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OpenTrials
Completed

NCT Number: NCT05560412

Zein Nanoparticles for Glycemic Control

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.

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Key information

Conditions

PreDiabetes Adult ALL Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Prediabetic State Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigacion en Nutricion. Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Zein nanocapsules

Dietary Supplement

1 g of Zein nanoencapsulated daily

Control

Dietary Supplement

1 g of Zein non-encapsulated daily

Primary outcomes

  1. Change in Fructosamine

    Time frame: 28 days

    Change in the levels of Fructosamine From day 0 to day 28

  2. Change in GLP-1 AUC

    Time frame: Baseline, 15, 30, 45 and 60 minutes

    Change in AUC of postprandial GLP-1 levels after OGTT

Secondary outcomes

  1. Fasting Plasma glucose

    Time frame: 28 days

    Change in Fasting Plasma glucose from day 0 to day 28

  2. Continuous glucose levels

    Time frame: 28 days

    Area under the curve of 28 days of plasma glucose levels

  3. Insulin Levels

    Time frame: 28 days

    Change in Fasting insulin levels from day 0 to day 28

Other outcomes

  1. Cholesterol

    Time frame: 28 days

    Change in Total cholesterol from day 0 to day 28

  2. HDL-Cholesterol

    Time frame: 28 days

    Change in HDL-cholesterol from day 0 to day 28

  3. LDL-Cholesterol

    Time frame: 28 days

    Change in LDL-cholesterol from day 0 to day 28

  4. Triglycerides

    Time frame: 28 days

    Change in Triglycerides from day 0 to day 28

  5. Blood Pressure

    Time frame: 28 days

    Changes in DBP and SBP from beginning to end of intervention

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Acronym: GLUCOCAPS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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