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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
72
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.
Georgia State University
Atlanta, Georgia, United States
RECRUITINGBlood 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
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