | Change in Fasting insulin levels from day 0 to day 28 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 28 days | Changes in DBP and SBP from beginning to end of intervention |
| HDL-Cholesterol | 28 days | Change in HDL-cholesterol from day 0 to day 28 |
| Cholesterol | 28 days | Change in Total cholesterol from day 0 to day 28 |
| LDL-Cholesterol | 28 days | Change in LDL-cholesterol from day 0 to day 28 |
| Triglycerides | 28 days | Change in Triglycerides from day 0 to day 28 |
Countries
Spain
Outcome results
None listed