Zein Nanoparticles for Glycemic Control

NCT05560412 | Completed

• 1 other identifier: 2022.152
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Overweight and Obesity; Adult ALL

Keywords

Prediabetes; Glycemia and glucose metabolism; Zein; Glucose monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Fasting Plasma glucose

  28 days

• Continuous glucose levels

  28 days

• Insulin Levels

  28 days

Other Outcomes (5)

• Cholesterol

  28 days

• HDL-Cholesterol

  28 days

• LDL-Cholesterol

  28 days

Study Arms (2)

Zein nanocapsules

EXPERIMENTAL

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

Dietary Supplement: Zein nanocapsules

control

PLACEBO COMPARATOR

Subjects will consume daily a powder dissolved in water with zein

Dietary Supplement: control

Interventions

Zein nanocapsules DIETARY_SUPPLEMENT

1 g of Zein nanoencapsulated daily

Zein nanocapsules

control DIETARY_SUPPLEMENT

1 g of Zein non-encapsulated daily

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Centro de Investigacion en Nutricion. Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double blind crossover intervention

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: January 10, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 31, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)