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

This study has been completed.
Sponsor:
Collaborator:
American Pistachio Growers
Information provided by (Responsible Party):
Sheila G West, Penn State University
ClinicalTrials.gov Identifier:
NCT00956735
First received: August 10, 2009
Last updated: December 13, 2013
Last verified: December 2013

August 10, 2009
December 13, 2013
August 2009
March 2013   (final data collection date for primary outcome measure)
  • Cardiovascular responses to stress [ Time Frame: End of each diet period ] [ Designated as safety issue: No ]
  • Insulin sensitivity and resistance [ Time Frame: End of each diet period ] [ Designated as safety issue: No ]
  • Lipids and lipoproteins [ Time Frame: End of each diet period ] [ Designated as safety issue: No ]
Cardiovascular responses to stress [ Time Frame: 10-14 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956735 on ClinicalTrials.gov Archive Site
  • Vascular endothelial function [ Time Frame: End of each diet period ] [ Designated as safety issue: No ]
  • Mood and perceived stress [ Time Frame: End of each diet period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
  • Cardiovascular Disease
  • Type 2 Diabetes
Other: Pistachio
3.0 oz (2 servings) of roasted and salted or unsalted pistachios
  • Experimental: Pistachio Diet
    Incorporates 3.0 oz (2 servings) of pistachios into a daily diet
    Intervention: Other: Pistachio
  • No Intervention: Non-Pistachio
    Does not incorporate pistachios into a daily diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00956735
29970
No
Sheila G West, Penn State University
Penn State University
American Pistachio Growers
Principal Investigator: Sheila G. West, PhD Penn State University
Penn State University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP