Clinical trial NCT06867198: Peanuts for Cardiometabolic, Brain, and Intestinal Health
Official title: Impact of Peanuts on Cardiometabolic, Cognitive, and Intestinal Health in Prediabetes Among Racially Diverse Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
name: The Peanut Institute
First posted: 2025-03-10
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Glucose
timeFrame: Baseline, 3 months, and 6 months
measure: Glycosylated hemoglobin
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Ambulatory Blood Pressure
timeFrame: Baseline, 3 months, and 6 months
measure: Fasting Insulin
timeFrame: Baseline, 3 months, and 6 months
measure: Homeostasis model assessment-insulin resistance (HOMA-R)
timeFrame: Baseline, 3 months, and 6 months
measure: Blood Lipid Profile
timeFrame: Baseline, 3 months, and 6 months
measure: Gut Microbiota Composition
timeFrame: Baseline, 3 months, and 6 months
measure: Global Cognitive Ability
timeFrame: Baseline, 3 months, and 6 months
measure: Performance Validity
timeFrame: Baseline, 3 months, and 6 months
measure: Verbal Memory & Recognition
timeFrame: Baseline, 3 months, and 6 months
measure: Cognitive Inhibition
timeFrame: Baseline, 3 months, and 6 months
measure: Cognitive Flexibility
timeFrame: Baseline, 3 months, and 6 months
measure: Working Memory
timeFrame: Baseline, 3 months, and 6 months
measure: Processing Speed
timeFrame: Baseline, 3 months, and 6 months
measure: Associative Memory
timeFrame: Baseline, 3 months, and 6 months
measure: Attention
timeFrame: Baseline, 3 months, and 6 months
measure: Problem-Solving
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
measure: Reactive Hyperemia Index
timeFrame: Baseline, 3 months, and 6 months
measure: Pulse Wave Velocity
timeFrame: Baseline, 3 months, and 6 months
measure: Percent Maximal Microvascular Blood Flow
timeFrame: Baseline, 3 months, and 6 months
measure: Circulating Markers of Inflammation and Oxidative Stress
timeFrame: Baseline, 3 months, and 6 months
measure: Urinary Polyphenolic Metabolites
timeFrame: Baseline, 3 months, and 6 months
measure: Body Fat
timeFrame: Baseline, 3 months, and 6 months
measure: Spontaneous brain activity at rest
timeFrame: Baseline and 6 months
measure: Blood flow (perfusion) in the brain
timeFrame: Baseline and 6 months
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Rafaela G Feresin, PhD
role: PRINCIPAL_INVESTIGATOR
References: