Clinical trial · Interventional
Zein Nanoparticles for Glycemic Control
NCT05560412CI-TRIAL-00073470GLUCOCAPScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult ALL | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Overweight and Obesity | — | UNRESOLVED | — |
| PreDiabetes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| control | Dietary Supplement | — | UNRESOLVED |
| Zein nanocapsules | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zein nanocapsules
- description
- Subjects will consume daily a powder dissolved in water with nanoencapsulated zein
- interventionNames
- Dietary Supplement: Zein nanocapsules
- type
- PLACEBO_COMPARATOR
- label
- control
- description
- Subjects will consume daily a powder dissolved in water with zein
- interventionNames
- Dietary Supplement: control
Primary outcomes (2)
- measure
- Change in Fructosamine
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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: \-
References
Publications (0)
Data not yet available
No reference posted for this study.