Pennsylvania State University
University Park, Pennsylvania, 16802, United States
NCT Number: NCT04056208
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.
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Notify Me30 year–65 year
All sexes
Interventional
Phase 2
University Park, Pennsylvania, 16802, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unsalted pistachios
Advice and resources will be provided
Time frame: 12 weeks
Fasting blood glucose (mg/dL)
Time frame: 12 weeks
HbA1c (%) will be assessed at the beginning and end of each treatment period
Time frame: 12 weeks
fasting serum insulin levels assessed by blood draw
Time frame: 12 weeks
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).
Time frame: 12 weeks
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical).
Time frame: 12 weeks
A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.
Time frame: 12 weeks
A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness.
Time frame: 12 weeks
Assessed using fasting blood draw
Time frame: 12 weeks
Assessed using fasting blood draw
Time frame: 12 weeks
Assessed using fasting blood draw
Time frame: 12 weeks
Assessed using fasting blood draw
Time frame: 12 weeks
Assessed using fasting blood draw and standardized HOMA-IR calculation. Fasting plasma glucose multiplied by fasting plasma insulin divided by 405.
Time frame: 12 weeks
Measured 10 cm above the navel
Time frame: 12 weeks
Assessed using calibrated scale in Clinical Research Center
Time frame: 12 weeks
Assessed using the Healthy Eating Index 2015
Time frame: 12 weeks
microbiome composition assessed using fecal collection kit
Penn State University
Other
The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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