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
  Purpose

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 Intervention
Cardiovascular Disease
Type 2 Diabetes
Other: Pistachio

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: August 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00956735

Locations
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
Investigators
Principal Investigator: Sheila G. West, PhD Penn State University
  More Information

Additional Information:
Publications:
Responsible Party: Sheila G West, Associate Professor, Penn State University
ClinicalTrials.gov Identifier: NCT00956735     History of Changes
Other Study ID Numbers: 29970
Study First Received: August 10, 2009
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Cardiovascular Disease
Type II Diabetes
Nutrition
Pistachios
Cardiovascular disease risk factors in adults with Type II diabetes

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

ClinicalTrials.gov processed this record on July 26, 2014