MedDataX Logo

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

NCT ID: NCT00956735

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease Type 2 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiovascular Disease Type II Diabetes Nutrition Pistachios Cardiovascular disease risk factors in adults with Type II diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pistachio Diet

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

Group Type EXPERIMENTAL

Pistachio

Intervention Type OTHER

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

Non-Pistachio

Does not incorporate pistachios into a daily diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pistachio

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Pistachio Growers

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sheila G West

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sheila G. West, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Penn State University - General Clinical Research Center

University Park, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18779280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25815738 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24980134 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://bbh.hhdev.psu.edu/lab/WestLab/index.html

Vascular Health Interventions Lab, Penn State University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

29970

Identifier Type: -

Identifier Source: org_study_id