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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zein nanocapsules | Experimental | Subjects will consume daily a powder dissolved in water with nanoencapsulated zein |
|
| control | Placebo Comparator | Subjects will consume daily a powder dissolved in water with zein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zein nanocapsules | Dietary Supplement | 1 g of Zein nanoencapsulated daily |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol | Change in Total cholesterol from day 0 to day 28 | 28 days |
| HDL-Cholesterol | Change in HDL-cholesterol from day 0 to day 28 | 28 days |
Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigacion en Nutricion. Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomised, double blind crossover intervention
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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.
| control |
| Dietary Supplement |
1 g of Zein non-encapsulated daily |
|
| 28 days |
| Insulin Levels | Change in Fasting insulin levels from day 0 to day 28 | 28 days |
| LDL-Cholesterol | Change in LDL-cholesterol from day 0 to day 28 | 28 days |
| Triglycerides | Change in Triglycerides from day 0 to day 28 | 28 days |
| Blood Pressure | Changes in DBP and SBP from beginning to end of intervention | 28 days |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |