Clinical trial NCT06318377: Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals
Official title: Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Cognitive Decline
Diet
Healthy
Keywords: endothelial function
brain blood flow
cognition
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Individual will be randomly assigned either an experimental or a control condittion
Primary purpose: PREVENTION

Brief summary: The overall research objective of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals

Detailed description: Cardiovascular disease (CVD) is the leading cause of morbidity and mortality and affects all individuals; however, its prevalence is highest in the non-Hispanic Black (BL) population. This racial disparity is present in the primary risk factors for CVD, including hypertension, atherosclerosis, and type 2 diabetes mellitus. Furthermore, this population has the highest prevalence of various neurocognitive conditions and cerebral vascular diseases including cognitive dysfunction, dementia, stroke, and Alzheimer's disease. While the association between the BL population, neurocognitive complications/cerebral vascular diseases, and CVD is multifactorial, a common link in other populations is impaired vascular function. Indeed, vascular dysfunction.

A hallmark of impaired vascular function is elevated arterial stiffness, a decrease in the vasodilator capacity, and/or heightened sympathetic vascular transduction (i.e. vasoconstrictor response and increase in peripheral vascular resistance and arterial blood pressure to efferent sympathetic neural outflow). BL individuals have impaired endothelial function evidenced by a blunted vasodilatory response to a variety of stimuli. Reduced nitric oxide (NO) bioavailability, due to elevated oxidative stress, systemic inflammation and reduced L-arginine bioavailability, is implicated as a primary contributing factor for these attenuated vasodilatory responses. Therefore, it is reasonable to speculate that an intervention targeting these pathways could abolish or minimize this elevated risk. One such intervention could be increased dietary peanut consumption which has a beneficial effect on physiological outcomes associated with neurocognitive conditions, as well as cerebral vascular and CVD risk including, cholesterol, lipid profile, insulin sensitivity / type II diabetes, cognitive health, arterial stiffness, blood pressure, and NO bioavailability and subsequently vascular function / health. However, to our knowledge the effect of increased peanut consumption on neurocognitive and CVD risk factors in the BL population remains unknown.

Therefore, the overall research objective is of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals. The following objectives / aims will be explored:

1. Primary Aim - The primary endpoint is the effect of increased daily peanut consumption on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include cognitive function, central and peripheral arterial blood pressure, cerebral and peripheral blood vessel function/health, autonomic function - i.e. vasoconstrictor responsiveness to efferent sympathetic neural outflow (sympathetic vascular transduction), and blood biomarkers (e.g., indices of inflammation, oxidative stress, insulin resistance/diabetes risk, and lipid profile).
2. Secondary Aim - A secondary endpoint is the effect of daily peanut consumption on the following variables: body composition, body weight, and body mass index (BMI).
3. Tertiary Aim - A tertiary endpoint is to examine the relationship between the various indices of physiological health with measures of Social Determinants of Health that are well known to influence the physiological outcomes that are being measured.

Eligibility criteria: Inclusion Criteria:

* Individuals that self-identify as white or black and who have at least one biological parent who identifies as their own self-identified race/ethnicity will be included in this study. Both men and women will be included in this study. Individuals must be between the ages of 18-50.

Exclusion Criteria:

* Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then we may still opt to proceed with data collection.
* Individuals with peanut allergy
* Individuals in hypertensive crisis
* Pregnant women
* Breast feeding
* Allergies to spandex/lycra

Primary outcomes:
measure: Endothelial Function
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Neurocognitive Function
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Systolic blood pressure in brachial artery (mmHg)
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Plasma concentration of total Cholesterol (Total-C)
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Arterial stiffness
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Diastolic blood pressure in brachial artery(mmHg)
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Mean blood pressure in brachial artery (mmHg)
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Plasma concentration of Low density lipoprotein (LDL)
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Plasma concentration of High density lipoprotein (HDL)
timeFrame: baseline & following 8 weeks of daily peanut consumption
measure: Plasma concentration of Very Low density lipoprotein (VLDL)
timeFrame: baseline & following 8 weeks of daily peanut consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: UT Arlington - Science and Engineering Innovation and Research Building
state: Texas
Study officials:
affiliation: University of Texas at Arlington
name: Robert M Brothers, PhD
role: PRINCIPAL_INVESTIGATOR
References: