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Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes (Pistachio)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00956735
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : December 16, 2013
American Pistachio Growers
Information provided by (Responsible Party):
Sheila G West, Penn State University

Brief Summary:
This study is investigating the effects of three different diets, including a diet with pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Type 2 Diabetes Other: Pistachio Not Applicable

Detailed Description:
The study will last 12-16 weeks and requires 10-13 visits to the General Clinical Research Center on the University Park campus. All food and snacks will be provided for 10 weeks. At the end of each of three diet periods, participants will undergo a test of endothelial function, an oral glucose tolerance test, and a cardiovascular stress reactivity test.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population
Study Start Date : August 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pistachio Diet
Incorporates 3.0 oz (2 servings) of pistachios into a daily diet
Other: Pistachio
3.0 oz (2 servings) of roasted and salted or unsalted pistachios

No Intervention: Non-Pistachio
Does not incorporate pistachios into a daily diet

Primary Outcome Measures :
  1. Cardiovascular responses to stress [ Time Frame: End of each diet period ]
  2. Insulin sensitivity and resistance [ Time Frame: End of each diet period ]
  3. Lipids and lipoproteins [ Time Frame: End of each diet period ]

Secondary Outcome Measures :
  1. Vascular endothelial function [ Time Frame: End of each diet period ]
  2. Mood and perceived stress [ Time Frame: End of each diet period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal)
  • Diagnosed with Type 2 diabetes

Exclusion Criteria:

  • Insulin, more than one blood pressure lowering medication, daily aspirin, NSAID therapy, oral steroids within the last 6 weeks, oral contraceptives, and hormone replacement therapy
  • Chronic disease such as cardiovascular disease or any complications of diabetes (retinopathy, neuropathy, etc).
  • Allergies or aversions to pistachios
  • Unwillingness to consume all foods provided and no other meals or snacks for the 10 weeks of diet intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00956735

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United States, Pennsylvania
Penn State University - General Clinical Research Center
University Park, Pennsylvania, United States, 16802-6501
Sponsors and Collaborators
Penn State University
American Pistachio Growers
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Principal Investigator: Sheila G. West, PhD Penn State University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sheila G West, Associate Professor, Penn State University Identifier: NCT00956735     History of Changes
Other Study ID Numbers: 29970
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013

Keywords provided by Sheila G West, Penn State University:
Cardiovascular Disease
Type II Diabetes
Cardiovascular disease risk factors in adults with Type II diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases