Skip to main content
OpenTrials
Completed

NCT Number: NCT01441921

Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus

Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated abnormalities.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University

Reus, Tarragona, 43201, Spain

About this study

In free-living overweight or obese adult with impaired fasting glucose or impaired glucose tolerance we will compare the effects of a pistachio-rich diet or a Mediterranean Diet on:

  • Fasting glucose levels, hemoglobin A1c, insulin, C peptide, HOMA IR, advanced glycation end products and soluble receptor of advanced glycation-end products.
  • Peripheral haemostatic parameters.
  • Plasma inflammatory markers.
  • Lymphocyte expression of toll-like receptors, C peptide, resistin and interleukin-6 in peripheral leukocytes.
  • Lymphocyte glucose transport and expression of glucose transporter 4 in peripheral blood leukocytes.
  • Platelet function including platelet number, mean platelet volume, platelet factor 4 levels and urinary 11-dehydro-thromboxane B2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI less than 35 kg/m2.
  • Fasting plasma glucose levels between 100 and 125 mg/dl or
  • Oral glucose tolerance test of 140 to 199 mg/dl.

Exclusion criteria

  • Diabetes mellitus.
  • Alcohol, tobacco, or drug abuse.
  • Significant liver, kidney, thyroid, or other endocrine diseases.
  • Frequent consumption of nuts or known history of allergy to them.
  • Use of plant sterol, oral antidiabetic drugs, supplemental use of phyllium, fish oil supplements and multivitamins, vitamin E or other antioxidant supplements.
  • Bad dentures, implying difficulty to chew pistachios.
  • Being pregnant or wishing to become a pregnant 6 months before or during the study, lactating 6wk before or during the study.
  • Following vegetarian or weight loss diets.
  • Other medical or social conditions that difficult the compliance to the intervention.

Treatment and study plan

Pistachios

Dietary Supplement

Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.

Total duration of intervention and follow-up is nine months.

Control diet

Other

Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.

Total duration of intervention and follow-up is nine months.

Primary outcomes

  1. Changes from baseline in circulating levels of glucose and insulin according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    Measurement of circulating glucose and insulin levels and cellular glucose uptake

Secondary outcomes

  1. Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    Cpeptide, resistin, IL-6, IL-18, Ghrelin, leptin, adiponectin, GLP-1 and oxidized LDL will be measured.

  2. Changes from baseline in haemostatic parameters according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    Tissue factor, fibrinogen, PAI-1, vWF will be measured.

  3. Changes from baseline in HL and LDL size according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis

  4. Changes in advanced glycation end products according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    Advanced glycation end products and soluble receptor of advanced glycation-end produtcs will be measured

  5. Changes from baseline in gene expression in the peripheral cells according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    RNA from peripheral leukocytes will be isolated for the subsequent measurements of changes in gene expression of toll-like receptors, GLUT-4, C-peptide, resistin adn IL-6, and genes involved in telomere maintenance and oxidation

  6. Changes from baseline in cellular glucose uptake according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes

  7. Changes from baseline in platelet function according to the intervention arm

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm

    Platelet number, mean platelet volume and platelet factor 4 in blood, and urinary levels of 11-dehydro-thromboxane B2 will be assessed.

  8. Changes from baseline in telomeric length of leukocytes (LTL)

    Time frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first intervention arm. Measurements will be not analysed after the second period due to expected carry-over effect.

    Telomere lenght will be evaluated as a biomarker of biological age and general health status. Telomere attrition may play an important role in the pathogenesis and severity of type 2 diabetes (T2D) increasing the probability of beta-cell senescence, leading to reduced cell mass and decreased insulin secretion.

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Collaborators

  • Western Pistachio Association

Registry information

Acronym: EPIRDEM

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Sep 28, 2011
Registry last updated
Feb 11, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.