Peanuts for Cardiometabolic, Brain, and Intestinal Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-59
SponsorGeorgia State University

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Peanuts

    Dietary supplement

    43 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

72 Participants
are divided into 2 treatment groups
Group A: PeanutExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Blood Glucose

Measurement of fasting blood glucose

Time frame
Baseline, 3 months, and 6 months
2

Glycosylated hemoglobin

Measurement of fasting glycosylated hemoglobin

Time frame
Baseline, 3 months, and 6 months

Secondary outcomes

1

Ambulatory Blood Pressure

Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.

Time frame
Baseline, 3 months, and 6 months
2

Fasting Insulin

Measurement of fasting insulin

Time frame
Baseline, 3 months, and 6 months
3

Homeostasis model assessment-insulin resistance (HOMA-R)

Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405

Time frame
Baseline, 3 months, and 6 months
4

Blood Lipid Profile

Measurement of blood lipid profile

Time frame
Baseline, 3 months, and 6 months

Other outcomes

1

Reactive Hyperemia Index

Assessment of endothelial function in response to increased shear stress using EndoPAT2000

Time frame
Baseline, 3 months, and 6 months
2

Pulse Wave Velocity

Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor

Time frame
Baseline, 3 months, and 6 months
3

Percent Maximal Microvascular Blood Flow

Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler

Time frame
Baseline, 3 months, and 6 months
4

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

Time frame
Baseline, 3 months, and 6 months

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