Peanuts and Glycemic Control

Penn State University51 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Type2 Diabetes Cardiovascular Diseases

Interventions

PeanutDRUG

Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.

High carbohydrate snackDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pennsylvania State University

University Park, Pennsylvania, United States

Outcomes

Primary Outcomes

Fasting Plasma Glucose

Within-condition mean differences (change from baseline).

Time frame: 6 weeks

Secondary Outcomes

Fructosamine

Within-condition mean differences (change from baseline).

Time frame: 6 weeks

Fasting Insulin

Within-condition mean differences (change from baseline).

Time frame: 6 weeks

Peripheral Systolic and Diastolic Blood Pressure

Within-condition mean differences (change from baseline).

Time frame: 6 weeks

Central Systolic and Diastolic Blood Pressure

Within-condition mean differences (change from baseline).

Time frame: 6 weeks

Carotid Femoral Pulse Wave Velocity

Carotid-femoral pulse wave velocity is a measure of arterial stiffness and is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. Within-condition mean differences (change from baseline).

Time frame: 6 weeks

Augmentation Index (%)

A measure of arterial stiffness assessed using a SphymoCor Ecel (Atcor Medical). A higher percentage value is indicative of greater arterial stiffness Within-condition mean differences (change from baseline).

Time frame: 6 weeks

LDL Cholesterol

Within-condition mean differences (change from baseline).

Data from ClinicalTrials.gov

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