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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Cardiovascular Disease
• Interventions: Other: Pistachio

• Registration Number: NCT00956735
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pistachio Diet	Pistachio	Incorporates 3.0 oz (2 servings) of pistachios into a daily diet

Primary Outcome Measures

Name	Time	Method
Cardiovascular responses to stress	End of each diet period
Insulin sensitivity and resistance	End of each diet period
Lipids and lipoproteins	End of each diet period

Secondary Outcome Measures

Name	Time	Method
Vascular endothelial function	End of each diet period
Mood and perceived stress	End of each diet period

Trial Locations

Locations (1)

Penn State University - General Clinical Research Center; 🇺🇸 University Park, Pennsylvania, United States