NCT04056208

Pistachios Blood Sugar Control, Heart and Gut Health

The Effect of Pistachios on Risk Factors for Cardiometabolic Disease in Individuals With Pre-diabetes: a Randomized, Cross-over Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Type 2 Diabetes
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Pistachio	Unsalted pistachios
OTHER	Usual care	Advice and resources will be provided

Timeline

• Start date: 2019-09-09
• Primary completion: 2022-11-17
• Completion: 2022-11-17
• First posted: 2019-08-14
• Last updated: 2023-08-18

Locations

1 site across 1 country: United States