An interventional study of Peanuts in Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) and Cognition, sponsored by Georgia State University. Recruiting at 1 site in United States. Open to participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Georgia State University · Not applicable, Interventional, and Basic science
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.
In the US, 37.1 million adults have diabetes mellitus and 96 million have prediabetes. Type 2 diabetes mellitus (T2DM) accounts for 95% of the cases and results in many public health complications that increase economic burden and reduce productivity and quality of life. Eight out of 10 people with T2DM die from cardiovascular disease, while those with T2DM also face a 50% higher risk of developing dementia compared to healthy individuals. Also, studies indicate that intestinal health significantly influences the development of T2DM. Of note, the burden of T2DM is particularly pronounced in non-Hispanic Black and Hispanic populations compared to the non-Hispanic White population. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications. Plant-based foods, including peanuts and peanut products, have been increasingly recognized for their importance in the prevention and management of prediabetes and T2DM due to their unique nutritional profile, including their favorable fatty acid composition, fiber content, and bioactive compounds. While emerging evidence indicates that peanut improves cardiometabolic, cognitive and intestinal health, no studies have collectively and comprehensively evaluated the effects of peanut or peanut product consumption on the cardiometabolic, cognitive, and intestinal health of individuals with prediabetes or T2DM. Thus, this study aims to investigate whether adults with prediabetes consuming 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 six months will have 1) reduced levels of serum HbA1c, fasting glucose (FBG), insulin, HOMA-IR (homeostatic model assessment of insulin resistance) and improved lipid profile, 2) reduced blood pressure, improved endothelial function, arterial stiffness and microvascular function, 3) Improved gut microbiota composition and reduced intestinal permeability, 4) improved cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) and brain health metrics as assessed by neuroimaging, and 5) reduced serum markers of oxidative stress and inflammation. The effectiveness of the intervention on the abovementioned outcomes among races including non-Hispanic Black (NHBA), non-Hispanic White (NHWA), non-Hispanic Asian (NHAA) and Hispanic (HA) adults will also be compared. Lastly, whether changes in cardiometabolic and cognitive outcomes are associated with changes in intestinal microbiota outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 72 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Georgia State University is the lead sponsor of 56 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
MRI Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
43 g of peanut butter (1snack 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
Dietary Supplement: Peanuts
No intervention
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.
Blood Glucose
Measurement of fasting blood glucose
Time frame: Baseline, 3 months, and 6 months
Glycosylated hemoglobin
Measurement of fasting glycosylated hemoglobin
Time frame: Baseline, 3 months, and 6 months
Ambulatory Blood Pressure
Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Time frame: Baseline, 3 months, and 6 months
Fasting Insulin
Measurement of fasting insulin
Time frame: Baseline, 3 months, and 6 months
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
Blood Lipid Profile
Measurement of blood lipid profile
Time frame: Baseline, 3 months, and 6 months
Gut Microbiota Composition
Analysis of stool sample for determination of absolute levels of bacteria and relative species composition
Time frame: Baseline, 3 months, and 6 months
Global Cognitive Ability
Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition
Time frame: Baseline, 3 months, and 6 months
Performance Validity
Assessed using Rey 15
Time frame: Baseline, 3 months, and 6 months
Verbal Memory & Recognition
Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms
Time frame: Baseline, 3 months, and 6 months
Cognitive Inhibition
Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention
Time frame: Baseline, 3 months, and 6 months
Cognitive Flexibility
Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching
Time frame: Baseline, 3 months, and 6 months
Working Memory
Measured using Digit Span and NIH Toolbox List Sorting
Time frame: Baseline, 3 months, and 6 months
Processing Speed
Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests
Time frame: Baseline, 3 months, and 6 months
Associative Memory
Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests
Time frame: Baseline, 3 months, and 6 months
Attention
Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1
Time frame: Baseline, 3 months, and 6 months
Problem-Solving
Assessed using NIH Toolbox Visual Reasoning Test
Time frame: Baseline, 3 months, and 6 months
Reactive Hyperemia Index
Assessment of endothelial function in response to increased shear stress using EndoPAT2000
Time frame: Baseline, 3 months, and 6 months
Pulse Wave Velocity
Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor
Time frame: Baseline, 3 months, and 6 months
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
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
Urinary Polyphenolic Metabolites
24-hour urine collection samples will be assessed for polyphenol metabolites
Time frame: Baseline, 3 months, and 6 months
Body Fat
DEXA will be used to assess body fat.
Time frame: Baseline, 3 months, and 6 months
Spontaneous brain activity at rest
Assessed with resting state-functional Magnetic Resonance Imaging
Time frame: Baseline and 6 months
Blood flow (perfusion) in the brain
Assessed with Arterial Spin Labeling Magnetic Resonance Imaging
Time frame: Baseline and 6 months
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Studies of the drug tested here: Peanut
Georgia State University