Peanuts and Glycemic Control

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Type2 Diabetes, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: Peanut
* Drug: High carbohydrate snack


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evening Peanut Consumption<br>Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep). | Drug: Peanut<br>* Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.<br>|
| Active Comparator: Evening Snack<br>Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep). | Drug: High carbohydrate snack<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose | Within-condition mean differences (change from baseline). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructosamine | Within-condition mean differences (change from baseline). | 6 weeks | 
| Fasting Insulin | Within-condition mean differences (change from baseline). | 6 weeks | 
| Peripheral Systolic and Diastolic Blood Pressure | Within-condition mean differences (change from baseline). | 6 weeks | 
| Central Systolic and Diastolic Blood Pressure | Within-condition mean differences (change from baseline). | 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). | 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). | 6 weeks | 
| LDL Cholesterol | Within-condition mean differences (change from baseline). | 6 weeks | 
| HDL Cholesterol | Within-condition mean differences (change from baseline). | 6 weeks | 
| Total Cholesterol | Within-condition mean differences (change from baseline). | 6 weeks | 
| Triglycerides | Within-condition mean differences (change from baseline). | 6 weeks | 
| Body Weight | Within-condition mean differences (change from baseline). | 6 weeks | 
| Microbiota Alpha-diversity | Measured by Faith's Phylogenetic Diversity Score. This is a measure of biodiversity (based on phylogeny). Faith's phylogenetic diversity measures the amount of the phylogenetic tree covered by the bacterial community. It's a sum of the minimum branch lengths. A higher number (more branches), means more richness (more diversity). Increases in Faith's Phylogenetic Diversity is indicative of more richness and diversity but no standard reference range or clinically relevant values have been established. Presented as endpoint mean values with IQR | 6 weeks |