Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Cognition, Microvascular Function, Gut Microbiota, Endothelial Function (Reactive Hyperemia), Arterial Stiffness, Blood Pressure, Adult
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Georgia State University