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NCT Number: NCT06867198

Peanuts for Cardiometabolic, Brain, and Intestinal Health

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.

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Key information

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30303, United States

Location status: Recruiting

Location contact

Andrew T Gewirtz, PhD

SUB_INVESTIGATOR

Brett J Wong, PhD

SUB_INVESTIGATOR

Elizabeth L Tighe, PhD

SUB_INVESTIGATOR

Puja K Mehta, PhD

SUB_INVESTIGATOR

Rafaela G Feresin, PhD

CONTACT

[email protected]

404-413-1233

Rafaela G Feresin, PhD

PRINCIPAL_INVESTIGATOR

Tricia Z King, PhD

SUB_INVESTIGATOR

Vince D Calhoun, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men and women
  • 20-59 years of age
  • BMI: 24.5 - 35.5 kg/m^2
  • Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)
  • Ability to give consent

Exclusion criteria

  • 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
  • Consumes greater than 2 alcoholic beverages per day
  • Consumes antioxidant, probiotic, and prebiotic supplements
  • Pregnant or Lactating
  • Actively participating in a weight loss program

MRI Exclusion Criteria:

  • Certain neurological disorders (e.g., uncontrolled seizure disorders)
  • Braces on their teeth, a cardiac pacemaker; hearing aid; other metal in the body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects

Treatment and study plan

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.

Primary outcomes

  1. Blood Glucose

    Time frame: Baseline, 3 months, and 6 months

    Measurement of fasting blood glucose

  2. Glycosylated hemoglobin

    Time frame: Baseline, 3 months, and 6 months

    Measurement of fasting glycosylated hemoglobin

Secondary outcomes

  1. Ambulatory Blood Pressure

    Time frame: Baseline, 3 months, and 6 months

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

  2. Fasting Insulin

    Time frame: Baseline, 3 months, and 6 months

    Measurement of fasting insulin

  3. Homeostasis model assessment-insulin resistance (HOMA-R)

    Time frame: Baseline, 3 months, and 6 months

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

  4. Blood Lipid Profile

    Time frame: Baseline, 3 months, and 6 months

    Measurement of blood lipid profile

  5. Gut Microbiota Composition

    Time frame: Baseline, 3 months, and 6 months

    Analysis of stool sample for determination of absolute levels of bacteria and relative species composition

  6. Global Cognitive Ability

    Time frame: Baseline, 3 months, and 6 months

    Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition

  7. Performance Validity

    Time frame: Baseline, 3 months, and 6 months

    Assessed using Rey 15

  8. Verbal Memory & Recognition

    Time frame: Baseline, 3 months, and 6 months

    Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms

  9. Cognitive Inhibition

    Time frame: Baseline, 3 months, and 6 months

    Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention

  10. Cognitive Flexibility

    Time frame: Baseline, 3 months, and 6 months

    Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching

  11. Working Memory

    Time frame: Baseline, 3 months, and 6 months

    Measured using Digit Span and NIH Toolbox List Sorting

  12. Processing Speed

    Time frame: Baseline, 3 months, and 6 months

    Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests

  13. Associative Memory

    Time frame: Baseline, 3 months, and 6 months

    Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests

  14. Attention

    Time frame: Baseline, 3 months, and 6 months

    Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1

  15. Problem-Solving

    Time frame: Baseline, 3 months, and 6 months

    Assessed using NIH Toolbox Visual Reasoning Test

Other outcomes

  1. Reactive Hyperemia Index

    Time frame: Baseline, 3 months, and 6 months

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

  2. Pulse Wave Velocity

    Time frame: Baseline, 3 months, and 6 months

    Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor

  3. Percent Maximal Microvascular Blood Flow

    Time frame: Baseline, 3 months, and 6 months

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

  4. Circulating Markers of Inflammation and Oxidative Stress

    Time frame: Baseline, 3 months, and 6 months

    Measurement of concentrations of circulating markers of inflammation such as CRP and oxidative stress such as TBARS in blood plasma and serum samples

  5. Urinary Polyphenolic Metabolites

    Time frame: Baseline, 3 months, and 6 months

    24-hour urine collection samples will be assessed for polyphenol metabolites

  6. Body Fat

    Time frame: Baseline, 3 months, and 6 months

    DEXA will be used to assess body fat.

  7. Spontaneous brain activity at rest

    Time frame: Baseline and 6 months

    Assessed with resting state-functional Magnetic Resonance Imaging

  8. Blood flow (perfusion) in the brain

    Time frame: Baseline and 6 months

    Assessed with Arterial Spin Labeling Magnetic Resonance Imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Rafaela G Feresin, PhD

CONTACT

[email protected]

404-413-1233

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • The Peanut Institute
  • United States Department of Agriculture (USDA)

Registry information

Official study title

Impact of Peanuts on Cardiometabolic, Cognitive, and Intestinal Health in Prediabetes Among Racially Diverse Populations

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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