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

Primary Purpose

Cardiovascular Disease, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pistachio
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Disease focused on measuring Cardiovascular Disease, Type II Diabetes, Nutrition, Pistachios, Cardiovascular disease risk factors in adults with Type II diabetes

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State University - General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pistachio Diet

Non-Pistachio

Arm Description

Incorporates 3.0 oz (2 servings) of pistachios into a daily diet

Does not incorporate pistachios into a daily diet

Outcomes

Primary Outcome Measures

Cardiovascular responses to stress
Insulin sensitivity and resistance
Lipids and lipoproteins

Secondary Outcome Measures

Vascular endothelial function
Mood and perceived stress

Full Information

First Posted
August 10, 2009
Last Updated
December 13, 2013
Sponsor
Penn State University
Collaborators
American Pistachio Growers
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1. Study Identification

Unique Protocol Identification Number
NCT00956735
Brief Title
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes
Acronym
Pistachio
Official Title
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
American Pistachio Growers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Type 2 Diabetes
Keywords
Cardiovascular Disease, Type II Diabetes, Nutrition, Pistachios, Cardiovascular disease risk factors in adults with Type II diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pistachio Diet
Arm Type
Experimental
Arm Description
Incorporates 3.0 oz (2 servings) of pistachios into a daily diet
Arm Title
Non-Pistachio
Arm Type
No Intervention
Arm Description
Does not incorporate pistachios into a daily diet
Intervention Type
Other
Intervention Name(s)
Pistachio
Intervention Description
3.0 oz (2 servings) of roasted and salted or unsalted pistachios
Primary Outcome Measure Information:
Title
Cardiovascular responses to stress
Time Frame
End of each diet period
Title
Insulin sensitivity and resistance
Time Frame
End of each diet period
Title
Lipids and lipoproteins
Time Frame
End of each diet period
Secondary Outcome Measure Information:
Title
Vascular endothelial function
Time Frame
End of each diet period
Title
Mood and perceived stress
Time Frame
End of each diet period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila G. West, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University - General Clinical Research Center
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802-6501
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18779280
Citation
Gebauer SK, West SG, Kay CD, Alaupovic P, Bagshaw D, Kris-Etherton PM. Effects of pistachios on cardiovascular disease risk factors and potential mechanisms of action: a dose-response study. Am J Clin Nutr. 2008 Sep;88(3):651-9. doi: 10.1093/ajcn/88.3.651.
Results Reference
background
PubMed Identifier
25815738
Citation
Sauder KA, Pokorney PE, McCrea CE, Ulbrecht JS, Kris-Etherton PM, West SG. Noninvasive assessment of hemodynamics: a comparative analysis of fingertip pulse contour analysis and impedance cardiography. Blood Press Monit. 2015 Aug;20(4):209-14. doi: 10.1097/MBP.0000000000000118.
Results Reference
derived
PubMed Identifier
24980134
Citation
Sauder KA, McCrea CE, Ulbrecht JS, Kris-Etherton PM, West SG. Pistachio nut consumption modifies systemic hemodynamics, increases heart rate variability, and reduces ambulatory blood pressure in well-controlled type 2 diabetes: a randomized trial. J Am Heart Assoc. 2014 Jun 30;3(4):e000873. doi: 10.1161/JAHA.114.000873.
Results Reference
derived
Links:
URL
http://bbh.hhdev.psu.edu/lab/WestLab/index.html
Description
Vascular Health Interventions Lab, Penn State University

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

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