Zein Nanoparticles for Glycemic Control (GLUCOCAPS)

University of Navarra

Status: Completed

Conditions: Adult ALL; Overweight and Obesity; PreDiabetes

Treatments: Dietary Supplement: control; Dietary Supplement: Zein nanocapsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05560412

2022.152

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

Zein nanocapsules

Experimental group

Description:

Subjects will consume daily a powder dissolved in water with nanoencapsulated zein

Treatment:

Dietary Supplement: Zein nanocapsules

control

Placebo Comparator group

Description:

Subjects will consume daily a powder dissolved in water with zein

Treatment:

Dietary Supplement: control