Zein Nanoparticles for Glycemic Control (GLUCOCAPS)

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes; Overweight and Obesity; Adult ALL
• Intervention / Treatment: Dietary supplement: Zein nanocapsules; Dietary supplement: control

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Santiago Navas-Carretero, PhD; Phone Number: 806623 +34948425600; Email: snavas@unav.es

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Centro de Investigacion en Nutricion. Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zein nanocapsules; Subjects will consume daily a powder dissolved in water with nanoencapsulated zein	Dietary supplement: Zein nanocapsules; 1 g of Zein nanoencapsulated daily
Placebo Comparator: control; Subjects will consume daily a powder dissolved in water with zein	Dietary supplement: control; 1 g of Zein non-encapsulated daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	28 days
Insulin Levels	Change in Fasting insulin levels from day 0 to day 28	28 days

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Prediabetes; Glucose monitoring; Zein; Glycemia and glucose metabolism
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Body Weight; Hyperglycemia; Prediabetic State; Glucose Intolerance; Overweight
• Other Study ID Numbers: 2022.152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No