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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pistachio | Drug | Unsalted pistachios |
| |
| Usual care |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose concentration | Fasting blood glucose (mg/dL) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c (%) will be assessed at the beginning and end of each treatment period | 12 weeks |
| Serum insulin concentration (mIU/L) | fasting serum insulin levels assessed by blood draw |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40612050 | Derived | 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. | |
| 38278217 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Crossover assignment
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| Other |
Advice and resources will be provided |
|
| 12 weeks |
| Peripheral systolic and diastolic blood pressure (mm Hg) | Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical). | 12 weeks |
| Central systolic and diastolic blood pressure (mm Hg) | Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical). | 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. | 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. | 12 weeks |
| LDL cholesterol concentration (mg/dL) | Assessed using fasting blood draw | 12 weeks |
| HDL cholesterol concentration | Assessed using fasting blood draw | 12 weeks |
| Total cholesterol concentration | Assessed using fasting blood draw | 12 weeks |
| Triglyceride concentration | Assessed using fasting blood draw | 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. | 12 weeks |
| waist circumference (cm) | Measured 10 cm above the navel | 12 weeks |
| body weight (lbs) | Assessed using calibrated scale in Clinical Research Center | 12 weeks |
| Diet quality: Healthy Eating Index 2015 | Assessed using the Healthy Eating Index 2015 | 12 weeks |
| Change in the composition of the gut microbiome | microbiome composition assessed using fecal collection kit | 12 weeks |
| Derived |
| Riley 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. |
| D004700 | Endocrine System Diseases |