Peanuts and Glycemic Control

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 2

Conditions: Type2 Diabetes; Cardiovascular Diseases

Treatments: Drug: High carbohydrate snack; Drug: Peanut

Study type: Interventional

Funder types: Other

Identifiers

NCT03654651

use PKE_PEANUT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-smoking
• Impaired fasting glucose at screening (≥ 100 mg/dL).
• BMI ≥20 and ≤40 kg/m2.

Exclusion criteria

• 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
• Pregnancy or lactation
• 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 to test foods
• Consumption of >14 alcoholic drinks/week

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Evening Peanut Consumption

Experimental group

Description:

Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).

Treatment:

Drug: Peanut

Evening Snack

Active Comparator group

Description:

Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).

Treatment:

Drug: High carbohydrate snack