University of Navarra Clinic, University of Navarra
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.
PreDiabetes
Overweight and Obesity
Adult ALL
Zein nanocapsules
control
Not Applicable
| Study Type : | Interventional |
| Estimated Enrollment : | 69 participants |
| Masking : | Quadruple |
| 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. |
| Primary Purpose : | Prevention |
| Official Title : | Zein Nanoparticles for Glycemic Control |
| Actual Study Start Date : | January 10, 2023 |
| Estimated Primary Completion Date : | December 19, 2023 |
| Estimated Study Completion Date : | December 19, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Zein nanocapsules Subjects will consume daily a powder dissolved in water with nanoencapsulated zein |
Dietary Supplement: Zein nanocapsules |
|
Placebo Comparator: control Subjects will consume daily a powder dissolved in water with zein |
Dietary Supplement: control |
| Ages Eligible for Study: | 18 Years to 70 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Nutrition Research Center. university of Navarra
Pamplona, Navarra, Spain, 31008