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

Type 2 Diabetes Clinical Trial

— Pistachio  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956735
• Other study ID #: 29970
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: December 13, 2013
• Start date: August 2009
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Pistachio
3.0 oz (2 servings) of roasted and salted or unsalted pistachios

Locations

Country	Name	City	State
United States	Penn State University - General Clinical Research Center	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	American Pistachio Growers

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular responses to stress		End of each diet period	No
Primary	Insulin sensitivity and resistance		End of each diet period	No
Primary	Lipids and lipoproteins		End of each diet period	No
Secondary	Vascular endothelial function		End of each diet period	No
Secondary	Mood and perceived stress		End of each diet period	No

External Links

•   Vascular Health Interventions Lab, Penn State University