Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
NCT ID: NCT01441921
Last Updated: 2019-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-09-30
2017-09-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Control diet
Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)
control diet
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.
Pistachio diet
Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)
Pistachios
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.
Interventions
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Pistachios
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
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.
Eligibility Criteria
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Inclusion Criteria
* Fasting plasma glucose levels between 100 and 125 mg/dl or
* Oral glucose tolerance test of 140 to 199 mg/dl.
Exclusion Criteria
* 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.
25 Years
65 Years
ALL
No
Sponsors
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Western Pistachio Association
OTHER
Institut Investigacio Sanitaria Pere Virgili
OTHER
Responsible Party
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Dra Monica Bullo
Principal Investigators
Principal Investigators
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Monica Bullo, Dra.
Role: PRINCIPAL_INVESTIGATOR
Institut Investigacio Sanitaria Pere Virgili
Locations
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Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University
Reus, Tarragona, Spain
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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PV11059S
Identifier Type: -
Identifier Source: org_study_id
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