NCT03654651

Peanuts and Glycemic Control

The Role of the Microbiome in Blood Glucose Regulation in Response to Peanut Consumption

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A two-period randomized crossover study will be conducted to determine the effect of peanuts on glycemic control, and elucidate the role of the microbiome in glucose regulation, in individuals with impaired fasting glucose.

Detailed description

A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 6 weeks followed by a minimum 4-week wash-out period. During the peanut treatment, participants will consume one ounce per day (28 g) of peanuts as an evening snack. The control treatments will be an isocaloric higher carbohydrate snack consumed after the evening meal. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.

Conditions

• Type2 Diabetes
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Peanut	Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.
DRUG	High carbohydrate snack	Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2018-08-31
• Last updated: 2023-08-18
• Results posted: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study