About this trial
The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
men and women
20-59 years of age
BMI: 24.5 - 35.5 kg/m²
Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)
Disqualifiers
Allergies to peanuts and peanut products
Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs
Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological diseases or severe head injury
Smoking
Trial design
Crossover
Treatments tested in this trial
Peanuts
Dietary supplement43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for 6 months.
Treatment groups
Trial outcomes
Primary outcomes
Blood Glucose
Measurement of fasting blood glucose
Glycosylated hemoglobin
Measurement of fasting glycosylated hemoglobin
Secondary outcomes
Ambulatory Blood Pressure
Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Fasting Insulin
Measurement of fasting insulin
Homeostasis model assessment-insulin resistance (HOMA-R)
Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405
Blood Lipid Profile
Measurement of blood lipid profile
Other outcomes
Reactive Hyperemia Index
Assessment of endothelial function in response to increased shear stress using EndoPAT2000
Pulse Wave Velocity
Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor
Percent Maximal Microvascular Blood Flow
Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler
Circulating Markers of Inflammation and Oxidative Stress
Measurement of concentrations of circulating markers of inflammation such as CRP and oxidative stress such as TBARS in blood plasma and serum samples
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgia State University
Lead sponsor
United States Department of Agriculture (USDA)
Collaborator
The Peanut Institute
Collaborator