Zein Nanoparticles for Glycemic Control (GLUCOCAPS)
Primary Purpose
PreDiabetes, Overweight and Obesity, Adult ALL
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Zein nanocapsules
control
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes focused on measuring Prediabetes, Glycemia and glucose metabolism, Zein, Glucose monitoring
Eligibility Criteria
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:
-
Sites / Locations
- Centro de Investigacion en Nutricion. Universidad de NavarraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Zein nanocapsules
control
Arm Description
Subjects will consume daily a powder dissolved in water with nanoencapsulated zein
Subjects will consume daily a powder dissolved in water with zein
Outcomes
Primary Outcome Measures
Change in Fructosamine
Change in the levels of Fructosamine From day 0 to day 28
Change in GLP-1 AUC
Change in AUC of postprandial GLP-1 levels after OGTT
Secondary Outcome Measures
Fasting Plasma glucose
Change in Fasting Plasma glucose from day 0 to day 28
Continuous glucose levels
Area under the curve of 28 days of plasma glucose levels
Insulin Levels
Change in Fasting insulin levels from day 0 to day 28
Full Information
NCT ID
NCT05560412
First Posted
September 26, 2022
Last Updated
August 30, 2023
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
1. Study Identification
Unique Protocol Identification Number
NCT05560412
Brief Title
Zein Nanoparticles for Glycemic Control
Acronym
GLUCOCAPS
Official Title
Zein Nanoparticles for Glycemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
December 19, 2023 (Anticipated)
Study Completion Date
December 19, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Overweight and Obesity, Adult ALL
Keywords
Prediabetes, Glycemia and glucose metabolism, Zein, Glucose monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised, double blind crossover intervention
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zein nanocapsules
Arm Type
Experimental
Arm Description
Subjects will consume daily a powder dissolved in water with nanoencapsulated zein
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Subjects will consume daily a powder dissolved in water with zein
Intervention Type
Dietary Supplement
Intervention Name(s)
Zein nanocapsules
Intervention Description
1 g of Zein nanoencapsulated daily
Intervention Type
Dietary Supplement
Intervention Name(s)
control
Intervention Description
1 g of Zein non-encapsulated daily
Primary Outcome Measure Information:
Title
Change in Fructosamine
Description
Change in the levels of Fructosamine From day 0 to day 28
Time Frame
28 days
Title
Change in GLP-1 AUC
Description
Change in AUC of postprandial GLP-1 levels after OGTT
Time Frame
Baseline, 15, 30, 45 and 60 minutes
Secondary Outcome Measure Information:
Title
Fasting Plasma glucose
Description
Change in Fasting Plasma glucose from day 0 to day 28
Time Frame
28 days
Title
Continuous glucose levels
Description
Area under the curve of 28 days of plasma glucose levels
Time Frame
28 days
Title
Insulin Levels
Description
Change in Fasting insulin levels from day 0 to day 28
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Cholesterol
Description
Change in Total cholesterol from day 0 to day 28
Time Frame
28 days
Title
HDL-Cholesterol
Description
Change in HDL-cholesterol from day 0 to day 28
Time Frame
28 days
Title
LDL-Cholesterol
Description
Change in LDL-cholesterol from day 0 to day 28
Time Frame
28 days
Title
Triglycerides
Description
Change in Triglycerides from day 0 to day 28
Time Frame
28 days
Title
Blood Pressure
Description
Changes in DBP and SBP from beginning to end of intervention
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santiago Navas-Carretero, PhD
Phone
+34948425600
Ext
806623
Email
snavas@unav.es
Facility Information:
Facility Name
Centro de Investigacion en Nutricion. Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Goñi, MsC
Phone
+34948425744
Email
voluntariosnut@unav.es
First Name & Middle Initial & Last Name & Degree
Santiago Navas-Carretero, PhD
First Name & Middle Initial & Last Name & Degree
M. Soledad García-Unciti, PhD
First Name & Middle Initial & Last Name & Degree
Carlos J Gonzalez-Navarro, PhD
First Name & Middle Initial & Last Name & Degree
Juan M Irache, PhD
First Name & Middle Initial & Last Name & Degree
Blanca Martinez de Morentin, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Zein Nanoparticles for Glycemic Control
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