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| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
| The Peanut Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut | Experimental | 43 g of peanut butter (1snack 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 |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose | Measurement of fasting blood glucose | Baseline, 3 months, and 6 months |
| Glycosylated hemoglobin | Measurement of fasting glycosylated hemoglobin | Baseline, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory Blood Pressure | Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods. | Baseline, 3 months, and 6 months |
| Fasting Insulin | Measurement of fasting insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Reactive Hyperemia Index | Assessment of endothelial function in response to increased shear stress using EndoPAT2000 | Baseline, 3 months, and 6 months |
| Pulse Wave Velocity | Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor |
Inclusion Criteria:
Exclusion Criteria:
MRI Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafaela G Feresin, PhD | Contact | 404-413-1233 | peanuts@gsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rafaela G Feresin, PhD | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Recruiting | Atlanta | Georgia | 30303 | United States |
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| 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 | Baseline, 3 months, and 6 months |
| Blood Lipid Profile | Measurement of blood lipid profile | Baseline, 3 months, and 6 months |
| Gut Microbiota Composition | Analysis of stool sample for determination of absolute levels of bacteria and relative species composition | Baseline, 3 months, and 6 months |
| Global Cognitive Ability | Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition | Baseline, 3 months, and 6 months |
| Performance Validity | Assessed using Rey 15 | Baseline, 3 months, and 6 months |
| Verbal Memory & Recognition | Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms | 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 | Baseline, 3 months, and 6 months |
| Cognitive Flexibility | Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching | Baseline, 3 months, and 6 months |
| Working Memory | Measured using Digit Span and NIH Toolbox List Sorting | Baseline, 3 months, and 6 months |
| Processing Speed | Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests | 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 | Baseline, 3 months, and 6 months |
| Attention | Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1 | Baseline, 3 months, and 6 months |
| Problem-Solving | Assessed using NIH Toolbox Visual Reasoning Test | Baseline, 3 months, and 6 months |
| Baseline, 3 months, and 6 months |
| Percent Maximal Microvascular Blood Flow | Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler | Baseline, 3 months, and 6 months |
| Circulating Markers of Inflammation and Oxidative Stress | Measurement of concentrations of circulating markers of inflammation such as CRP and oxidative stress such as TBARS in blood plasma and serum samples | Baseline, 3 months, and 6 months |
| Urinary Polyphenolic Metabolites | 24-hour urine collection samples will be assessed for polyphenol metabolites | Baseline, 3 months, and 6 months |
| Body Fat | DEXA will be used to assess body fat. | Baseline, 3 months, and 6 months |
| Spontaneous brain activity at rest | Assessed with resting state-functional Magnetic Resonance Imaging | Baseline and 6 months |
| Blood flow (perfusion) in the brain | Assessed with Arterial Spin Labeling Magnetic Resonance Imaging | Baseline and 6 months |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| D006940 | Hyperemia |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006943 | Hyperglycemia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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