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| Name | Class |
|---|---|
| Western Pistachio Association | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control diet | Active Comparator | Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins) |
|
| Pistachio diet | Experimental | Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica Bullo, Dra. | Institut Investigacio Sanitaria Pere Virgili | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University | Reus | Tarragona | 43201 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25791863 | Background | Hernandez-Alonso P, Salas-Salvado J, Baldrich-Mora M, Mallol R, Correig X, Bullo M. Effect of pistachio consumption on plasma lipoprotein subclasses in pre-diabetic subjects. Nutr Metab Cardiovasc Dis. 2015 Apr;25(4):396-402. doi: 10.1016/j.numecd.2015.01.013. Epub 2015 Feb 7. | |
| 25125505 | Result | Hernandez-Alonso P, Salas-Salvado J, Baldrich-Mora M, Juanola-Falgarona M, Bullo M. Beneficial effect of pistachio consumption on glucose metabolism, insulin resistance, inflammation, and related metabolic risk markers: a randomized clinical trial. Diabetes Care. 2014 Nov;37(11):3098-105. doi: 10.2337/dc14-1431. Epub 2014 Aug 14. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| Changes from baseline in haemostatic parameters according to the intervention arm | Tissue factor, fibrinogen, PAI-1, vWF will be measured. | 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 | 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 | 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 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 | 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 | 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. | 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. | 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. |
| 28432876 | Result | Hernandez-Alonso P, Canueto D, Giardina S, Salas-Salvado J, Canellas N, Correig X, Bullo M. Effect of pistachio consumption on the modulation of urinary gut microbiota-related metabolites in prediabetic subjects. J Nutr Biochem. 2017 Jul;45:48-53. doi: 10.1016/j.jnutbio.2017.04.002. Epub 2017 Apr 12. |
| 27383196 | Result | Hernandez-Alonso P, Giardina S, Salas-Salvado J, Arcelin P, Bullo M. Chronic pistachio intake modulates circulating microRNAs related to glucose metabolism and insulin resistance in prediabetic subjects. Eur J Nutr. 2017 Sep;56(6):2181-2191. doi: 10.1007/s00394-016-1262-5. Epub 2016 Jul 6. |
| 31051499 | Derived | Canudas S, Hernandez-Alonso P, Galie S, Muralidharan J, Morell-Azanza L, Zalba G, Garcia-Gavilan J, Marti A, Salas-Salvado J, Bullo M. Pistachio consumption modulates DNA oxidation and genes related to telomere maintenance: a crossover randomized clinical trial. Am J Clin Nutr. 2019 Jun 1;109(6):1738-1745. doi: 10.1093/ajcn/nqz048. |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |