Zein Nanoparticles for Glycemic Control

Overweight and Obesity Clinical Trial

— GLUCOCAPS  

Official title:

Zein Nanoparticles for Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560412
• Other study ID #: 2022.152
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: November 2023
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Adult ALL
• Glucose Intolerance
• Overweight
• Overweight and Obesity
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Zein nanocapsules
1 g of Zein nanoencapsulated daily
• control
1 g of Zein non-encapsulated daily

Locations

Country	Name	City	State
Spain	Centro de Investigacion en Nutricion. Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cholesterol	Change in Total cholesterol from day 0 to day 28	28 days
Other	HDL-Cholesterol	Change in HDL-cholesterol from day 0 to day 28	28 days
Other	LDL-Cholesterol	Change in LDL-cholesterol from day 0 to day 28	28 days
Other	Triglycerides	Change in Triglycerides from day 0 to day 28	28 days
Other	Blood Pressure	Changes in DBP and SBP from beginning to end of intervention	28 days
Primary	Change in Fructosamine	Change in the levels of Fructosamine From day 0 to day 28	28 days
Primary	Change in GLP-1 AUC	Change in AUC of postprandial GLP-1 levels after OGTT	Baseline, 15, 30, 45 and 60 minutes
Secondary	Fasting Plasma glucose	Change in Fasting Plasma glucose from day 0 to day 28	28 days
Secondary	Continuous glucose levels	Area under the curve of 28 days of plasma glucose levels	28 days
Secondary	Insulin Levels	Change in Fasting insulin levels from day 0 to day 28	28 days