Peanuts and Glycemic Control

Phase 2

Completed

Conditions: Type2 Diabetes
Cardiovascular Diseases

Interventions: Drug: High carbohydrate snack
Drug: Peanut

Registration Number: NCT03654651

Lead Sponsor: Penn State University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Evening Snack	High carbohydrate snack	Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).
Evening Peanut Consumption	Peanut	Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose	6 weeks	Within-condition mean differences (change from baseline).

Secondary Outcome Measures

Name	Time	Method
Fasting Insulin	6 weeks	Within-condition mean differences (change from baseline).
HDL Cholesterol	6 weeks	Within-condition mean differences (change from baseline).
Fructosamine	6 weeks	Within-condition mean differences (change from baseline).
Central Systolic and Diastolic Blood Pressure	6 weeks	Within-condition mean differences (change from baseline).
Triglycerides	6 weeks	Within-condition mean differences (change from baseline).
Augmentation Index (%)	6 weeks	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).
Microbiota Alpha-diversity	6 weeks	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
Peripheral Systolic and Diastolic Blood Pressure	6 weeks	Within-condition mean differences (change from baseline).
Carotid Femoral Pulse Wave Velocity	6 weeks	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).
LDL Cholesterol	6 weeks	Within-condition mean differences (change from baseline).
Total Cholesterol	6 weeks	Within-condition mean differences (change from baseline).
Body Weight	6 weeks	Within-condition mean differences (change from baseline).