Clinical trial NCT01441921: Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
Official title: Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: pistachio intake
insulin resistance
type 2 diabetes mellitus
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
Collaborators: name: Western Pistachio Association
First posted: 2011-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline in circulating levels of glucose and insulin according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
Secondary outcomes:
measure: Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
measure: Changes from baseline in haemostatic parameters according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
measure: Changes from baseline in HL and LDL size according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
measure: Changes in advanced glycation end products according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
measure: Changes from baseline in gene expression in the peripheral cells according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
measure: Changes from baseline in cellular glucose uptake according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
measure: Changes from baseline in platelet function according to the intervention arm
timeFrame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm
measure: Changes from baseline in telomeric length of leukocytes (LTL)
timeFrame: 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.
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University
state: Tarragona
Study officials:
affiliation: Institut Investigacio Sanitaria Pere Virgili
name: Monica Bullo, Dra.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.