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Completed

NCT Number: NCT00956735

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University - General Clinical Research Center

University Park, Pennsylvania, 16802-6501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pistachio

Other

3.0 oz (2 servings) of roasted and salted or unsalted pistachios

Primary outcomes

  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 outcomes

  1. Vascular endothelial function

    Time frame: End of each diet period

  2. Mood and perceived stress

    Time frame: End of each diet period

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • American Pistachio Growers

Registry information

Official study title

Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population

Acronym: Pistachio

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2009
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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