Peanuts for Cardiometabolic, Brain, and Intestinal Health

Not Applicable

Recruiting

• Conditions: Prediabetes; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Cognition; Microvascular Function; Gut Microbiota; Endothelial Function (reactive Hyperemia); Arterial Stiffness, Blood Pressure; Adult

• Registration Number: NCT06867198
• Lead Sponsor: Georgia State University

Brief Summary

The overall objective of this 13-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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• men and women
• 20-59 years of age
• Prediabetes (fasting blood glucose levels 100-125 mg/dL and/or HbA1c between 5.7-6.4%)

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Blood Glucose	Baseline, 3 months, and 6 months	Measurement of fasting blood glucose
Glycosylated hemoglobin	Baseline, 3 months, and 6 months	Measurement of fasting glycosylated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Ambulatory Blood Pressure	Baseline, 3 months, and 6 months	Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.
Fasting Insulin	Baseline, 3 months, and 6 months	Measurement of fasting insulin
Homeostasis model assessment-insulin resistance (HOMA-R)	Baseline, 3 months, and 6 months	Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405
Blood Lipid Profile	Baseline, 3 months, and 6 months	Measurement of blood lipid profile
Gut Microbiota Composition	Baseline, 3 months, and 6 months	Analysis of stool sample for determination of absolute levels of bacteria and relative species composition
Global Cognitive Ability	Baseline, 3 months, and 6 months	Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition
Performance Validity	Baseline, 3 months, and 6 months	Assessed using Rey 15
Verbal Memory & Recognition	Baseline, 3 months, and 6 months	Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms
Cognitive Inhibition	Baseline, 3 months, and 6 months	Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention
Cognitive Flexibility	Baseline, 3 months, and 6 months	Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching
Working Memory	Baseline, 3 months, and 6 months	Measured using Digit Span and NIH Toolbox List Sorting
Processing Speed	Baseline, 3 months, and 6 months	Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests
Associative Memory	Baseline, 3 months, and 6 months	Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests
Attention	Baseline, 3 months, and 6 months	Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1
Problem-Solving	Baseline, 3 months, and 6 months	Assessed using NIH Toolbox Visual Reasoning Test

Trial Locations

Locations (1)

Georgia State University; 🇺🇸 Atlanta, Georgia, United States