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Peanuts for Cardiometabolic, Brain, and Intestinal Health

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06867198
Enrollment
72
Registered
2025-03-10
Start date
2025-03-06
Completion date
2027-09-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Cognition, Microvascular Function, Gut Microbiota, Endothelial Function (Reactive Hyperemia), Arterial Stiffness, Blood Pressure, Adult

Keywords

prediabetes, peanuts, functional foods, nuts, metabolic health, insulin resistance, type II diabetes, microvascular function, dietary intervention, cognitive function, vascular function, neuroimaging, endothelial function, cardiovascular health, gut microbiota

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTPeanuts

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.

Sponsors

Georgia State University
Lead SponsorOTHER
United States Department of Agriculture (USDA)
CollaboratorFED
The Peanut Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood GlucoseBaseline, 3 months, and 6 monthsMeasurement of fasting blood glucose
Glycosylated hemoglobinBaseline, 3 months, and 6 monthsMeasurement of fasting glycosylated hemoglobin

Secondary

MeasureTime frameDescription
Ambulatory Blood PressureBaseline, 3 months, and 6 monthsAssessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Fasting InsulinBaseline, 3 months, and 6 monthsMeasurement of fasting insulin
Homeostasis model assessment-insulin resistance (HOMA-R)Baseline, 3 months, and 6 monthsCalculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405
Blood Lipid ProfileBaseline, 3 months, and 6 monthsMeasurement of blood lipid profile
Gut Microbiota CompositionBaseline, 3 months, and 6 monthsAnalysis of stool sample for determination of absolute levels of bacteria and relative species composition
Global Cognitive AbilityBaseline, 3 months, and 6 monthsMeasured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition
Performance ValidityBaseline, 3 months, and 6 monthsAssessed using Rey 15
Verbal Memory & RecognitionBaseline, 3 months, and 6 monthsMeasured using Rey Auditory Verbal Learning Test with appropriate alternate forms
Cognitive InhibitionBaseline, 3 months, and 6 monthsMeasured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention
Cognitive FlexibilityBaseline, 3 months, and 6 monthsAssessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching
Working MemoryBaseline, 3 months, and 6 monthsMeasured using Digit Span and NIH Toolbox List Sorting
Processing SpeedBaseline, 3 months, and 6 monthsMeasured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests
Associative MemoryBaseline, 3 months, and 6 monthsMeasured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests
AttentionBaseline, 3 months, and 6 monthsAssessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1
Problem-SolvingBaseline, 3 months, and 6 monthsAssessed using NIH Toolbox Visual Reasoning Test

Countries

United States

Contacts

CONTACTRafaela G Feresin, PhD
peanuts@gsu.edu404-413-1233
PRINCIPAL_INVESTIGATORRafaela G Feresin, PhD

Georgia State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026