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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by Penn State University.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Western Pistachio Association

Information provided by:

Penn State University

ClinicalTrials.gov Identifier:

NCT00956735

First received: August 10, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 10, 2009

Last Updated Date

August 10, 2009

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiovascular responses to stress [ Time Frame: 10-14 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The purpose of this research is to examine the cardiovascular changes in type 2 diabetics caused by eating different diets including pistachios. This study may provide important information about the health effects of pistachios in the diet.

Detailed Description

This study will last approximately 12 weeks and will require you to make ten visits to the Research Clinic on the University Park campus: 1 screening exam, 3 ultrasound visits each lasting one hour, 3 glucose tolerance test visits lasting 2 hours, and 3 stress visits lasting 2.5 hours. It will also require you to eat one meal on campus every day, Monday through Friday. For this study, you will be consuming a run-in diet (western diet) for two weeks then two different diets for 4 week periods at a time. All meals and snacks will be provided to you throughout the course of the study and no foods outside of those provided can be consumed during the diet period. Also, there are limits on both alcohol and caffeine consumption during the study. There is a 2 week break between the diet periods (not between the run-in and first diet period), during which you can eat whatever you would like.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Cardiovascular Disease
Type 2 Diabetes

Intervention ^ICMJE

Other: Pistachio

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

Study Arm (s)

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

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy, nonsmoking adults, aged 30-70 years (women must be post-menopausal)
Diagnosed with Type 2 diabetes at least six months prior

Exclusion Criteria:

Insulin, blood pressure lowering, 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 8 weeks of diet intervention

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kate Sauder, BA

814-863-0926

kaf22@psu.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00956735

Other Study ID Numbers ^ICMJE

29970

Has Data Monitoring Committee

Yes

Responsible Party

Sheila G West, PhD, Director, Vascular Health Interventions Laboratory, Penn State University

Study Sponsor ^ICMJE

Penn State University

Collaborators ^ICMJE

Western Pistachio Association

Investigators ^ICMJE

Not Provided

Information Provided By

Penn State University

Verification Date

August 2009

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

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