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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Institut Investigacio Sanitaria Pere Virgili.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Western Pistachio Association
Information provided by (Responsible Party):
Dra Monica Bullo, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier:
NCT01441921
First received: September 20, 2011
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Dietary Supplement: Pistachios
Other: control diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Institut Investigacio Sanitaria Pere Virgili:

Primary Outcome Measures:
  • Changes from baseline in circulating levels of glucose and insulin according to the intervention arm [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    Tissue factor, fibrinogen, PAI-1, vWF will be measured.

  • Changes from baseline in HL and LDL size according to the intervention arm [ 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 ] [ Designated as safety issue: No ]
    Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis

  • Changes in advanced glycation end products according to the intervention arm [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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

  • Changes from baseline in cellular glucose uptake according to the intervention arm [ 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 ] [ Designated as safety issue: No ]
    Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes

  • Changes from baseline in platelet function according to the intervention arm [ 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 ] [ Designated as safety issue: No ]
    Platelet number, mean platelet volume and platelet factor 4 in blood, and urinary levels of 11-dehydro-thromboxane B2 will be assessed.


Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control diet
Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)
Other: 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.

Experimental: Pistachio diet
Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)
Dietary Supplement: 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.


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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441921

Contacts
Contact: Monica Bullo, Dra. 977759312 monica.bullo@urv.cat

Locations
Spain
Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University Recruiting
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
Western Pistachio Association
Investigators
Principal Investigator: Monica Bullo, Dra. Institut Investigacio Sanitaria Pere Virgili
  More Information

Additional Information:
No publications provided

Responsible Party: Dra Monica Bullo, Principal Investigators, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier: NCT01441921     History of Changes
Other Study ID Numbers: PV11059S
Study First Received: September 20, 2011
Last Updated: September 26, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Institut Investigacio Sanitaria Pere Virgili:
pistachio intake
insulin resistance
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014