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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
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.
Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University
Reus, Tarragona, Spain
Changes from baseline in circulating levels of glucose and insulin according to the intervention arm
Measurement of circulating glucose and insulin levels and cellular glucose uptake
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
Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm
Cpeptide, resistin, IL-6, IL-18, Ghrelin, leptin, adiponectin, GLP-1 and oxidized LDL will be measured.
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
Changes from baseline in haemostatic parameters according to the intervention arm
Tissue factor, fibrinogen, PAI-1, vWF will be measured.
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
Changes from baseline in HL and LDL size according to the intervention arm
Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis
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
Changes in advanced glycation end products according to the intervention arm
Advanced glycation end products and soluble receptor of advanced glycation-end produtcs will be measured
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes from baseline in gene expression in the peripheral cells according to the 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
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
Changes from baseline in cellular glucose uptake according to the intervention arm
Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes
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
Changes from baseline in platelet function according to the intervention arm
Platelet number, mean platelet volume and platelet factor 4 in blood, and urinary levels of 11-dehydro-thromboxane B2 will be assessed.
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
Changes from baseline in telomeric length of leukocytes (LTL)
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.
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.