Type 2 DiabetesPhase 2NCT04056208
Pistachios Blood Sugar Control, Heart and Gut Health
A Phase 2 study testing Pistachio in people with Type 2 Diabetes and Cardiovascular Diseases, run by Penn State University at 1 site in United States.
Trial summary
A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Diseases
- What is being tested?
- Pistachio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 17 Nov 2022
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥25 and ≤45 kg/m2
- Fasting plasma glucose 100 - 125 mg/dL
- non-Smoking
Who cannot join
- Diagnosed diabetes or fasting glucose >126 mg/dl
- Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
- Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
- Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
- Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
- Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
Show all 11Show fewer
- Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
- Smoking or use of any tobacco products
- Allergy/intolerance/sensitive to pistachios
- Consumption of >14 alcoholic drinks/week
- Shift-workers and those who cannot consume a snack in the evening
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study
A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.
Read the detailed description
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.
- Conditions
- Type 2 Diabetes, Cardiovascular Diseases
- Being tested
- Pistachio, Usual care
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PistachioDrug
Unsalted pistachios
Usual careOther
Advice and resources will be provided
| Study group | Role | What they receive |
|---|---|---|
| Evening Pistachio Consumption | Active comparator | Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep). Receives: Drug: Pistachio |
| Usual care | Active comparator | Advice to consume a snack that contains 1-2 exchanges (15-30 g of carbohydrate) as an evening snack - this is consistent with the current standard of care for people with impaired fasting glucose. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose concentration
Fasting blood glucose (mg/dL)
Measured: 12 weeks
Secondary outcomes (15)
HbA1c
HbA1c (%) will be assessed at the beginning and end of each treatment period
Measured: 12 weeks
Serum insulin concentration (mIU/L)
fasting serum insulin levels assessed by blood draw
Measured: 12 weeks
Peripheral systolic and diastolic blood pressure (mm Hg)
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).
Measured: 12 weeks
Central systolic and diastolic blood pressure (mm Hg)
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).
Measured: 12 weeks
Carotid-femoral pulse wave velocity (m/s)
A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.
Measured: 12 weeks
Augmentation Index (%)
A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.
Measured: 12 weeks
LDL cholesterol concentration (mg/dL)
Assessed using fasting blood draw
Measured: 12 weeks
HDL cholesterol concentration
Assessed using fasting blood draw
Measured: 12 weeks
Total cholesterol concentration
Assessed using fasting blood draw
Measured: 12 weeks
Triglyceride concentration
Assessed using fasting blood draw
Measured: 12 weeks
HOMA-IR
Assessed using fasting blood draw and standardized HOMA-IR calculation. Fasting plasma glucose multiplied by fasting plasma insulin divided by 405.
Measured: 12 weeks
waist circumference (cm)
Measured 10 cm above the navel
Measured: 12 weeks
body weight (lbs)
Assessed using calibrated scale in Clinical Research Center
Measured: 12 weeks
Diet quality: Healthy Eating Index 2015
Assessed using the Healthy Eating Index 2015
Measured: 12 weeks
Change in the composition of the gut microbiome
microbiome composition assessed using fecal collection kit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start9 Sep 2019
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056208
- Sponsor's protocol ID
- PKE Pistachio
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2019
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riley TM, Wright J, Lamendella R, Bisanz JE, Chen See J, Kanani K, Kris-Etherton PM, Petersen KS. Nighttime Pistachio Consumption Alters Stool Microbiota Diversity and Taxa Abundance Compared with Education to Consume 1-2 Carbohydrate Exchanges (15-30 grams) over 12 Weeks in Adults with Prediabetes: A Secondary Analysis from a Randomized Crossover Trial. Curr Dev Nutr. 2025 May 27;9(7):107481. doi: 10.1016/j.cdnut.2025.107481. eCollection 2025 Jul.
