Clinical trial NCT00956735: Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Type 2 Diabetes
Keywords: Cardiovascular Disease
Type II Diabetes
Nutrition
Pistachios
Cardiovascular disease risk factors in adults with Type II diabetes
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: American Pistachio Growers
First posted: 2009-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Cardiovascular responses to stress
timeFrame: End of each diet period
measure: Insulin sensitivity and resistance
timeFrame: End of each diet period
measure: Lipids and lipoproteins
timeFrame: End of each diet period
Secondary outcomes:
measure: Vascular endothelial function
timeFrame: End of each diet period
measure: Mood and perceived stress
timeFrame: End of each diet period
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University - General Clinical Research Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Sheila G. West, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.