Cardiovascular DiseasePistachioNCT00956735
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes
A study testing Pistachio in people with Cardiovascular Disease and Type 2 Diabetes, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Type 2 Diabetes
- What is being tested?
- Pistachio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal)
- Diagnosed with Type 2 diabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University - General Clinical Research Center
University Park, Pennsylvania, 16802-6501
About this study
Official title: Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Type 2 Diabetes
- Being tested
- Pistachio
- Keywords
- Cardiovascular Disease, Type II Diabetes, Nutrition, Pistachios, Cardiovascular disease risk factors in adults with Type II diabetes
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PistachioOther
3.0 oz (2 servings) of roasted and salted or unsalted pistachios
| Study group | Role | What they receive |
|---|---|---|
| Pistachio Diet | Experimental | Incorporates 3.0 oz (2 servings) of pistachios into a daily diet Receives: Other: Pistachio |
| Non-Pistachio | No intervention | Does not incorporate pistachios into a daily diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular responses to stress
Measured: End of each diet period
Insulin sensitivity and resistance
Measured: End of each diet period
Lipids and lipoproteins
Measured: End of each diet period
Secondary outcomes (2)
Vascular endothelial function
Measured: End of each diet period
Mood and perceived stress
Measured: End of each diet period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Pistachio Growers
- Responsible party
- Principal investigator, Sheila G West, Penn State University
- Investigators
- Sheila G. West, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956735
- Sponsor's protocol ID
- 29970
- Acronym
- Pistachio
- Status last verified
- Dec 2013
- First submitted
- 10 Aug 2009
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1093/ajcn/88.3.651.
PubMed 18779280Sauder 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.
PubMed 25815738Sauder 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.
PubMed 24980134
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population
- ClinicalTrials.gov ID
- NCT00956735
- Acronym / sponsor ID
- Pistachio / 29970
- Conditions
- Cardiovascular Disease, Type 2 Diabetes
- Keywords
- Cardiovascular Disease, Type II Diabetes, Nutrition, Pistachios, Cardiovascular disease risk factors in adults with Type II diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- American Pistachio Growers
- Study start
- Aug 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pistachio Diet | Experimental | Other: PistachioIncorporates 3.0 oz (2 servings) of pistachios into a daily diet |
| Non-Pistachio | No intervention | –Does not incorporate pistachios into a daily diet |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal)
- Diagnosed with Type 2 diabetes
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pistachio3.0 oz (2 servings) of roasted and salted or unsalted pistachios | Other | Pistachio Diet |
Primary outcome
Cardiovascular responses to stress
Time frame: End of each diet period
Insulin sensitivity and resistance
Time frame: End of each diet period
Lipids and lipoproteins
Time frame: End of each diet period
2 secondary outcomes
Vascular endothelial function
Time frame: End of each diet period
Mood and perceived stress
Time frame: End of each diet period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Background: PubMed 18779280Gebauer 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.
- Derived from this study: PubMed 25815738Sauder 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.
- Derived from this study: PubMed 24980134Sauder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila G. West, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pistachio in people with Cardiovascular Disease and Type 2 Diabetes, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular responses to stress (time frame: End of each diet period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00956735, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.