PubMed 40612050Riley TM, Kris-Etherton PM, Hart TL, Petersen KS. Intake of Pistachios as a Nighttime Snack Has Similar Effects on Short- and Longer-Term Glycemic Control Compared with Education to Consume 1-2 Carbohydrate Exchanges in Adults with Prediabetes: A 12-Wk Randomized Crossover Trial. J Nutr. 2024 Apr;154(4):1219-1231. doi: 10.1016/j.tjnut.2024.01.021. Epub 2024 Jan 24.
PubMed 38278217
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study
- ClinicalTrials.gov ID
- NCT04056208
- Acronym / sponsor ID
- PKE Pistachio
- Conditions
- Type 2 Diabetes, Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 14 Aug 2019 (actual)
- 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.
A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.
Detailed description
A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover assignment
| Arm | Type | Receives |
|---|---|---|
| Evening Pistachio Consumption | Active comparator | Drug: PistachioParticipants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep). |
| Usual care | Active comparator | Other: Usual careAdvice to consume a snack that contains 1-2 exchanges (15-30 g of carbohydrate) as an evening snack - this is consistent with the current standard of care for people with impaired fasting glucose. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥25 and ≤45 kg/m2
- Fasting plasma glucose 100 - 125 mg/dL
- non-Smoking
Key exclusion criteria (11 listed)
- Diagnosed diabetes or fasting glucose >126 mg/dl
- Systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
- Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
- Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
- Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
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 |
|---|---|---|
| PistachioUnsalted pistachios | Drug | Evening Pistachio Consumption |
| Usual careAdvice and resources will be provided | Other | Usual care |
Primary outcome
Fasting plasma glucose concentration
Time frame: 12 weeks
Fasting blood glucose (mg/dL)
15 secondary outcomes
HbA1c
Time frame: 12 weeks
Serum insulin concentration (mIU/L)
Time frame: 12 weeks
Peripheral systolic and diastolic blood pressure (mm Hg)
Time frame: 12 weeks
Central systolic and diastolic blood pressure (mm Hg)
Time frame: 12 weeks
Carotid-femoral pulse wave velocity (m/s)
Time frame: 12 weeks
Augmentation Index (%)
Time frame: 12 weeks
LDL cholesterol concentration (mg/dL)
Time frame: 12 weeks
HDL cholesterol concentration
Time frame: 12 weeks
Total cholesterol concentration
Time frame: 12 weeks
Triglyceride concentration
Time frame: 12 weeks
HOMA-IR
Time frame: 12 weeks
waist circumference (cm)
Time frame: 12 weeks
body weight (lbs)
Time frame: 12 weeks
Diet quality: Healthy Eating Index 2015
Time frame: 12 weeks
Change in the composition of the gut microbiome
Time frame: 12 weeks
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 18 Aug 2023.
- Derived from this study: PubMed 40612050Riley TM, Wright J, Lamendella R, Bisanz JE, Chen See J, Kanani K, Kris-Etherton PM, Petersen KS. Nighttime Pistachio Consumption Alters Stool Microbiota Diversity and Taxa Abundance Compared with Education to Consume 1-2 Carbohydrate Exchanges (15-30 grams) over 12 Weeks in Adults with Prediabetes: A Secondary Analysis from a Randomized Crossover Trial. Curr Dev Nutr. 2025 May 27;9(7):107481. doi: 10.1016/j.cdnut.2025.107481. eCollection 2025 Jul.
- Derived from this study: PubMed 38278217Riley TM, Kris-Etherton PM, Hart TL, Petersen KS. Intake of Pistachios as a Nighttime Snack Has Similar Effects on Short- and Longer-Term Glycemic Control Compared with Education to Consume 1-2 Carbohydrate Exchanges in Adults with Prediabetes: A 12-Wk Randomized Crossover Trial. J Nutr. 2024 Apr;154(4):1219-1231. doi: 10.1016/j.tjnut.2024.01.021. Epub 2024 Jan 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pistachio in people with Type 2 Diabetes and Cardiovascular Diseases, 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 3 inclusion and 11 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 18 Aug 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fasting plasma glucose concentration (time frame: 12 weeks). 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 NCT04056208, which also lists 2 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 18 Aug 2023.