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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pistachios
control diet
Sponsored by
Institut Investigacio Sanitaria Pere Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring pistachio intake, insulin resistance, type 2 diabetes mellitus

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control diet

Pistachio diet

Arm Description

Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)

Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Changes from baseline in haemostatic parameters according to the intervention arm
Tissue factor, fibrinogen, PAI-1, vWF will be measured.
Changes from baseline in HL and LDL size according to the intervention arm
Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis
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
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
Changes from baseline in cellular glucose uptake according to the intervention arm
Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes
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.
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.

Full Information

First Posted
September 20, 2011
Last Updated
February 7, 2019
Sponsor
Institut Investigacio Sanitaria Pere Virgili
Collaborators
Western Pistachio Association
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1. Study Identification

Unique Protocol Identification Number
NCT01441921
Brief Title
Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
Acronym
EPIRDEM
Official Title
Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Investigacio Sanitaria Pere Virgili
Collaborators
Western Pistachio Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
pistachio intake, insulin resistance, type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control diet
Arm Type
Active Comparator
Arm Description
Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)
Arm Title
Pistachio diet
Arm Type
Experimental
Arm Description
Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)
Intervention Type
Dietary Supplement
Intervention Name(s)
Pistachios
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control diet
Intervention Description
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 Outcome Measure Information:
Title
Changes from baseline in circulating levels of glucose and insulin according to the intervention arm
Description
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
Secondary Outcome Measure Information:
Title
Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm
Description
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
Title
Changes from baseline in haemostatic parameters according to the intervention arm
Description
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
Title
Changes from baseline in HL and LDL size according to the intervention arm
Description
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
Title
Changes in advanced glycation end products according to the intervention arm
Description
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
Title
Changes from baseline in gene expression in the peripheral cells according to the intervention arm
Description
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
Title
Changes from baseline in cellular glucose uptake according to the intervention arm
Description
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
Title
Changes from baseline in platelet function according to the intervention arm
Description
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
Title
Changes from baseline in telomeric length of leukocytes (LTL)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Bullo, Dra.
Organizational Affiliation
Institut Investigacio Sanitaria Pere Virgili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43201
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25791863
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.
Results Reference
background
PubMed Identifier
25125505
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.
Results Reference
result
PubMed Identifier
28432876
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.
Results Reference
result
PubMed Identifier
27383196
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.
Results Reference
result
PubMed Identifier
31051499
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.
Results Reference
derived
Links:
URL
http://www.iispv.cat/
Description
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Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus

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